pre-and post-transplant immunization guidelines · • defer transplant for 2 weeks (if possible)...

PRE-AND POST-TRANSPLANT IMMUNIZATION GUIDELINES

SOLID ORGAN TRANSPLANT December 2017

TABLE OF CONTENTS

1.0 INTRODUCTION ..............................................................................3

2.0 PRE-TRANSPLANT: INACTIVE VACCINES .........................................4

2.1 DIPHTHERIA/PERTUSSIS/TETANUS/ POLIO/HAEMOPHILUS INFLUENZA B ...............................................5

2.2 MENINGOCOCCAL ...........................................................................6

2.3 PNEUMOCOCCAL ............................................................................8

2.4 HEPATITIS A ..................................................................................10

2.5 HEPATITIS B ..................................................................................12

2.6 HUMAN PAPILLOMA VIRUS ............................................................14

3.0 PRE-TRANSPLANT: LIVE VACCINES ..............................................15

3.1 MEASLES MUMPS RUBELLA .........................................................16

3.2 VARICELLA ....................................................................................17

3.3 ROTAVIRUS ...................................................................................19

4.0 PRE-TRANSPLANT: INFLUENZA VACCINE .....................................20

5.0 PRE-TRANSPLANT: TRAVEL VACCINES ..........................................23

5.1 ENTEROTOXIGENIC E COLI .............................................................24

5.2 HEPATITIS A ..................................................................................25

5.3 HEPATITIS B ..................................................................................26

5.4 JAPANESE ENCEPHALITIS ..............................................................28

5.5 RABIES .........................................................................................29

5.6 TYPHOID (SALMONELLA TYPHI) ......................................................30

5.7 YELLOW FEVER .............................................................................31

6.0 POST-TRANSPLANT: INACTIVE VACCINES .....................................32

6.1 DIPHTHERIA/PERTUSSIS/TETANUS/ POLIO/HAEMOPHILUS INFLUENZA B .............................................33

6.2 MENINGOCOCCAL .........................................................................35

6.3 PNEUMOCOCCAL ..........................................................................37

6.4 HEPATITIS A ..................................................................................39

6.5 HEPATITIS B ..................................................................................41

6.6 HUMAN PAPILLOMA VIRUS ............................................................43

7.0 POST-TRANSPLANT: LIVE VACCINES .............................................44

7.1 MEASLES MUMPS RUBELLA .........................................................45

7.2 VARICELLA ....................................................................................46

7.3 ROTAVIRUS ...................................................................................47

8.0 POST-TRANSPLANT: INFLUENZA VACCINE ....................................48

9.0 POST-TRANSPLANT: TRAVEL VACCINES ........................................51

9.1 ENTEROTOXIGENIC E COLI .............................................................52

9.2 HEPATITIS A ..................................................................................53

9.3 HEPATITIS B ..................................................................................54

9.4 JAPANESE ENCEPHALITIS ..............................................................56

9.5 RABIES .........................................................................................57

9.6 TYPHOID (SALMONELLA TYPHI) ......................................................58

9.7 YELLOW FEVER .............................................................................59

1.0 INTRODUCTION

PRE-AND POST-TRANSPLANT IMMUNIZATION GUIDELINES:The following tables are suggested immunization schedules for solid organ transplant candidates and recipients. They are meant as a guide only and may not be applicable to all patients. Please consult Infectious Diseases as appropriate for patient specific issues. All costs reported are estimates only. Please consult your local pharmacy for current cost of vaccines that are not covered by the Ontario Ministry of Health and Long Term Care (MOHLTC).

PRE-TRANSPLANT CONSIDERATIONS:• Accelerated regimen schedules may be possible for some vaccines to facilitate optimal dosing and response

with limited time prior to transplant. Refer to tables for the minimum age to receive each vaccine and interval recommended for accelerated scheduling.

• Defer transplant for 2 weeks (if possible) following administration of INACTIVE vaccines to ensure adequate vaccine response.

• LIVE vaccines should be administered PRIOR to transplant when possible. Ideally transplant should not occur until at least 4 weeks following live vaccine administration.

POST-TRANSPLANT CONSIDERATIONS:• LIVE vaccines (eg. MMR, varicella, rotavirus) are contraindicated at any time post-transplant. • Routine vaccination should be restarted 12 months post-transplant to ensure optimal response, with some

exceptions as noted below:- Pneumococcal and meningococcal vaccination may be started as early as 6 months post-transplant - Influenza seasonal vaccine may be started as early as 1 month post-transplant. In the event of an outbreak,

consult Infectious Diseases.• Serological monitoring post vaccination is recommended for certain immunizations. Please refer to tables

for specific recommendations.

SIBLINGS AND OTHER FAMILY MEMBERS:All siblings should be vaccinated per routine guidelines. It is also safe for siblings of solid organ transplant recipients to receive LIVE vaccines.

TRAVEL VACCINES:• Prior to travel, all transplant candidates and recipients should consult Infectious Diseases/Travel Clinic

for recommended vaccinations. Travel Clinic consultations are not covered by the Ontario Ministry of Health and Long Term Care. Most travel vaccines are also not covered. Families will need to budget for the cost of consultation and vaccination. Some vaccines need to be administered several weeks prior to travel in order to provide adequate protection. Families will need to plan consultations well ahead of their travel date.

• Vaccine costs listed are estimates. Actual prices may vary depending on source of acquisition.

2.0 PRE-TRANSPLANT: INACTIVE VACCINES

REFERENCES:1. National Advisory Committee on Immunization (NACI). Canadian Immunization Guide. Accessed November 21,

2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.3. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice. Vaccination

in solid organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation

in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.5. Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y.

Effectiveness and safety of immunization with live-attenuated and inactivated vaccines for pediatric liver transplantation recipients. Vaccine 2015; 33: 1440-45.

6. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017. http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.

7. CDC. Recommended immunization schedules for persons aged 0 through 18 years- January 2016. Accessed November 21, 2016. http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf.

8. L’Huillier AG, Kumar D. Immunizations in solid organ and hematopoeitic stem cell transplant patients: A comprehensive review. Human Vaccines and Immunotherapeutics 2015; 11: 2852-63.

9. Sanofi Pasteur Ltd. Product Monograph-Pediacel®. March 2012. 10. GlaxoSmithKline Inc. Product Monograph-Infanrix®. July 2015.11. Sanofi Pasteur Ltd. Product Monograph-Quadracel®. August 2011. 12. GlaxoSmithKline Inc. Product Monograph-Infanrix-IPV®. September 2014.13. Sanofi Pasteur Ltd. Product Monograph-Td Adsorbed®. October 2012. 14. Sanofi Pasteur Ltd. Product Monograph-Adacel®. June 2012. 15. GlaxoSmithKline Inc. Product Monograph-Boostrix®. August 2013.16. Sanofi Pasteur Ltd. Product Monograph-Adacel®-Polio. July 2013.17. GlaxoSmithKline Inc. Product Monograph-Boostrix®-Polio. August 2013.18. GlaxoSmithKline Inc. Product Monograph-Infanrix-Hexa®. August 2016.

2.1 INACTIVE VACCINES: DIPHTHERIA, PERTUSSIS, TETANUS, POLIO AND HAEMOPHILUS INFLUENZA B – PRE-TRANSPLANT GUIDELINES

NAME OF VACCINEPRODUCTS AVAILABLE

IN CANADA

ROUTINE SCHEDULE(ONTARIO)

MINIMUM AGE FOR 1ST DOSE

MINIMUM INTERVAL BETWEEN

DOSES

NUMBER OF DOSES REQUIRED

RECOMMEND PRE-TRANSPLANT

SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

DTaP-IPV-HibPediacel®

IPV/HibInfanrix®

2, 4, 6 and 18 months

6 weeks6

Doses 1,2,3: Minimum interval is 4 weeks

Dose 3 to 4: Minimum interval is 6 months but must be repeated after 12 months1, 2, 4, 7, 9

As per routine schedule

YES

Defer transplant for 2 weeks following vaccine administration (if possible) to ensure adequate response

NOT done routinely

Covered by MOHLTC

DTaP-IPVQuadracel®

Infanrix®-IPV

4-6 years x 1 dose (May use Pediacel® if DTaP-IPV vaccines are not available)

TdTd Adsorbed®

Boosting every 10 years (adult)

7 years6

If being used as primary immunization a series of 3 doses required:

Doses 1, 2: Minimum interval is 2 months

Dose 3: To be given 6-12 months later

TdapAdacel®Boostrix®

14-16 years x 1 dose

NOTES:• D = diphtheria toxoid high dose; d = diphtheria toxoid low dose; ap or aP = acellular pertussis; T= tetanus toxoid; IPV or Polio = inactivated polio; Hib = haemophilus influenza type b; HB = hepatitis B• The following vaccines are licensed in Canada but are not part of the Ontario routine immunization schedule and are NOT covered by MOHLTC:• Tdap polio: Adacel-Polio®, Td polio: Td Polio Adsorbed®, TdaP-IPV: Boostrix®-Polio, DTap-HB-IPV-Hib: Infanrix-hexa®• Dose = 0.5 mL IM

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE: • The National Advisory Committee on Immunization (NACI) states that administering the most widely used live and inactivated vaccines during the same patient visit has produced seroconversion rates and rates of adverse reactions similar to

those observed when the vaccines are administered separately.1

• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • DTaP-IPV-Hib (Pediacel®) and DTaP-IPV ((Quadracel®) can be given at the same time as other routine vaccinations such as meningococcal C conjugate and hepatitis B.9, 11

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2.2 INACTIVE VACCINES: MENINGOCOCCAL – PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Meningococcal group C conjugate vaccine (Men-C-C)NeisVac-C®Menjugate®Meningitec®

12 months

OR

HIGH RISK* (1-10 years)

2 months

Menjugate:1 month19

NeisVac-C/Meningitec: 2 months20,21

Menjugate: 2-12 months: 3 doses

NeisVac-C/Meningitec: 2 -12 months: 2 doses, 2nd dose should be after 5 months age

>12 months: 1 dose

YES

Age at initiation:2-12 months: 2-3 doses Men-C-C, given 1-2 months apart, then Men-C-ACWY x 1 dose at 2 years

> 12-24 months:1 dose Men-C-C, then Men-C-ACWY x 1 dose at 2 years

>24 months: Transplant candidates are to be considered HIGH RISK due to impending immune-suppression:2 doses Men-C-ACWY, 8 weeks apart

Defer transplant for 2 weeks following vaccine administration to ensure adequate response

NOT done routinely

Covered per routine schedule or HIGH RISK* (1-10 years)

NOT covered for infant high risk (< 12 months)

Cost: $100/dose

Meningococcal quadrivalent ACW-135Y conjugate vaccine (Men-C-ACWY)Menactra®Menveo®Nimenrix®

Grade 7

OR

HIGH RISK* (≥ 2 years)

Menactra: 9 months4,8,16

Menveo:2 months9,16

Nimenrix®: 12 months18

1 dose only Routine: 1 dose only High Risk patients > 24 months: 2 doses

Covered under MOHLTC school program (grade 7)

OR

HIGH RISK* (9 months-55 years of age)

Cost: $100-150/dose

Serogroup B Meningococcal Vaccine (4CMenB)Bexsero® Dose = 0.5 mL

For HIGH RISK* only (2 months- 17 years)2

2 months 1 month

Age: 2-5 months: 3 doses, 1 month apart then booster at 12-23 months

Age: 6 -11 months: 2 doses, 2 months apart, followed by 3rd dose at 12-23 months AND 2 months after 2nd dose

Age: 12 months-10 years: 2 doses, 2 months apart

Age: 11-17 years: 2 doses, 1 month apart5,13

YES

Transplant candidates are considered to be at High Risk due to impending immune-suppression

Covered by MOHLTC for HIGH RISK* ONLY

Cost: $200-250/dose

*HIGH RISK: 1. Functional/anatomic asplenia2. Complement, properdin, factor D or primary antibody deficiencies3. Cochlear implants (pre/post implant)4. HIV+5. Persons with acquired complement deficiencies due to receipt of the terminal complement inhibitor eculizumab

(Soliris™) 1,2 • Increased risk of exposure: travelers where meningococcal vaccine is recommended (meningitis belt of Sub-Saharan

Africa) or required (Hajj, Mecca)1

CONTRAINDICATIONS:In persons with history of anaphylaxis after a previous dose of the vaccine and in patients with proven hypersensitivity/anaphylaxis to any component of the vaccine or its container.1

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• The National Advisory Committee on Immunization (NACI) states that administering the most widely used live

and inactivated vaccines during the same patient visit has produced seroconversion rates and rates of adverse reactions similar to those observed when the vaccines are administered separately.1

• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • Men-C-C products, Menactra® and Bexsero® can be given with other routine childhood immunizations, in a different

injection site with a separate needle and syringe1. Per NACI, Menveo® administration at the same time as PCV13 requires further study.1 However, the Menveo® product monograph indicates concomitant administration with other routine childhood immunizations is appropriate (separate injection site and syringe).9

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2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.3. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice. Vaccination

in solid organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation

in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.5. Meningococcal B Pilot Project Task Group. The recommended use of the multicomponent

meningococcal B (4CMenB) vaccine in Canada: common guidance statement. Pan-Canadian Public Health Network. March 26, 2014. Retrieved Feb 8, 2016. http://publications.gc.ca/collections/collection_2014/aspc-phac/HP40-103-2014-eng.pdf.

6. Avery RK, Michaels M. Update on immunizations in solid organ transplant recipients: What clinicians need to know? American Journal of Transplantation 2008; 8: 9-14.

7. Report from Advisory Committee on Immunization Practices (ACIP): Decision not to recommend routine vaccination of all children aged 2-10 years with quadrivalent meningococcal conjugate vaccine. MMWR Morbidity and Mortality Weekly Report 2008; 57: 462-465.

8. Sanofi Pasteur Ltd. Product Monograph-Menactra®. June 2012.9. Novartis Vaccines and Diagnostics Inc. Product Monograph-Menveo™. November 2014. 10. Advisory Committee on Immunization Practices 2011 Immunization schedules.

http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm.

11. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.

12. Allen UD. Minimizing infection risks after paediatric organ transplant: advice for practitioners. Canadian Paediatric Society Infectious Diseases and Immunization Committee. Paediatric Child Health 2013;18(3):143-8.

13. Novartis Vaccines and Diagnostics Inc. Product Monograph-Bexsero®. November 2013.14. Kumar D. Immunizations following solid-organ transplantation. Current Opinion in Infectious Disease

2014; 27: 329-335.15. L’Huillier AG, Kumar D. Immunizations in solid organ and hematopoeitic stem cell transplant patients:

A comprehensive review. Human Vaccines and Immunotherapeutics 2015; 11: 2852-63. 16. CDC. Recommended immunization schedules for persons aged 0 through 18 years - January 2016.

Accessed November 21, 2016. http://www.cdc.gov/vaccines/schedules/downloads/child/ 0-18yrs-child-combined-schedule.pdf.

17. Allen UD, Green M. Prevention and treatment of infectious complications after solid organ transplantation in children. Pediatric Clinics of North America 2010; 57(2):459-79.

18. GlaxoSmithKline Inc. Product Monograph-Nimenrix®. June 2015. 19. GlaxoSmithKline Inc. Product Monograph-Menjugate®. December 2015.20. Pfizer Canada Product Monograph-NeisVac-C®. March 2015.21. Nuron Biotech Inc Product Monograph-Meningitec®. September 2013.22. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed)

Red Book: 2015 Report of the Committee on Infectious Diseases (30th edition). Elk Grove Village, IL: American Academy of Pediatrics.

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2.3 INACTIVE VACCINES: PNEUMOCOCCAL – PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Pneumococcal Conjugate Vaccine (PCV)Prevnar® (PC13)

Synflorix® (PC10)

2, 4, 6 and 15 months for HIGH RISK*

2, 4 and 12 months for other children

6 weeks 8 weeks1,2

3-4 doses for high risk (schedule dependent on age)

< 5 yrs: follow MOHLTC schedule for high risk (see Tables 1 and 2 on next page)

> 5yrs, NOT previously immunized: 2 doses PCV, 4-6 weeks apart¥, then 1 dose PPV (6-8 weeks post last PCV dose) followed by 2nd PPV dose 5 years later1

YES

Defer transplant for 2 weeks following vaccine administration to ensure adequate response

NOT done routinely

Covered by MOHLTC per routine schedule for ≤ 5 years age2

(Prevnar® only)

Pneumococcal Polysaccharide Vaccine (PPV)Pneumovax® 23

2 doses for high risk ≥ 2 years

NOT routine for other children

2 years2 doses for high risk; minimum 6-8 weeks post conjugate vaccine

≥ 2 years: 1 dose, 6-8 weeks post PCV administration (after completion of age appropriate PCV series)

THEN

2nd dose ≥ 5 years after first dose

2 doses covered by MOHLTC for high risk ≥ 2 years age

NOTES:• *NACI: Children 2 to < 5 years of age at increased risk of invasive pneumococcal disease (IPD) should receive pneumococcal conjugate vaccine, with pneumococcal polysaccharide vaccine as a booster dose to increase the serotype coverage.

Children at increased risk of IPD include those who attend child care centres, are Aboriginal, have sickle cell disease/sickle cell hemoglobinopathies, have other types of functional or anatomic asplenia, HIV infection, are immunocompromised (e.g., primary immunodeficiencies; malignancies; immunosuppressive therapy, solid organ transplantation, use of long-term systemic corticosteroids; nephrotic syndrome), chronic medical conditions (e.g., chronic cardiac or pulmonary disease such as bronchopulmonary dysplasia, diabetes mellitus, chronic renal disease or CSF leak) and children with cochlear implants/receiving cochlear implants1

• ¥ Expert opinion

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• The National Advisory Committee on Immunization (NACI) states that administering the most widely used live and inactivated vaccines during the same patient

visit has produced seroconversion rates and rates of adverse reactions similar to those observed when the vaccines are administered separately.1

• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1

— 9 —

REFERENCES:1. National Advisory Committee on Immunization (NACI). Canadian Immunization Guide, 7th Edition. Accessed

November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.3. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice.

Vaccination in solid organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation in the pediatric

solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.5. Pfizer Canada Inc. Product Monograph-Prevnar 13®. December 2015.6. Merck Canada Inc. Product Monograph-Pneumovax®23. July 2016. 7. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.

8. Allen UD. Minimizing infection risks after paediatric organ transplant: advice for practitioners. Canadian Paediatric Society Infectious Diseases and Immunization Committee. Paediatric Child Health 2013;18(3):143-8

9. Kumar D. Immunizations following solid-organ transplantation. Current Opinion in Infectious Disease 2014; 27: 329-335.

10. CDC. Recommended immunization schedules for persons aged 0 through 18 years - January 2016. Accessed November 21, 2016. http://www.cdc.gov/vaccines/schedules/downloads/child/ 0-18yrs-child-combined-schedule.pdf

11. GlaxoSmithKline Inc. Product Monograph-Synflorix®. April 201612. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed)

Red Book: 2015 Report of the Committee on Infectious Diseases (30th edition). Elk Grove Village, IL: American Academy of Pediatrics. 632-636.

TABLE 1: CHILDREN < 5 YEARS NOT PREVIOUSLY IMMUNIZED WITH THE PNEUMOCOCCAL VACCINE

AGE AT FIRST DOSE APPLIES TO PREVNAR® (PCV13) MINIMUM INTERVALS

6 weeks-6 months High Risk*

Dose 1: age ≥ 6 weeksDose 2: 8 weeks after 1st doseDose 3: 8 weeks after 2nd doseDose 4*: 8 weeks after 3rd dose AND at age ≥ 12 months

7-11 months AllDose 1: Day 0Dose 2: 8 weeks after 1st doseDose 3: 8 weeks after 2nd dose AND at age ≥ 12 months

12-23 months AllDose 1: Day 0Dose 2: 8 weeks after 1st dose

24-59 months (2-5 years)

All 1 dose only

Adapted from Publicly Funded Immunization Schedules for Ontario2

** 4 weeks minimal interval between doses with vaccine manufacturers but CIG (NACI) recommends minimal interval to be 8 weeks.

• High risk patients get 4 doses of PCV only if aged 6 weeks to 6 months at first dose.• High risk patients get 2 PPV doses; PPV 1 dose ≥ 8 weeks after last PCV dose and age ≥ 2 years,

2nd dose ≥ 5 years after 1st dose

TABLE 2: CHILDREN < 5 YEARS OF AGE WHO HAVE INTERRUPTED OR INCOMPLETE VACCINATION

CURRENT AGE APPLIES TO

NUMBER OF PCV DOSES PREVIOUSLY RECEIVED

NUMBER OF PCV DOSES REQUIRED TO COMPLETE SERIES

2-6 monthsHigh Risk*

1 Dose

Dose 2: 2 months after 1st doseDose 3: 2 months after 2nd doseDose 4: 2 months after 3rd dose AND at age ≥ 12 months

2 DosesDose 3: 2 months after 2nd doseDose 4: 2 months after 3rd dose AND at age ≥ 12 months

7-11 months All

1 DoseDose 2: 2 months after 1st doseDose 3: 2 months after 2nd dose AND at age ≥ 12 months

2 DosesDose 3: 2 months after 2nd dose AND at age ≥ 12 months

12-23 months All

Dose 1 at age < 12 monthsDose 2: 2 months after 1st doseDose 3: 2 months after 2nd dose

Dose 1 at age ≥ 12 months Dose 2: 2 months after 1st dose

Dose 1 at age < 12 months AND dose 2 at age ≥ 12 months

Dose 3: 2 months after 2nd dose

2 or more doses at age < 12 months1 Dose, 2 months after the most recent dose


All Any incomplete series1 Dose, 2 months after the most recent dose

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2.4 INACTIVE VACCINES: HEPATITIS A – PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Hepatitis AAvaxim®Avaxim Ped®Havrix®Havrix Jr®Vaqta®Vaqta Ped®(can be used interchangeably) None 6 months1

Monovalent vaccines: 6 months1

Twinrix®: 6 months

Twinrix® Junior: 1 month between first and second dose; 6 months between second and third dose

2 dose schedule: 0 and 6-12 months

Recommended for ALL transplant candidates, but in particular for High Risk* patients

Hepatitis A vaccine may be given either as a monovalent product or in combination with hepatitis B; dosing is different

NACI does not recommend the use of Twinrix® or Twinrix® Junior in functionally immunosuppressed or hyporesponsive patients (example ESRD dialysis patients)1

Defer transplant for 2 weeks following vaccine administration to ensure adequate response1

NO**

Covered by ON MOHLTC only for patients with chronic liver disease

Cost: $40-80/dose

See table 2 for Twinrix® and Twinrix® Junior dosing

Combination Hep A/B VaccinesTwinrix®Twinrix Junior®

High Risk* includes persons travelling to endemic countries, residents in native communities, institutionalized patients

**High response rate to immunization makes routine post immunization serologic testing unnecessary in healthy populations. Commercial assay kits are not universally reliable for detecting vaccine-induced antibody ¹,²

TABLE 1: CANADIAN IMMUNIZATION GUIDE (NACI) - HEPATITIS A DOSING RECOMMENDATIONS FOR MONOVALENT HEPATITIS A VACCINES1

VACCINE ANTIGEN* VOLUME SCHEDULE (BOOSTER) AGEʈ

Avaxim® 160 antigen units HAV 0.5 mL 0, (6-12) months 12 years and older

Avaxim Ped® 80 antigen units HAV 0.5 mL 0, (6-12) months 1 to 15 years

Havrix® 1440 ELISA units HAV 1 mL 0, (6-12) monthsǂ 19 years and older

Havrix Jr® 720 ELISA units HAV 0.5 mL 0, (6-12) months 1 to 18 years

Vaqta® 50 units HAV 1 mL 0, (6-18) months 18 years and older

Vaqta Ped® 25 units HAV 0.5 ml 0, (6-18) months 2 to 17 years

*There is no international standard for HAV measurement. Each manufacturer uses its own units of measurement.ʈ Ages for which the vaccine is approved ǂ Studies have shown that 720 ELISA units provides an effective booster dose in those over 19 years of age

NOTE:• Comparable to the results reported in clinical trials of children more than 12 months of age, all reviewed

studies have consistently shown that vaccination of infants 6 to 12 months of age with inactivated HA vaccines is immunogenic and safe.

TABLE 2: TWINRIX® DOSING SCHEDULE1

RECIPIENTS TWINRIX® TWINRIX JR®

ANTIGEN* mL SCHEDULE (MONTHS) ANTIGEN* mL SCHEDULE (MONTHS)

6 months- 15 years

720 ELISA units

1 0, 6-12360 ELISA units

0.5 0, 1, 6

16-18 years - - -360 ELISA units

0.5 0, 1, 6

CONTRAINDICATIONS: • In persons with a history of anaphylaxis after previous administration of a HA-containing vaccine and in persons

with proven immediate or anaphylactic hypersensitivity to any component of the product or its container.11 TWINRIX® and TWINRIX® Junior: latex in plunger stopper of pre-filled syringe, neomycin, yeast11

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• The National Advisory Committee on Immunization (NACI) states that administering the most widely used live and

inactivated vaccines during the same patient visit has produced seroconversion rates and rates of adverse reactions similar to those observed when the vaccines are administered separately.1

• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • Since HAVRIX® is an inactivated vaccine, its concomitant use with other inactivated vaccines is unlikely to result in

interference with immune responses. When concomitant administration of other vaccines is considered necessary, the vaccines must be given with different syringes and at different injection sites.10

— 11 —

REFERENCES:1. National Advisory Committee on Immunization (NACI). Canadian Immunization Guide, 7th Edition. Accessed

November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Publicly funded immunization schedules for Ontario -December 2016. Accessed April 27, 2017.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.3. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice. Vaccination in solid

organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.5. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation

in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.



8. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed) Red Book: 2015 Report of the Committee on Infectious Diseases (30th edition). Elk Grove Village, IL: American Academy of Pediatrics.

9. Martin K, Drabble A, Manlhiot C, Dipchand AI. Response to hepatitis A and B vaccination after pediatric heart transplant. Pediatric Transplantation 2012; 16: 699-703.

10. GlaxoSmithKline Inc. Product Monograph-Havrix®. March 2016.11. GlaxoSmithKline Inc. Product Monograph-Twinrix®. August 2016. 12. Sanofi Pasteur Ltd. Product Monograph-Avaxim Pediatric®. October 2015.

— 12 —

2.5 INACTIVE VACCINES: HEPATITIS B – PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Hepatitis BEngerix®-B

OR

Recombivax HB®(can be used interchangeably)

Grade 7 (12 years)

2 doses(0, 6 months)

Newborn Varied accelerated schedules available

ACCELERATED SCHEDULES:4 dose:0, 7, 21-28 days, and booster at 6-12 months

3 dose:0, 1, > 2 months2

3 dose schedule preferred:0, 1, 6 months

YES*see tables 1 and 2 below for dosing

If functionally immunosuppressed or hyporesponsive, consider double the microgram dose for age and use 3 or 4 dose schedule (example ESRD dialysis, patients receiving immunosuppressive therapy)

NACI does not recommend the use of Twinrix® or Twinrix® Junior in functionally immunosuppressed or hyporesponsive patients (example ESRD dialysis patients)1

Defer transplant for 2 weeks following vaccine administration to ensure adequate response1

YES

6-8 weeks post series

Annually post series to assess ongoing immunity

If seronegative, repeat vaccine series x1

If non-responsive with repeat series, consult ID

Monovalent vaccines covered by ON MOHLTC school program (grade 7) -2 doses only

Covered < 7 years age immigrated from countries of high prevalence or exposed to family carriers

Doses 2 and 3 covered for patients2:-on dialysis or receiving frequent blood products-listed for transplant-chronic liver disease

Combination Hepatitis B Vaccines:Hepatitis A +B: Twinrix®Twinrix Junior®

DTaP-HB-IPV-HibINFANRIX hexa™

6 months1 See Table 3 for Twinrix® and Twinrix® Junior dosing

TABLE 1: CANADIAN IMMUNIZATION GUIDE (NACI)- HEPATITIS B STANDARD DOSING RECOMMENDATIONS1 FOR PAEDIATIC PATIENTS

(3 OR 4 DOSE SCHEDULE ONLY):

RECIPIENTS RECOMBIVAX HB® ENGERIX®-B

µg mL SCHEDULE (MONTHS) µg mL SCHEDULE (MONTHS)

Infants(regardless of mothers’ HBV status)

5 0.5 0, 1, 6** 10 0.5 0, 1, 6 OR 0, 1, 2, 12

Children 12 months -19 years

5 0.5 0, 1, 6** 10 0.5 0, 1, 6 OR 0, 1, 2, 12

*Thimerosal preservative-free preparation is recommended

**Although a schedule of 0, 1 and > 2 months is approved, the preferred schedule is 0, 1, and 6

TABLE 2: HEPATITIS B-REVISED DOSING GUIDELINES FOR TRANSPLANT (ADAPTED FROM CANADIAN IMMUNIZATION GUIDE-NACI)

NOTE: DOSES LISTED ARE DOUBLE THE ROUTINE AGE RECOMMENDED DOSE



Infants (regardless of mothers’ HBV status)

10 1 0, 1, 6** 20 1 0, 1, 6 OR 0, 1, 2, 12

Children 12 months -19 years

10 1 0, 1, 6** 20 1 0, 1, 6 OR 0, 1, 2, 12

*Thimerosal preservative-free preparation recommended;

**Although schedule of 0, 1 and > 2 months is approved, the preferred schedule is 0, 1, and 6

— 13 —

TABLE 3: TWINRIX® DOSING SCHEDULE PRE-TRANSPLANT1



6 months -15 years

20 1 0, 6 -12 10 0.5 0, 1, 6

16-18 years - - - 10 0.5 0, 1, 6

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• The National Advisory Committee on Immunization (NACI) states that administering the most widely used

live and inactivated vaccines during the same patient visit has produced seroconversion rates and rates of adverse reactions similar to those observed when the vaccines are administered separately.1

• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • According to the National Advisory Committee on Immunization (NACI), RECOMBIVAX HB® (hepatitis B vaccine

[recombinant]) may be administered simultaneously with other vaccines at different sites. A separate needle and syringe should be used for each vaccine.14

CONTRAINDICATIONS: • In persons with a history of anaphylaxis after previous administration of a HB-containing vaccine and in persons

with proven immediate or anaphylactic hypersensitivity to any component of the product or its container.11

• TWINRIX® and TWINRIX® Junior: latex in plunger stopper of pre-filled syringe, neomycin, yeast.11

REFERENCES:1. NACI. Canadian Immunization Guide, 7th Edition. Accessed November 21, 2016 and April 27, 2017.

http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017.


organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. European Consesnsus Group on Hepatitis B Immunity. Are booster immunisations needed for lifelong

hepatitis B immunity? Lancet 2000; 355: 561-565.5. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.6. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation in the

pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.7. Kumar D. Immunizations following solid-organ transplantation. Current Opinion in Infectious Disease 2014;

27: 329-335.


9. Leung DH, Ton-That M, Economides JM, Healy CM. High prevalence of hepatitis B non-immunity in vaccinated pediatric liver transplant recipients. American Journal of Transplantation 2015; 15: 535-540.


11. GlaxoSmithKline Inc. Product Monograph-Twinrix®. August 2016. 12. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed)


13. GlaxoSmithKline Inc. Product Monograph-Engerix B®. September 2015.14. Merck Canada Inc. Product Monograph-Recombivax®. May 2012.

— 14 —

REFERENCES:1. NACI. Canadian Immunization Guide, 7th Edition. Accessed November 21 2016 and April 27, 2017.

http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Publicly funded immunization schedules for Ontario -December 2016. Accessed April 27, 2017.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.3. Merck Canada Inc. Product Monograph-Gardasil®. February 2015.4. Merck Canada Inc. Product Monograph-Gardasil®9. December 2016.5. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation

in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.6. CDC. Recommended immunization schedules for persons aged 0 through 18 years - January 2016.


7. GlaxoSmithKline. Product Monograph-Cervarix®. November 2014.8. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed)



10. Benden C, Danziger-Isakov LA, Astor T, et al. Variability in immunization guidelines in children before and after lung transplantation. Pediatric Transplantation 2007; 11: 882-887.

11. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice. Vaccination in solid organ transplantation. American Journal of Transplantation 2013; 13: 311-17.



14. Kidney Disease: Improving Global Outcomes Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. American Journal of Transplantation 2009; 9 (Suppl. 3):S1-S155.

2.6 INACTIVE VACCINES: HUMAN PAPILLOMA VIRUS – PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Human Papilloma VirusGardasil®(quadrivalent HPV 4 type 6, 11, 16, 18)

Gardasil®/Gardasil® 9 (9-valent HPV 9 type 6, 11, 16, 18, 31, 33, 45, 52, 58)

Cervarix®(bivalent HPV 2 type 16, 18)

Grade 7 femalesand males

9 years1,2

Gardasil® and Gardasil® 9are approved in females between 9 and 45 years and in males between 9 and 26 years.1,3,4

Cervarix® is approved in females between 9 and 45 years1,7

4 weeks between first and second dose

12 weeks between second and third dose1,2

Third dose at least 24 weeks after first dose1,2

Gardasil®/Gardasil® 9 3 doses: 0, 2 and 6 months1,2

Immunocompetent patients 9-14 years of age at time of first injection may receive HPV vaccine on a 2 dose schedule (0 and 6 months)1

If schedule interrupted, series does not need to be restarted5

YES

Recommend if patient > 9 years of age and is a transplant candidate5,6,11,12

NO

Gardasil® iscovered under ON MOHLTC school program (grade 7) for females and males

Gardasil® 9 will be covered in Ontario when Gardasil® supply deleted. Cost: $180/dose

Cervarix®Not covered in OntarioCost: $100-150/dose

NOTES:• Dose 0.5 mL IM• Higher incidence of fainting in younger individuals; observe patients for full 15 minutes post dose



• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • GARDASIL® may be administered concomitantly (at a separate injection site) with Menactra* [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine],

Adacel* [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)], and RECOMBIVAX HB® [hepatitis B vaccine (recombinant)]3

• GARDASIL®9 may be administered concomitantly (at a separate injection site) with Menactra* [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel* [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)], and Poliomyelitis (inactivated) Vaccine.4

3.0 PRE-TRANSPLANT: LIVE VACCINES

— 16 —

REFERENCES:1. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.2. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.3. Merck Canada Inc. Product Monograph-ProQuad®. June 2015. 4. NACI (2006). Canadian Immunization Guide. Accessed November 21, 2016 and April 27, 2017.

http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.5. Danziger-Isakov L, Kumar D. AST Infectious Diseases Community of Practice. Vaccination in solid

organ transplantation. American Journal of Transplantation 2013; (Suppl. 4):311-7.6. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation

in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.7. L’Huillier AG, Kumar D. Immunizations in solid organ and hematopoeitic stem cell transplant patients:

A comprehensive review. Human Vaccines and Immunotherapeutics 2015; 11: 2852-63. 8. GlaxoSmithKline Inc. Product Monograph-PRIORIX-TETRA™. October 2014. 9. GlaxoSmithKline Inc. Product Monograph-PRIORIX®. January 2015. 10. Merck Canada Inc. Product Monograph-MMR-II®. June 2015. 11. Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y.


12. Shinjoh M, Hoshino K, Takahashi T, Nakayama T. Updated data on effective and safe immunizations with live-attenuated vaccines for children after living donor liver transplantation. Vaccine 2015; 33: 701-707.

13. L’Huillier AG, Posfay-Barbe KM. Live viral vaccines in immunocompromised patients. Future Virology 2014; 9: 161-171.

14. Verolet CM, Posfay-Barbe KM. Live Virus Vaccines in Transplantation: Friend or Foe? Current Infectious Disease Reports 2015; 17: 472-83.


16. CDC. Recommended immunization schedules for persons aged 0 through 18 years - January 2016. Accessed November 21, 2016. http://www.cdc.gov/vaccines/schedules/downloads/child/ 0-18yrs-child-combined-schedule.pdf.

17. American Academy of Pediatrics. Immunization in immunocompromised children. In: Red Book: 2015 Report of the Committee on Infectious Diseases, 30th ed, Kimberlin DW, Brady MT, Jackson MA, Long SS. (Eds), American Academy of Pediatrics, Elk Grove Village, IL 2015. p.74.

18. Rand EB, McCarthy CA, Whitington PF. Measles vaccination after orthotopic liver transplantation. Journal of Pediatrics 1993; 123:87-9.

19. Kano H, Mizuta K, Sakakihara Y, et al. Efficacy and safety of immunization for pre-and post-liver transplant children. Transplantation 2002; 74: 543-50.

20. Khan S, Erlichman J, Rand EB. Live virus immunization after orthotopic liver transplantation. Pediatric Transplant 2006; 10: 78-82.

21. Shinjoh M, Miyairi I, Hoshino K, et al. Effective and safe immunizations with live-attenuated vaccines for children after living donor liver transplantation. Vaccine 2008; 26: 6859-63.

3.1 LIVE VACCINES: MEASLES MUMPS RUBELLA – PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Priorix® (MMR)

MMR-II® (MMR)

MMR at 12 months

6 months 4 weeks-6 weeks2, 4, 5, 6, 7 9,10 in consultation with Infectious Diseases

2 doses recommended:

Initial dose at 12 months (MMR); second dose at 4-6 years in combination with varicella (MMRV)2

If first dose given < 12 months, second dose to be given ≥ 12 months to enhance probability of adequate response

YES

Ideally defer transplant for 4 weeks following vaccine administration1,6

May be done prior to vaccination

Post-serology NOT routinely recommended

Covered by MOHLTCPriorix-Tetra® (MMR-V)

ProQuad® (MMR-V)3

MMRV at 4-6 years

Priorix-Tetra®: 9 months

ProQuad®: 12 months

4 weeks minimum2,3,10,16

In consultation with Infectious Diseases

NOTES:• Use of immune globulin or other antibody-containing blood products: Delay immunization for 3 to 11 months depending on the product [https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-

guide-part-1-key-immunization-information/page-11-blood-products-human-immune-globulin-timing-immunization.html] to avoid vaccine failure secondary to passively acquired varicella/measles antibodies.• Blood products of human origin contain significant amounts of antibodies to infectious agents such as measles virus and varicella zoster virus (VZV). Administration of IVIG preparations can interfere with the immune responses

to live virus vaccines given concomitantly with or shortly before or after the vaccine. The duration of interference with the immune response to the vaccine is related to the amount of antibody in the Ig preparation.4,16

• If the interval between administration of any of these vaccines and subsequent administration of an IVIG preparation is less that the recommended intervals [https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-1-key-immunization-information/page-11-blood-products-human-immune-globulin-timing-immunization.html], immunization should be repeated at 3 months or longer, unless serologic test indicates that the antibodies were produced.4.16

• Egg allergy is NOT a contraindication to MMR or MMRV vaccine-trace amount of egg protein appears insufficient to elicit a hypersensitivity reaction in egg allergic individuals.4

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• Measles, mumps and rubella vaccine may be given at the same time as the inactivated polio vaccine (IPV), diphtheria, tetanus and pertussis vaccines (DTPw/DTPa) and Haemophilus influenzae type b (Hib)

if they are administered at separate injection sites.4, 9, 10

• Per NACI, a minimum interval of 4 weeks between 2 varicella-containing vaccines is acceptable under exceptional circumstances.4

— 17 —

3.2 LIVE VACCINES: VARICELLA – PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Varivax®III (Varicella only)

Varilrix® (Varicella only)

Priorix-Tetra® (MMR-V)

ProQuad® (MMR-V)

15 months(varicella alone)

4-6 years(varicella + measles/mumps/ rubella)

12* months (varicella alone)

Varivax®:4 weeks8, 10, 12, 13, 25

Varilix®26:6 weeks 2 doses recommended

Initial dose as varicella vaccine; second dose in combination with MMR

YES

Ideally defer transplant for 4 weeks following vaccine administration1,10

YES

Check serology minimum 4-6 weeks8,11

following last dose

Covered under MOHLTC

Priorix-Tetra®: 9 months3

ProQuad®: 12 months2

4 weeks minimum2,10,16,17

NOTES:• *Varicella vaccine may be given at 9 months of age3, 8, 11, 12, 26 in consultation with Infectious Diseases• Use of immune globulin or other antibody-containing blood products: Delay immunization for 3 to 11 months depending on the product [https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-

guide-part-1-key-immunization-information/page-11-blood-products-human-immune-globulin-timing-immunization.html] to avoid vaccine failure secondary to passively acquired varicella/measles antibodies.• Blood products of human origin contain significant amounts of antibodies to infectious agents such as measles virus and varicella zoster virus (VZV). Administration of IVIG preparations can interfere with the immune responses

to live virus vaccines given concomitantly with or shortly before or after the vaccine. The duration of interference with the immune response to the vaccine is related to the amount of antibody in the Ig preparation.13,14

• If the interval between administration of any of these vaccines and subsequent administration of an IVIG preparation is less that the recommended intervals [https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-1-key-immunization-information/page-11-blood-products-human-immune-globulin-timing-immunization.html], immunization should be repeated at 3 months or longer, unless serologic test indicates that the antibodies were produced.13,14

• Refer to product monographs for information regarding potential allergens such as neomycin, gelatin and egg protein• Contraindicated in patients with history of anaphylaxis after previous administration of the vaccine or with proven immediate/anaphylactic hypersensitivity to any component of the product.• Egg allergy is NOT a contraindication to MMRV vaccine-trace amount of egg protein appears insufficient to elicit a hypersensitivity reaction in egg allergic individuals.14

• Close contacts should be vaccinated against varicella if they do not have a previous history of chicken pox. Isolate contacts from the transplant recipient if they develop a varicella-like rash (> 50 lesions)7, 27

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• Varicella vaccine can be administered concomitantly with diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTaP) and Haemophilus b (Hib) conjugate vaccine. • MMR vaccine can be administered concomitantly with diphtheria and tetanus toxoids and pertussis vaccine adsorbed, Haemophilus b conjugate vaccine and inactivated polio (IPV) vaccine if given at separate sites.4,9,10

• MMRV vaccines: Priorix Tetra® can be given at the same time as DTaP, Hib and IP vaccines if administered at separate sites.3 ProQuad® can be given at the same time as Hib, Hepatitis B, Hepatitis A and pneumococcal vaccines if given at separate sites. There is insufficient evidence with DTaP and no data with IP vaccine.2

— 18 —


for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.2. Merck Canada Inc. Product Monograph-ProQuad®. June 2015.3. GlaxoSmithKline Inc. Product Monograph-PRIORIX-TETRA™. October 2014.4. Shinjoh M, Hoshino K, Takahashi T, Nakayama T. Updated data on effective and safe immunizations with

live-attenuated vaccines for children after living donor liver transplantation. Vaccine 2015; 33: 701-707.5. Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y. Effectiveness

and safety of immunization with live-attenuated and inactivated vaccines for pediatric liver transplantation recipients. Vaccine 2015; 33: 1440-45.

6. Posfay-Barbe KM, Pittet LF, Sottas C, Grillet S, Wildhaber BE, Rodriguez M, et al. Varicella-zoster immunization in pediatric liver transplant recipients: safe and immunogenic. American Journal of Transplantation 2012; 12: 2974-85.

7. Pergam SA, Limaye AP, AST Infectious Disease Community of Practice. Varicella zoster virus in solid organ transplant recipients. American Journal of Transplantation 2013; 13: 138-146.



10. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.




14. NACI. Canadian Immunization Guide. Accessed January 26, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.




18. Mizuta K, Urahashi T, Ihara Y, et al. Varicella zoster virus disease after pediatric living donor liver transplantation: is it serious? Transplantation Proceedings 2012; 44:780-783.

19. Pittet LF, Posfay-Barbe KM. Immunization in transplantation: review of the recent literature. Current Opinion in Organ Transplantation 2013; 18: 543-548.

20. Danerseau AM, Robinson JL. Efficacy and safety of measles, mumps, rubella and varicella live viral vaccines in transplant recipients receiving immunosuppressive drugs. World Journal of Pediatrics 2008; 4: 254-258.


22. Zamora I, Simon JM, Da Silva ME, Piqueras AI. Attenuated varicella virus vaccine in children with renal transplants. Pediatric Nephrology 1994; 8:190-2.

23. Weinberg A, Horslen SP, Kaufman SS, et al. Safety and immunogenicity of varicella-zoster virus vaccine in pediatric liver and intestine transplant recipients. American Journal of Transplantation 2006; 6:565-8.

24. Donati M, Zuckerman M, Dhawan A, et al. Response to varicella immunization in pediatric liver transplant recipients. Transplantation 2000; 70:1401-4.

25. Merck Canada Inc. Product Monograph Varivax® III. April 2016.26. Glaxo Smith Kline Inc. Product Monograph Varilix®. October 2014.27. Seward JF, Zhang JX, Maupin TJ, Mascola L, Jumaan AO. Contagiousness of varicella in vaccinated cases:

A household contact study. JAMA 2004; 292: 704-708.

— 19 —

REFERENCES1. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.2. National Advisory Committee on Immunization. (NACI). Canadian Immunization Guide. Accessed November 21,

2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.


4. Rotarix® Product Monograph. Glaxo Smith Kline. January 2016.

3.3 LIVE VACCINES: ROTAVIRUS – PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Rotavirus oral vaccineRotarix®

RotaTeq® (not interchangeable)

2 dose schedule:

2, 4 months (Rotarix®)1, 2

MIN: 6 weeks2

MAX: 14 weeks + 6 days2 (<15 weeks of age)

4 weeks2

Rotarix® 2 doses2

All doses completed by 8 months age2,3

Both doses completed by <25 weeks of age1 (in order to be covered by MOHLTC)

YES as per suggested schedule if no contraindication

NO

Covered under MOHLTC for infants: 6-24 weeks of age

Rotarix®: $95/dose

RotaTeq®: NOT covered in Ontario

NOTES:• Contraindicated with history of intussusceptions. • Contraindicated following Kasai procedure.• Live virus sheds in stool; care with diaper changes.• Typically NOT be given in hospital due to risk of transmission. • Siblings may receive vaccine however careful handwashing recommended. Older transplant recipients should not change/handle their vaccinated sibling’s diapers for 10 days following vaccine dose.

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• ROTARIX® may be given at the same time as other routine vaccinations (diphtheria, tetanus, pertussis, Haemophilus influenzae type b, inactivated polio, hepatitis B,

pneumococcal vaccines as well as meningococcal serogroup C conjugate vaccine).4

4.0 PRE-TRANSPLANT: INFLUENZA VACCINES

— 21 —

4.0 INFLUENZA VACCINES: PRE-TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

InfluenzaTrivalent Inactivated:Agriflu® Fluviral® Fluzone® Vaxigrip®Influvac® (age ≥18 years)

Quadrivalent Inactivated:Flulaval® Tetra Fluzone® Quad

Trivalent Inactivated, Adjuvanted:Fluad PediatricTM (age 6-23 months)

Yearly 6 months1 Annual

Age 6 months-9 years with previous influenza vaccination: 1 dose

Age 6 months-9 years with no previous influenza vaccination: 2 doses, 4 weeks apart1,2,3,6

Age > 9 years: 1 dose

YES

Quadrivalent vaccine preferred for paediatric patients

NOCovered by MOHLTC for all patients at risk

Live-attenuated Influenza Vaccine (LAIV) quadrivalent:FluMist®

Yearly 2 years1 Annual

Age 2-9 years with previous influenza vaccination: 1 dose

Age 2-9 years with no prior influenza vaccination: 2 doses, 4 weeks apart1,2,3,6


Reserve FluMist® for needle averse patients; less data regarding efficacy in the CKD population

Recommendations may vary across international jurisdictions.

Defer transplant for 2 weeks following vaccine administration to ensure adequate response10, 11

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• The National Advisory Committee on Immunization (NACI) states that administering the most widely used live and inactivated vaccines during the same

patient visit has produced seroconversion rates and rates of adverse reactions similar to those observed when the vaccines are administered separately.1

• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • As a precaution, siblings who have been vaccinated with LAIV should avoid contact with recently transplanted patients who are still in hospital for one week following LAIV dose.9, 27, 31

CONTRAINDICATIONS: • Persons who have developed an anaphylactic reaction to a previous dose of influenza vaccine or any of its components (with the exception of egg*), have developed Guillain-Barre Syndrome (GBS) within 6 weeks of influenza vaccination1

• *egg allergic individuals can be vaccinated with influenza vaccine with inactivated TIV and QIV or LAIV without an influenza skin test and with the full dose of the vaccine.1

— 22 —

REFERENCES:1. National Advisory Committee on Immunization (NACI). ADDENDUM. Advisory committee Statement (ACS).

Canadian Immunization Guide chapter on influenza and statement on seasonal influenza vaccine for 2016-2017: LAIV use in children and adolescents. Accessed November 21, 2016. http://www.phac-aspc.gc.ca/naci-ccni/flu-2016-grippe-addendum-children-enfants-eng.php.

2. National Advisory Committee on Immunization (NACI). Canadian Immunization Guide. Accessed November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.

3. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017 http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf

4. Kumar D, Blumberg EA, Danziger-Isakov L, Kotton CN, Halasa NB, Ison MG, et al. Influenza Vaccination in the Organ Transplant Recipient: Review and Summary of Recommendations. American Journal of Transplantation 2011: 11; 2020-2030.



7. Gavalda J, Cabral E, Perez-Romero P, Len O, Aydillo T, Campins M et al. Immunogenicity of pandemic influenza A H1N1/2009 adjuvanted vaccine in pediatric solid organ transplant recipients. Pediatric Transplantation 2013; 17: 403-406.

8. GiaQuinta S, Michaels MG, McCullers JA, Wang, L, Fonnesbeck C, O’Shea A et al. Randomized, double-blind comparison of standard-dose vs. high-dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients. Pediatric Transplantation 2015; 19: 219-228.








16. Ashkenazi S, Vertruyen A, Aristegui J et al. Superior relative efficacy of live attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. Pediatric Infectious Disease Journal 2006; 25: 870-879.

17. Ohmit SE, Victor JC, Rotthoff JR et al. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. New England Journal of Medicine 2006; 355: 2513-2522.

18. Martin ST, Torabi MJ, Gabardi S. Influenza in solid organ transplant recipients. The Annals of Pharmacotherapy 2012; 46: 255-264.

19. Cordero E, Manuel O. Influenza vaccination in solid-organ transplant recipients. Current Opinion in Organ Transplantation 2012; 17: 601-608.

20. AstraZeneca Canada Inc. Product Monograph FluMist® Quadrivalent June 2016.21. Avery RK. Influenza vaccines in the setting of solid-organ transplantation: are they safe?

Current Opinion in Infectious Diseases 2012; 25: 464-468.22. Moore DL, Canadian Pediatric Society, Infectious Disease and Immunization Committee. Vaccine

recommendations for children and youth for the 2016/2017 influenza season. Accessed November 23, 2016. http://www.cps.ca/en/documents/position/influenza-vaccine-recommendations.

23. Haller W, Buttery J, Laurie K, Beyerle K, Hardikar W, Alex G. Immune response to pandemic H1N1 2009 influenza a vaccination in pediatric liver transplant recipients. Liver Transplantation 2011; 17: 914-920.

24. Danziger-Isakov LA, Husain S, Mooney ML, Hannan MM. The novel 2009 H1N1 influenza virus pandemic: unique considerations for programs in cardiothoracic transplantation. Journal of Heart and Lung Transplantation 2009; 28:1341-1347.

25. Kumar D, Morris MI, Kotton CN, et al. Guidance on novel influenza A/H1N1 in solid organ transplant recipients. American Journal of Transplantation 2010; 10:18-25.

26. Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines. MMWR Recomm Rep 2016; 65:1

27. Kamboj M, Sepkowitz KA. Risk of transmission associated with live attenuated vaccines given to healthy persons caring for or residing with an immunocompromised patient. Infect Control Hosp Epidemiol 2007; 28:702.

28. Sanofi Pasteur Ltd. Product Monograph Fluzone®. February 2014.29. Novartis Pharmaceuticals. Product Monograph Agriflu®. June 2016.30. GlaxoSmithKline Inc. Product Monograph Fluviral®. April 2016.31. American Academy of Paediatrics Committee on Infectious Diseases; Kimberlin DW (ed). RedBook 2015

Report of the Committee on Infectious Diseases 30th edition; 82.

5.0 PRE-TRANSPLANT: TRAVEL VACCINES

— 24 —

REFERENCES:1. Valneva Canada Inc. Dukoral® product monograph 2015.2. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates

and recipients3. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and Medications

for Transplant Travelers 4. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult) 5. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in Immunocompromised

Hosts.” Expert Review of Vaccines 7.5 (2008): 663-72.

6. Abuali M, Arnon R and Posada R. “An Update on Immunizations before and after Transplantation in the Pediatric Solid Organ Transplant Recipient.” Pediatric Transplantation 15.8 (2011): 770-77.

7. Danziger-Isakov, L., and D. Kumar. “Vaccination in Solid Organ Transplantation.” American Journal of Transplantation 13.S4 (2013): 311-17.

8. Patel RP, Liang SY, Koolwal P and Kulhmann FM. “Travel Advice for the Immunocompromised Traveler: Prophylaxis, Vaccination, and Other Preventive Measures.” Therapeutics and Clinical Risk Management TCRM (2015): 217.

9. Bally S, Caillard S and Moulin B. “Prévention Des Pathologies Du Voyageur Chez Le Transplanté Rénal.” Néphrologie & Thérapeutique 5.4 (2009): 265-79.

5.1 ENTEROTOXIGENIC E COLI – PRE-TRANSPLANT TRAVEL GUIDELINES


IN CANADA


MINIMUM INTERVAL PRIOR TO TRAVEL


MINIMUM INTERVAL BETWEEN DOSES

INDICATION PRE-TRANSPLANT

SEROLOGY REQUIRED PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

EnterotoxigenicE coli

Dukoral® (oral, inactivated)

2 years1 2 weeks1

Primary immunization:

2 doses*(1st dose 2 weeks before departure; 2nd dose 1 week following first dose and at least 1 week before departure)

Booster:If 2nd dose of primary series received 3 months- 5 years before:1 dose

1 week1 YES, if indicated2 NO

Not routinely covered by ON-MOHLTC

Cost: $97.11/2 doses

NOTE:*If 6 weeks elapses between doses patient will need to repeat the primary series

— 25 —

5.2 HEPATITIS A – PRE-TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Hepatitis AAVAXIM®AVAXIM®PEDHAVRIX®HAVRIX®JRVAQTA®VAQTA®PED(interchangeable)

IM inj

6 months2 2-4 weeks

Vaccination up until the day of travel may still provide some protection

2

(refer to dosing table below)

6 months

YES, if indicated

Recommended for ALL transplant candidates

NO

Not covered routinely by ON MOHLTC except for high risk* individuals.

Cost:HAVRIX® $37.86HAVRIX®JR $25.14

Combination Hepatitis A VaccinesHep A + Hep BTwinrix®Twinrix Junior®

6 months2

Twinrix®:2 doses (0 and 6-12 months)Twinrix® Junior: 3 doses (0, 1 and 6 months)

YES*

*NACI does not recommend the use of Twinrix® and Twinrix® Jr in patients who are functionally immunosuppressed or hyporesponsive (eg ESRD dialysis patients)2

Not covered routinely by ON MOHLTC.

Cost:Twirix® $67.67Twinrix Junior® $40.07










NOTE:• Comparable to the results reported in clinical trials of children more than 12 months of age, all reviewed studies

have consistently shown that vaccination of infants 6 to 12 months of age with inactivated HA vaccines is immunogenic and safe.

REFERENCES:1. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.2. National Advisory Committee on Immunization. (NACI). Canadian Immunization Guide. Accessed

November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc. 3. CDC. Recommended immunization schedules for persons aged 0 through 18 years - January 2016.


4. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates and recipients.

5. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and Medications for Transplant Travelers.

6. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult). 7. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in

Immunocompromised Hosts.” Expert Review of Vaccines 7.5 (2008): 663-72. 8. Abuali M, Arnon R and Posada R. “An Update on Immunizations. Before and after Transplantation in the

Pediatric Solid Organ Transplant Recipient.” Pediatric Transplantation 15.8 (2011): 770-77. 9. Danziger-Isakov, L., and D. Kumar. “Vaccination in Solid Organ Transplantation.” American Journal of T

ransplantation 13.S4 (2013): 311-17. 10. Patel RP, Liang SY, Koolwal P and Kulhmann FM. “Travel Advice for the Immunocompromised Traveler:

Prophylaxis, Vaccination, and Other Preventive Measures.” Therapeutics and Clinical Risk Management TCRM (2015): 217.


— 26 —

5.3 HEPATITIS B – PRE-TRANSPLANT TRAVEL GUIDELINES


IN CANADA





DOSES



VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Hepatitis BRECOMBIVAX HB®

OR

ENGERIX®-B(interchangeable)

IM inj

For routine schedule refer to Publicly Funded Immunization Schedules for Ontario

Newborn2 Accelerated schedule available given on Days 0, 7, 21 with booster at 6-12 months (upon return from travel)

3 dose schedule preferred (0, 1 and 6 months) if travel not imminent

(Various dosing schedules available, refer to dosing tables below)

7 days after first dose, 14 days after second dose

YES, if indicated

If functionally immunosuppressed (asplenic, hypersplenic), receiving immunosuppressant for underlying condition or hyporesponsive (e.g. ESRD dialysis) consider double the microgram dose for age; use 3 or 4 dose schedule.

Defer transplant for 2 weeks following vaccine administration to ensure adequate response.

YES


Repeat series if antibody response is suboptimal (<10IU/L)

If non-responsive to repeat series, consult ID

Covered under ON MOHLTC school program (grade 7) 2 doses only

Doses 2 and 3 covered for patients i) receiving dialysis or frequent blood products, ii) listed for liver transplant or iii) chronic liver disease

Cost:ENGERIX®-B$64.40

ENGERIX®-B PED$25.14

Twinrix®$67.67

Twinrix Junior®$40.07

Combination Hepatitis A+B

Twinrix®Twinrix Junior®IM

6 months2

Twinrix®2 doses(0 and 6-12 months)

Twinrix Junior®3 doses(0, 1 and 6 months )

NACI does not recommend the use of Twinrix® or Twinrix® Jr in immunosuppressed or hyporesponsive (e.g ESRD dialysis) patients2

TABLE 1: CANADIAN IMMUNIZATION GUIDE (NACI)- HEPATITIS B STANDARD DOSING RECOMMENDATIONS1 FOR PAEDIATIC PATIENTS





5 0.5 0, 1, 6** 10 0.5 0, 1, 6 OR 0, 1, 2, 12

Children 12 months- 19 years

5 0.5 0, 1, 6** 10 0.5 0, 1, 6 OR 0, 1, 2, 12








10 1 0, 1, 6** 20 1 0, 1, 6 OR 0, 1, 2, 12


10 1 0, 1, 6** 20 1 0, 1, 6 OR 0, 1, 2, 12



— 27 —



2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc. 3. CDC. Recommended immunization schedules for persons aged 0 through 18 years - January 2016.




6. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult)

7. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in Immunocompromised Hosts.” Expert Review of Vaccines 7.5 (2008): 663-72.





— 28 —

REFERENCES:1. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates

and recipients.2. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and

Medications for Transplant Travelers.3. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult). 4. Kotton, Camille Nelson. "Vaccination and Immunization against Travel-related Diseases in

Immunocompromised Hosts." Expert Review of Vaccines 7.5 (2008): 663-72.

5. Abuali M, Arnon R and Posada R. "An Update on Immunizations before and after Transplantation in the Pediatric Solid Organ Transplant Recipient." Pediatric Transplantation 15.8 (2011): 770-77.

6. Danziger-Isakov, L., and D. Kumar. "Vaccination in Solid Organ Transplantation." American Journal of Transplantation 13.S4 (2013): 311-17.

7. Patel R, Liang S, Koolwal P and Kulhmann F. "Travel Advice for the Immunocompromised Traveler: Prophylaxis, Vaccination, and Other Preventive Measures." Therapeutics and Clinical Risk Management TCRM (2015): 217.

8. Bally S, Caillard S and Moulin B. "Prévention Des Pathologies Du Voyageur Chez Le Transplanté Rénal." Néphrologie & Thérapeutique 5.4 (2009): 265-79.

5.4 JAPANESE ENCEPHALITIS – PRE-TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Japanese encephalitis

IXIARO®(inactivated)

IM inj

2 months3,5 Consult travel clinic

23

Children younger than 3 years of age receive half of the adult dose

28 days YES, if indicated2,4 NO

Not covered routinely by ON-MOHLTC

Cost: $238.94

— 29 —

REFERENCES:1. The AST Handbook of Transplant Infections: Immunizations after pediatric solid organ transplant

and hematopoetic stem cell transplant (2011).2. NACI: Rabies Vaccine: Immunocompromised persons.3. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates

and recipients.4. NACI: Rabies Vaccine.5. CDC: Rabies Vaccine.6. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and Medications

for Transplant Travelers.7. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult). 8. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in

Immunocompromised Hosts.” Expert Review of Vaccines 7.5 (2008): 663-72.

9. Danziger-Isakov, L., and Kumar, D. “Vaccination in Solid Organ Transplantation.” American Journal of Transplantation 13.S4 (2013): 311-17.

10. Patel R, Liang S, Koolwal P and Kulhmann F. “Travel Advice for the Immunocompromised Traveler: Prophylaxis, Vaccination, and Other Preventive Measures.” Therapeutics and Clinical Risk Management TCRM (2015): 217.


12. Wyplosz B, Van Der Vliet D, Consigny P, Calmus M et al. “Vaccinations Du Voyageur Adulte Transplanté D’organes (à L’exclusion Des Receveurs De Cellules Souches Hématopoïétiques).” Médecine Et Maladies Infectieuses 39.4 (2009): 225-33.

13. Cramer CH, Shleck V, Thomas SE, Kershaw DB et al. “Immune Response to Rabies Vaccination in Pediatric Transplant Patients.” Pediatric Transplantation 12.8 (2008): 874-77.

5.5 RABIES – PRE-TRANSPLANT TRAVEL GUIDELINES


IN CANADA


MINIMUM INTERVAL PRIOR TO

EXPOSURE OR TRAVEL





VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

RabiesIMOVAX® RabAvert® (inactivated vaccine)(can be used interchangeably)

IM1 mL

Newborn1 7 days

Pre-Exposure Prophylaxis:

3 doses Day 0, 7 and 21 or 284

Post-Exposure prophylaxis:Day 0, 3, 7 and 14(immunocompromised patients should receive 5th dose on Day 28)4,5

Pre-Exposure:No; unless immunocompromisedand expecting intense animal exposure or who will be distant from medical care

Post-Exposure Prophylaxis: Yes, if indicated3

Pre Exposure: NO

Post Exposure:Consider serology 7 to 14 days post- completion of series2,3

If titre < 0.5re-vaccinate with 2nd series

Pre-exposure prophylaxis is not routinely covered by ON MOHLTC

Post-exposure immunization is covered by OHIP for exposures in Ontario

Cost: $223.63/dose

Rabies Pasteurized immune globulin IMOGAM® (rabies immune globulin)

Recommended dose of RabIg: 20 IU/kg body weight for all age groups.

Given on Day 0.4

N/A

Whenever possible, the complete complement of vaccines should be administered before transplantation. Vaccines noted to be safe for administration after transplantation may not be sufficiently immunogenic after transplantation.

— 30 —

REFERENCES:1. Sanofi Pasteur Ltd. Product Monograph Typhim Vi®. October 2013.2. NACI: Typhoid-I Vaccine.3. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant

candidates and recipients.4. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and

Medications for Transplant Travelers CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult).

5. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in Immunocompromised Hosts.” Expert Review of Vaccines 7.5 (2008): 663-72.





10. Sanofi Pasteur Ltd. Product Monograph ViVaxim®. September 2015.11. Pax Vax Berna GmbH. Product Monograph Vivotif® January 2015.

5.6 TYPHOID (SALMONELLA TYPHI) - PRE-TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Salmonella Typhi(parenteral inactivated)

TYPHIM Vi®TYPHERIX® IM

2 years1 14 days prior to travel2

1 dose

N/AYes, if indicated3

Re-immunize by IM route every 3 years if ongoing risk1,2,3

Re-immunization by PO route every 7 years if ongoing risk1,2,3

Not required2

Not covered routinely by ON MOHLTC

TYPHIM Vi®Cost: $38.66

Combined Salmonella Typhi and Hepatitis AViVAXIM®(parenteral inactivated)IM

16 years10 14 days1,2

1 dose (booster required for HA with HA vaccine or ViVAXIM®)1 mL IM 0, 6-36 months1,2


Cost: $107.22

Oral, live attenuatedVivotif®

5 years11

7 days follow-ing last dose of capsules

4 enteric-coated capsules taken on alternate days (7-day course)


Cost: $40.12


REFERENCES1. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates

and recipients.2. NACI: Yellow Fever Vaccine.3. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and Medications

for Transplant Travelers.4. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult).5. Danziger-Isakov, L., and D. Kumar. “Vaccination in Solid Organ Transplantation.” American Journal of

Transplantation 13.S4 (2013): 311-17. 6. Patel R, Liang S, Kooolwal P and Kuhlmann F. “Travel Advice for the Immunocompromised Traveler: Prophylaxis,

Vaccination, and Other Preventive Measures.” Therapeutics and Clinical Risk Management TCRM (2015): 217.

7. Wyplosz B, Vand Der Vliet D, Consigny P, Calmus M et al. “Vaccinations Du Voyageur Adulte Transplanté D’organes (à L’exclusion Des Receveurs De Cellules Souches Hématopoïétiques).” Médecine Et Maladies Infectieuses 39.4 (2009): 225-33.

8. Wyplosz B, Burdet C, Francois H, Durrbach J et al. “Persistence of Yellow Fever Vaccine-Induced Antibodies After Solid Organ Transplantation.” American Journal of Transplantation 13.9 (2013): 2458-461.

9. Azevedo L, Lasmar E, Contieri I, Boin L et al. “Yellow Fever Vaccination in Organ Transplanted Patients: Is It Safe? A Multicenter Study.” Transplant Infectious Disease Transpl Infect Dis 14.3 (2011): 237-41. Web.

10. Sanofi Pasteur Limited. YF-Vax® Product Monograph, December 2009.

5.7 YELLOW FEVER – PRE-TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Yellow FeverYF-VAX® (live attenuated)

SC inj

9 months2,10

10 days2,10

(Neutralizing antibodies develop 10 days after vaccination in 80% of immunized persons2)

1 dose2,10 (booster every 10 years)

N/A Yes, if indicated1

For immunocompromised persons, serologic testing should be considered two to five years post-immunization2

Serology may be checked once patient is transplanted

Not routinely covered by MOHLTC

Cost: $164.84

Whenever possible, the complete complement of vaccines should be administered before transplantation.

— 31 —

6.0 POST-TRANSPLANT: INACTIVE VACCINES

— 33 —

6.1 INACTIVE VACCINES: DIPHTHERIA, PERTUSSIS, TETANUS, POLIO AND HAEMOPHILUS INFLUENZA B – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES


POST TRANSPLANTSCHEDULE OR BOOSTER DOSES?

SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

DTaP-IPV-HibPediacel®

Infanrix® IPV/Hib

2,4,6 and 18 months

6 weeks

Doses 1, 2, 3: Minimum interval is 4 weeks

Dose 3 to 4: minimum interval is 6 months butmust be repeated after 12 months1, 2, 4, 7, 9

As per routine schedule

NOT vaccinated or incomplete series Pre-Transplant:Start series 1 year post transplant per ON MOHLTC catch-up schedule.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immuniza-tion_schedule.pdf

May start as early as 4 months post-transplant in special circumstances (consult Transplant Team)

Vaccinated Pre-transplant (Booster):1 year post-transplant DTaP-IPV-Hib (Pediacel®) x 1

4-5 years post-transplant: DTaP-IPV (Quadracel®) x 1(May use Pediacel® if DTaP-IPV vaccines are not available)

NOT done routinely

Covered under MOHLTC

DTaP-IPVQuadracel®

Infanrix®-IPV

4-6 years x 1 dose (May use Pediacel® if DTaP-IPV vaccines are not available)

TdTd Adsorbed®

Boosting every 10 years (adult)

7 years

TdapAdacel®Boostrix®

14-16 years x 1 dose

NOTES:• D = diphtheria toxoid high dose; d = diphtheria toxoid low dose; ap or aP = acellular pertussis; T= tetanus toxoid; IPV or Polio = inactivated polio; Hib = haemophilus influenza type b; HB = hepatitis B• The following vaccines are licensed in Canada but are not part of the Ontario routine immunization schedule and are NOT covered by MOHLTC:

Tdap polio: Adacel-Polio®, Td polio: Td Polio Adsorbed®, TdaP-IPV: Boostrix®-Polio, DTap-HB-IPV-Hib: Infanrix-hexa®• Dose = 0.5 mL

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE: • The National Advisory Committee on Immunization (NACI) states that administering the most widely used live and inactivated vaccines during the same


• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • DTaP-IPV-Hib (Pediacel®) can be given at the same time as other routine vaccinations such as meningococcal C conjugate and hepatitis B as long as it is administered in a separate site.9

— 34 —


2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.3. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice. Vaccination in solid organ

transplantation. American Journal of Transplantation 2013; 13: 311-17.4. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation in the pediatric

solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.5. Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y. Effectiveness and

safety of immunization with live-attenuated and inactivated vaccines for pediatric liver transplantation recipi-ents. Vaccine 2015; 33: 1440-45.

6. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017. http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf



9. Sanofi Pasteur Ltd. Product Monograph-Pediacel®. March 2012. 10. GlaxoSmithKline Inc. Product Monograph-Infanrix®. July 2015.11. Sanofi Pasteur Ltd. Product Monograph-Quadracel®. August 2011. 12. GlaxoSmithKline Inc. Product Monograph-Infanrix-IPV®. September 2014.13. Sanofi Pasteur Ltd. Product Monograph-Td Adsorbed®. October 2012. 14. Sanofi Pasteur Ltd. Product Monograph-Adacel®. June 2012. 15. GlaxoSmithKline Inc. Product Monograph-Boostrix®. August 2013.16. Sanofi Pasteur Ltd. Product Monograph-Adacel®-Polio. July 2013.17. GlaxoSmithKline Inc. Product Monograph-Boostrix®-Polio. August 2013.18. GlaxoSmithKline Inc. Product Monograph-Infanrix-Hexa®. August 2016.

— 35 —

6.2 INACTIVE VACCINES: MENINGOCOCCAL – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Meningococcal group C conjugate vaccine (Men-C-C)NeisVac-C®Menjugate®Meningitec®

HIGH RISK* (1-10 years)

Other children: 12 months

2 months1

Menjugate®: 1 month19

NeisVac-C®/Meningitec®: 2 months20,21

Menjugate®:2-12 months: 3 doses

NeisVac-C®/Meningitec®: 2 -12 months: 2 doses: 2nd dose should be after 5 months age

>12 months: 1 dose

YES

NOT vaccinated or Incomplete Series¥:Start vaccination as early as 6 months post-transplant

6-12 months age:2 doses Men-C-C, 4 weeks apart, then 1 dose Men-C-ACWY at 2 years

>12-24 months:1 dose Men-C-C, then 1 dose Men-C-ACWY at 2 years

>24 months:1 dose Men-C-C, then 4-6 weeks post, 1 dose Men-C-ACWY

Vaccinated Pre-Transplant (Booster)6 months -1 year post transplant: Men-C-ACWY x 1 dose ( ≥ 2 years age)

NOT done routinely

Covered per routine schedule or HIGH RISK* (1-10 years)

NOT covered for high risk( < 12 months)

Cost: $100/dose

Meningococcal quadrivalent ACW-135Y conjugate vaccine (Men-C-ACWY)Menactra®Menveo®Nimenrix®

HIGH RISK* (≥ 2 years)

Other children:Grade 7

Menactra®: 9 months4,8,16

Menveo®: 2 months9,16

Nimenrix®: 12 months18

1 dose only Routine: 1 dose only

High Risk patients > 24 months: 2 doses

Covered under MOHLTC school program (grade 7)

OR

HIGH RISK* (9 months- 55 years of age)

Cost: $100-150/dose

Serogroup B Meningococcal Vaccine (4CMenB)Bexsero®

Dose = 0.5 mL

For HIGH RISK* only (2 months- 17 years)2

2 months 1 month

Age: 2-5 months: 3 doses, 1 month apart then booster at 12-23 months

Age: 6 -11 months: 2 doses, 2 months apart, followed by 3rd dose at 12-23 months AND 2 months after 2nd dose

Age: 12 months-10 years: 2 doses, 2 months apart

Age: 11-17 years: 2 doses, 1 month apart5,13

YES¥

Transplant recipients are considered to be at HIGH RISK due to concurrent immunosuppresion

Covered for HIGH RISK* ONLY

Cost:$200-250/dose

*HIGH RISK: 1. Functional/anatomic asplenia2. Complement, properdin, factor D or primary antibody deficiencies3. Cochlear implants (pre/post implant)4. HIV+, 5. Persons with acquired complement deficiencies due to receipt

of the terminal complement inhibitor eculizumab (Soliris™)1,2

• Increased risk of exposure: travelers where meningococcal vaccine is recommended (meningitis belt of Sub-Saharan Africa) or required (pilgrims to Hajj in Mecca).

• ¥ Expert opinion.

CONTRAINDICATIONS:In persons with history of anaphylaxis after a previous dose of the vaccine and in patients with proven hypersensitivity/anaphylaxis to any component of the vaccine or its container.1




• Men-C-C products, Menactra® and Bexsero® can be given with other routine childhood immunizations, in a different injection site with a separate needle and syringe1. Per NACI, Menveo® administration at the same time as PCV13 requires further study.1 However, the Menveo® product monograph indicates concomitant administration with other routine childhood immunizations is appropriate (separate injection site and syringe).9

REFERENCES:1. NACI. Canadian Immunization Guide. Accessed November 21, 2016 and April 27, 2017.

http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf3. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice.

Vaccination in solid organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation

in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.5. Meningococcal B Pilot Project Task Group. The recommended use of the multicomponent

meningococcal B (4CMenB) vaccine in Canada: common guidance statement. Pan-Canadian Public Health Network. March 26, 2014. Retrieved Feb 8, 2016. http://publications.gc.ca/collections/collection_2014/aspc-phac/HP40-103-2014-eng.pdf.

6. Avery RK, Michaels M. Update on immunizations in solid organ transplant recipients: What clinicians need to know? American Journal of Transplantation 2008; 8: 9-14.

7. Report from the Advisory Committee on Immunization Practices (ACIP): Decision not to recommend routine vaccination of all children aged 2-10 years with quadrivalent meningococcal conjugate vaccine (MCV4). MMWR Morbidity and Mortality Weekly Report 2008; 57: 462-465.

8. Sanofi Pasteur Ltd. Product Monograph-Menactra®. June 2012.9. Novartis Vaccines and Diagnostics Inc. Product Monograph-Menveo™. November 2014. 10. Advisory Committee on Immunization Practices 2011 Immunization schedules.

Available at: http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm.



13. Novartis Vaccines and Diagnostics Inc. Product Monograph-Bexsero™. November 2013.14. Kumar D. Immunizations following solid-organ transplantation. Current Opinion in Infectious Disease 2014;

27: 329-335.15. L’Huillier AG, Kumar D. Immunizations in solid organ and hematopoeitic stem cell transplant patients:

A comprehensive review. Human Vaccines and Immunotherapeutics 2015; 11: 2852-63. 16. CDC. Recommended immunization schedules for persons aged 0 through 18 years - January 2016.


17. Allen UD, Green M. Prevention and treatment of infectious complications after solid organ transplantation in children. Pediatric Clinics of North America 2010; 57(2):459-79.

18. GlaxoSmithKline Inc. Product Monograph-Nimenrix®. June 2015. 19. GlaxoSmithKline Inc. Product Monograph-Menjugate®. December 2015.20. Pfizer Canada Product Monograph-NeisVac-C®. March 2015.21. Nuron Biotech Inc Product Monograph-Meningitec®. September 2013.

— 36 —

— 37 —

6.3 INACTIVE VACCINES: PNEUMOCOCCAL – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Pneumococcal Conjugate Vaccine (PCV)Prevnar® (PC13)

Synflorix® (PC10)Not covered

2, 4, 6 and 15 monthsfor HIGH RISK*

2, 4 and 12 months for other children

6 weeks 8 weeks1,2

3-4 doses for high risk (schedule dependent on age)

<5 yrs: follow MOHLTC schedule for high risk

See Tables 1 and 2 on next page

>5yrs, NOT previously immunized: 2 doses PCV, 4-6 weeks apart¥, then 1 dose PPV (6-8 weeks post PCV) followed by 2nd dose PCV 5 years later

NOT vaccinated or incomplete series Pre-Transplant:Vaccination may start as early as 6 months post-transplant

≤ 5 yrs:Follow MOHLTC high risk schedule < 2 yrs: 3 doses PCV> 2 yrs: 2 doses PCV THEN 1 dose PPV

>5yrs: 2 doses PCV, 2 months apart THEN 1 dose PPV, 6-8 weeks post PCV series

Vaccinated Pre-Transplant (Booster dosing):6 months-1 year post tx: PCV x 1 dose followed by PPV x 1 dose 3-5 years post-transplant

NOT done routinely

Covered by MOHLTC per routine schedule for ≤ 5 yrs age2

Prevnar® only

Pneumococcal Polysaccharide Vaccine (PPV)Pneumovax® 23

2 doses for high risk ≥ 2 years

NOT routine for other children

2 years 2 doses for high risk; minimum 6-8 weeks post conjugate vaccine

≥ 2 years: 1 dose, 6-8 weeks post PCV administration (after completion of age appropriate PCV series)

THEN

2nd dose ≥ 5 years after first dose

2 doses covered by MOHLTC for high risk ≥ 2 years

NOTES:• ¥ Expert Opinion• *NACI guidelines, children aged 2 years to < 5 years of age who are at increased risk of invasive pneumococcal disease (IPD) should receive pneumococcal conjugate vaccine, with pneumococcal polysaccharide vaccine being used

as a booster dose in this age group to increase the serotype coverage. Children at increased risk of IPD include those who attend child care centres, are Aboriginal, have sickle cell disease or other sickle cell hemoglobinopathies, have other types of functional or anatomic asplenia, HIV infection, immunocompromising conditions (e.g., primary immunodeficiencies; malignancies; immunosuppressive therapy, solid organ transplantation, or use of long-term systemic corticosteroids; nephrotic syndrome), chronic medical conditions (e.g., chronic cardiac and pulmonary disease such as bronchopulmonary dysplasia, diabetes mellitus, chronic renal disease or CSF leak) and children with cochlear implants or those receiving cochlear implants1

• Pneumococcal polysaccharide vaccine should be given to all individuals ≥ 5 years of age who have not received the conjugate vaccine previously and who are at higher risk of IPD.1

CONTRAINDICATIONS: • Prevnar® 13: Hypersensitivity to any component of the vaccine, including diphtheria toxoid• Pneumovax® 23: In persons with history of anaphylaxis after a previous dose of the vaccine and in patients with proven hypersensitivity/anaphylaxis to any component of the vaccine or its container.1

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• The National Advisory Committee on Immunization (NACI) states that administering the most widely used live and inactivated vaccines during the same patient visit has produced seroconversion rates

and rates of adverse reactions similar to those observed when the vaccines are administered separately.1


— 38 —

REFERENCES:1. National Advisory Council on Immunization (NACI). Canadian Immunization Guide, 7th Edition. Accessed

November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017.


organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation

in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.5. Pfizer Canada Inc. Product Monograph-Prevnar 13®. December 2015.6. Merck Canada Inc. Product Monograph-Pneumovax®23. July 2016. 7. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.




11. GlaxoSmithKline Inc. Product Monograph-Synflorix®. April 2016.12. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed)


TABLE 1: CHILDREN < 5 YEARS NOT PREVIOUSLY IMMUNIZED WITH THE PNEUMOCOCCAL VACCINE

AGE AT FIRST DOSE APPLIES TO PREVNAR® (PCV13) MINIMUM INTERVALS

6 weeks-6 months High Risk*

Dose 1: age ≥ 6 weeksDose 2: 8 weeks after 1st doseDose 3: 8 weeks after 2nd doseDose 4*: 8 weeks after 3rd dose AND at age ≥ 12 months

7-11 months AllDose 1: Day 0Dose 2: 8 weeks after 1st doseDose 3: 8 weeks after 2nd dose AND at age ≥ 12 months

12-23 months AllDose 1: Day 0Dose 2: 8 weeks after 1st dose


All 1 dose only


** 4 weeks minimal interval between doses with vaccine manufacturers but CIG (NACI) recommends minimal interval to be 8 weeks.

• High risk patients get 4 doses of PCV only if aged 6 weeks to 6 months at first dose.• High risk patients get 2 PPV doses; PPV 1 dose ≥ 8 weeks after last PCV dose and age ≥ 2 years,

2nd dose ≥ 5 years after 1st dose

TABLE 2: CHILDREN < 5 YEARS OF AGE WHO HAVE INTERRUPTED OR INCOMPLETE VACCINATION

CURRENT AGE APPLIES TO

NUMBER OF PCV DOSES PREVIOUSLY RECEIVED

NUMBER OF PCV DOSES REQUIRED TO COMPLETE SERIES

2-6 monthsHigh Risk*

1 Dose

Dose 2: 2 months after 1st doseDose 3: 2 months after 2nd doseDose 4: 2 months after 3rd dose AND at age ≥ 12 months

2 DosesDose 3: 2 months after 2nd doseDose 4: 2 months after 3rd dose AND at age ≥ 12 months

7-11 months All

1 DoseDose 2: 2 months after 1st doseDose 3: 2 months after 2nd dose AND at age ≥ 12 months

2 DosesDose 3: 2 months after 2nd dose AND at age ≥ 12 months

12-23 months All

Dose 1 at age < 12 monthsDose 2: 2 months after 1st doseDose 3: 2 months after 2nd dose

Dose 1 at age ≥ 12 months Dose 2: 2 months after 1st dose

Dose 1 at age < 12 months AND dose 2 at age ≥ 12 months

Dose 3: 2 months after 2nd dose

2 or more doses at age < 12 months1 Dose, 2 months after the most recent dose


All Any incomplete series1 Dose, 2 months after the most recent dose


— 39 —

6.4 INACTIVE VACCINES: HEPATITIS A – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Hepatitis AAvaxim®Avaxim Ped®Havrix®Havrix Jr®Vaqta®Vaqta Ped®(can be used interchangeably)

None 6 months1 6 months2 dose schedule: 0 and 6-12 months*See table 1 for dosing

Recommended for all patients post-transplant, but in particular High Risk*

2 doses (0, 6-12 months)Vaccination may start as early as 6 months post-transplant for High Risk* patients*See table 1 for dosing

Vaccinated pre-transplant (Booster dosing):Consider repeat vaccination for High Risk* based on serology

May be considered in high risk patients who were immunized post-transplant

Covered by ON MOHLTC only for patients with chronic liver disease

Cost: $40-80/dose

Combination Hep A Vaccines:Hep A +B: Twinrix®Twinrix Junior®

NACI does not recommend the use of Twinrix® or Twinrix® Junior in immunosuppressed patients1

High Risk* includes liver transplant recipients, travel to endemic countries, residents in native communities, institutionalized patients












TABLE 2: TWINRIX® DOSING SCHEDULE1


ANTIGEN* mL SCHEDULE (MONTHS) ANTIGEN* mL SCHEDULE (MONTHS)

6 months-15 years

720 ELISA units

1 0, 6-12360 ELISA units

0.5 0, 1, 6

16-18 years - - -360 ELISA units

0.5 0, 1, 6

CONTRAINDICATIONS: • In persons with a history of anaphylaxis after previous administration of a HA-containing vaccine and in persons

with proven immediate or anaphylactic hypersensitivity to any component of the product or its container.11 TWINRIX® and TWINRIX® Junior: latex in plunger stopper of pre-filled syringe, neomycin, yeast.11

CONCOMITANT ADMINISTRATION OF VACCINES LISTED IN THIS TABLE:• The National Advisory Committee on Immunization (NACI) states that administering the most widely used live and

inactivated vaccines during the same patient visit has produced seroconversion rates and rates of adverse reactions similar to those observed when the vaccines are administered separately.1

• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • Since HAVRIX® is an inactivated vaccine, its concomitant use with other inactivated vaccines is unlikely to result in

interference with immune responses. When concomitant administration of other vaccines is considered necessary, the vaccines must be given with different syringes and at different injection sites.10

— 40 —



http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.3. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice.

Vaccination in solid organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.5. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation in the pediatric

solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.6. Kumar D. Immunizations following solid-organ transplantation. Current Opinion in Infectious Disease 2014;

27: 329-335.


8. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed) Red Book: 2015 Report of the Committee on Infectious Diseases (30th edition). Elk Grove Village, IL: American Academy of Pediatrics.


10. GlaxoSmithKline Inc. Product Monograph-Havrix®. March 2016.11. GlaxoSmithKline Inc. Product Monograph-Twinrix®. August 2016. 12. Sanofi Pasteur Ltd. Product Monograph-Avaxim Pediatric®. October 2015.

— 41 —

6.5 INACTIVE VACCINES: HEPATITIS B – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Hepatitis BEngerix®-B

OR

Recombivax HB®(can be used interchangeably)

Grade 7 (12 years)

2 doses(0, 6 months)

Newborn2

Varied accelerated schedules available

ACCELERATED SCHEDULES:4 dose:0, 7, 21-28 days, and booster at 6 months

3 dose:0, 1, > 2 months

3 dose schedule preferred:0, 1, 6 months

Double the microgram dose for age is recommended in transplant patients.*See Table 2 for dosing

May start vaccination 12 months Post-transplant or earlier if required (minimum 6 months post-transplant) for high risk (e.g. travel)

NOT vaccinated or INCOMPLETE Pre-Transplant: 3 dose schedule: 0, 1, 6 months preferred

OR

Accelerated Schedule:4 dose: 0, 7, 21-28 days, and booster at 6 months3 dose: 0, 1, >2 months

Vaccinated Pre-transplant (Boosting)-if seronegative at 1 year post-transplant: repeat series (3-4 doses) x1

YES


Annually post series to assess ongoing immunity

If seronegative, repeat vaccine series x1


Covered byON MOHLTC school program (grade 7) -2 doses only

Covered < 7 years age immigrated from countries of high prevalence or exposed to family carriers

Doses 2 and 3 covered for patients2:-on dialysis or receiving frequent blood products-listed for transplant-chronic liver disease

Combination Hep B Vaccines:Hep A +B: Twinrix®Twinrix Junior®

DTaP-HB-IPV-HibINFANRIX hexa™

NACI does not recommend the use of Twinrix® or Twinrix® Junior in immunosuppressed patients1

TABLE 1: CANADIAN IMMUNIZATION GUIDE (NACI)- HEPATITIS B STANDARD DOSING RECOMMENDATIONS FOR PAEDIATIC PATIENTS





5 0.5 0, 1, 6** 10 0.5 0, 1, 6 OR 0, 1, 2, 12


5 0.5 0, 1, 6** 10 0.5 0, 1, 6 OR 0, 1, 2, 12








10 1 0, 1, 6** 20 1 0, 1, 6 OR 0, 1, 2, 12


10 1 0, 1, 6** 20 1 0, 1, 6 OR 0, 1, 2, 12






• According to the National Advisory Committee on Immunization (NACI), RECOMBIVAX HB® (hepatitis B vaccine [recombinant]) may be administered simultaneously with other vaccines at different sites. A separate needle and syringe should be used for each vaccine.14

CONTRAINDICATIONS:• In persons with a history of anaphylaxis after previous administration of a HB-containing

vaccine and in persons with proven immediate or anaphylactic hypersensitivity to any component of the product or its container.13, 14


November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.2. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017


organ transplantation. American Journal of Transplantation 2013; 13: 311-17.4. European Consesnsus Group on Hepatitis B Immunity. Are booster immunisations needed for lifelong hepatitis

B immunity? Lancet 2000; 355: 561-565.5. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline

for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.6. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation in the

pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.7. Kumar D. Immunizations following solid-organ transplantation. Current Opinion in Infectious Disease 2014;

27: 329-335.8. L’Huillier AG, Kumar D. Immunizations in solid organ and hematopoeitic stem cell transplant patients:

A comprehensive review. Human Vaccines and Immunotherapeutics 2015; 11: 2852-63. 9. Leung DH, Ton-That M, Economides JM, Healy CM. High prevalence of hepatitis B nonimmunity in

vaccinated pediatric liver transplant recipients. American Journal of Transplantation 2015; 15: 535-540. 10. Martin K, Drabble A, Manlhiot C, Dipchand AI. Response to hepatitis A and B vaccination after pediatric

heart transplant. Pediatric Transplantation 2012; 16: 699-703.11. GlaxoSmithKline Inc. Product Monograph-Twinrix®. August 2016. 12. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed) Red

Book: 2015 Report of the Committee on Infectious Diseases (30th edition). Elk Grove Village, IL: American Academy of Pediatrics. 408-412.

13. GlaxoSmithKline Inc. Product Monograph-Engerix B®. September 2015.14. Merck Canada Inc. Product Monograph-Recombivax®. May 2012.

— 42 —

— 43 —



http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf3. Merck Canada Inc. Product Monograph-Gardasil®. February 2015.4. Merck Canada Inc. Product Monograph-Gardasil® 9. December 2016.5. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation in the pediatric

solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.6. CDC. Recommended immunization schedules for persons aged 0 through 18 years-January 2016.


7. GlaxoSmithKline. Product Monograph-Cervarix®. November 2014.

8. American Academy of Pediatrics (AAP) Committee on Infectious Diseases (2015). Kimberlin DW (ed) Red Book: 2015 Report of the Committee on Infectious Diseases (30th edition). Elk Grove Village, IL: American Academy of Pediatrics. 580-582.







6.6 INACTIVE VACCINES: HUMAN PAPILLOMA VIRUS – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Human Papilloma VirusGardasil®(quadrivalent HPV 4 type 6, 11, 16, 18)

Gardasil® 9(9-valent HPV 9 type 6, 11, 16, 18, 31, 33, 45, 52, 58)

Grade 7 females and males

9 years1,2

Gardasil® and Gardasil® 9are approved in females between 9 and 45 years and in males between 9 and 26 years.1,3,4

4 weeks between first and second dose 12 weeks between second and third dose1,2

Third dose at least 24 weeks after first dose1,2

3 doses: 0, 2 and 6 months1,2

If schedule interrupted, series does not need to be restarted5

YES

May be started as soon as 3-6 months post-transplant11

NO

Gardasil® iscovered under ON MOHLTC school program (grade 7) for females and males

Gardasil® 9 will be covered in Ontario once Gardasil® supply depleted

Cost: $180/dose

NOTES:• Dose 0.5 mL IM• Higher incidence of fainting in younger individuals; observe patients for full 15 minutes post dose• Cervarix® (bivalent HPV 2, type 16, 18) is NOT recommended in transplant recipients




• GARDASIL® may be administered concomitantly (at a separate injection site) with Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine], Adacel® [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)], and RECOMBIVAX HB® [hepatitis B vaccine (recombinant)]

• GARDASIL®9 may be administered concomitantly (at a separate injection site) with Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel® [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)], and Repevax* [Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine, (adsorbed, reduced antigen(s) content) (Tdap-IPV)].

7.0 POST-TRANSPLANT: LIVE VACCINES

— 45 —


for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.2. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017.

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf3. Merck Canada Inc. Product Monograph-ProQuad®. June 2015. 4. National Advisory Council on Immunization (NACI) (2006). Canadian Immunization Guide. Accessed

November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc. 5. Danziger-Isakov L, Kumar D. AST Infectious Diseases Community of Practice. Vaccination in

solid organ transplantation. American Journal of Transplantation 2013; (Suppl. 4):311-7.6. Abuali MM, Arnon R, Posada R. An update on immunizations before and after transplantation

in the pediatric solid organ transplant recipient. Pediatric Transplant 2011; 15: 770-7.7. L’Huillier AG, Kumar D. Immunizations in solid organ and hematopoeitic stem cell transplant patients:

A comprehensive review. Human Vaccines and Immunotherapeutics 2015; 11: 2852-63. 8. GlaxoSmithKline Inc. Product Monograph-PRIORIX-TETRA™. October 2014. 9. GlaxoSmithKline Inc. Product Monograph-PRIORIX®. January 2015. 10. Merck Canada Inc. Product Monograph-MMR-II®. June 2015. 11. Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y.


12. Shinjoh M, Hoshino K, Takahashi T, Nakayama T. Updated data on effective and safe immunizations with live-attenuated vaccines for children after living donor liver transplantation. Vaccine 2015; 33: 701-707.






18. Rand EB, McCarthy CA, Whitington PF. Measles vaccination after orthotopic liver transplantation. Journal of Pediatrics 1993; 123:87-9.

19. Kano H, Mizuta K, Sakakihara Y, et al. Efficacy and safety of immunization for pre-and post-liver transplant children. Transplantation 2002; 74:543-50.

20. Khan S, Erlichman J, Rand EB. Live virus immunization after orthotopic liver transplantation. Pediatric Transplant 2006; 10: 78-82.

21. Shinjoh M, Miyairi I, Hoshino K, et al. Effective and safe immunizations with live-attenuated vaccines for children after living donor liver transplantation. Vaccine 2008; 26: 6859-63.

7.1 LIVE VACCINES: MEASLES MUMPS RUBELLA – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Priorix® (MMR)

MMR-II® (MMR)Live vaccines are NOT recommended post organ transplantation.2,3

Recommendations regarding selective use of live vaccines will be made on an individual basis as more data emerges.Priorix-Tetra® (MMR-V)

ProQuad® (MMR-V)3

— 46 —

7.2 LIVE VACCINES: VARICELLA – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Varivax®III (Varicella only)

Varilrix® (Varicella only)Live vaccines are NOT recommended post organ transplantation.1,13,14

Recommendations regarding selective use of live vaccines will be made on an individual basis as more data emerges.Priorix-Tetra® (MMR-V)

ProQuad® (MMR-V)


for vaccination of the immunocompromised host. Clinical Infectious Diseases 2014; 58: e44-100.2. Merck Canada Inc. Product Monograph-ProQuad®. June 2015.3. GlaxoSmithKline Inc. Product Monograph-PRIORIX-TETRA™. October 2014.4. Shinjoh M, Hoshino K, Takahashi T, Nakayama T. Updated data on effective and safe immunizations with

live-attenuated vaccines for children after living donor liver transplantation. Vaccine 2015; 33: 701-707.5. Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y. Effectiveness

and safety of immunization with live-attenuated and inactivated vaccines for pediatric liver transplantation recipients. Vaccine 2015; 33: 1440-45.

6. Posfay-Barbe KM, Pittet LF, Sottas C, Grillet S, Wildhaber BE, Rodriguez M, et al. Varicella-zoster immunization in pediatric liver transplant recipients: safe and immunogenic. American Journal of Transplantation 2012; 12: 2974-85.

7. Pergam SA, Limaye AP, AST Infectious Disease Community of Practice. Varicella zoster virus in solid organ trans-plant recipients. American Journal of Transplantation 2013; 13: 138-146.







14. NACI. Canadian Immunization Guide. Accessed January 26, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.

15. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017. http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf



18. Mizuta K, Urahashi T, Ihara Y, et al. Varicella zoster virus disease after pediatric living donor liver transplantation: is it serious? Transplantation Proceedings 2012; 44:780-783.

19. Pittet LF, Posfay-Barbe KM. Immunization in transplantation: review of the recent literature. Current Opinion in Organ Transplantation 2013; 18: 543-548.

20. Danerseau AM, Robinson JL. Efficacy and safety of measles, mumps, rubella and varicella live viral vaccines in transplant recipients receiving immunosuppressive drugs. World Journal of Pediatrics 2008; 4: 254-258.


22. Zamora I, Simon JM, Da Silva ME, Piqueras AI. Attenuated varicella virus vaccine in children with renal transplants. Pediatric Nephrology 1994; 8:190-2.

23. Weinberg A, Horslen SP, Kaufman SS, et al. Safety and immunogenicity of varicella-zoster virus vaccine in pediatric liver and intestine transplant recipients. American Journal of Transplantation 2006; 6:565-8.

24. Donati M, Zuckerman M, Dhawan A, et al. Response to varicella immunization in pediatric liver transplant recipients. Transplantation 2000; 70:1401-4.

25. Merck Canada Inc. Product Monograph Varivax® III. April 2016.26. Glaxo Smith Kline Inc. Product Monograph Varilix®. October 2014.27. Seward JF, Zhang JX, Maupin TJ, Mascola L, Jumaan AO. Contagiousness of varicella in vaccinated cases:

A household contact study. JAMA 2004; 292: 704-708.

— 47 —

REFERENCES:1. Publicly funded immunization schedules for Ontario-December 2016. Accessed April 27, 2017

http://www.health.gov.on.ca/en/pro/programs/immunization/docs/immunization_schedule.pdf.2. National Advisory Committee on Immunization. (NACI). Canadian Immunization Guide. Accessed

November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.


4. Rotarix® Product Monograph. Glaxo Smith Kline. January 2016.

7.3 LIVE VACCINES: ROTAVIRUS – POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Rotavirus oral vaccineRotarix®

RotaTeq® (not interchangeable)

Rotavirus oral vaccine is a live vaccine and should NOT be given post organ transplantation.1,2,3,4

8.0 POST-TRANSPLANT: INFLUENZA VACCINES

— 49 —

8.0 INFLUENZA VACCINES: POST TRANSPLANT GUIDELINES


IN CANADA




DOSES



SEROLOGY PRE/POST

VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

InfluenzaTrivalent Inactivated:Agriflu® Fluviral® Fluzone® Vaxigrip®Influvac® (age ≥18 years)

Quadrivalent Inactivated:Flulaval® Tetra Fluzone®Quad1

Trivalent Inactivated, Adjuvanted:Fluad PediatricTM (age 6-23 months)1

Yearly 6 months1 Annual

Age 6 months - 9 years with previous influenza vaccination: 1 dose

Age 6 months - 9 years with no previous influenza vaccination: 2 doses, 4 weeks apart1,2,3,6


Annual vaccination recommended.

May start as early as 4 months post-transplant if stable degree of immunosuppression

May consider immunizing as early as 1 month3,8,10,12,13,18,19 post-transplant in the following situations: a) influenza outbreakb) patient transplanted just prior to flu season

Consult ID in an influenza outbreak

NoCovered by MOHLTC for all patients at risk

Live-attenuated Influenza Vaccine (LAIV) quadrivalent:FluMist®

*Intranasal Live attenuated vaccine should NOT be given post-transplant.1,2,3

NOTES:• Concomitant Administration of Vaccines Listed in this Table:• The National Advisory Committee on Immunization (NACI) states that administering the most widely used live and inactivated vaccines during the same


• NACI recommends that vaccines administered simultaneously should be given using separate syringes at separate sites.1 • As a precaution, siblings who have been vaccinated with LAIV should avoid contact with recently transplanted patients who are still in hospital for one week following LAIV dose.9

CONTRAINDICATIONS: • Persons who have developed an anaphylactic reaction to a previous dose of influenza vaccine or any of its components (with the exception of egg*), have developed Guillain-Barre Syndrome (GBS) within 6 weeks of influenza vaccination1 • *egg allergic individuals can be vaccinated with influenza vaccine with inactivated TIV and QIV or LAIV without an influenza skin test and with the full dose of the vaccine.1

REFERENCES:1. National Advisory Committee on Immunization (NACI). ADDENDUM. Advisory committee Statement (ACS).

Canadian Immunization Guide chapter on influenza and statement on seasonal influenza vaccine for 2016-2017: LAIV use in children and adolescents. Accessed November 21, 2016. http://www.phac-aspc.gc.ca/naci-ccni/flu-2016-grippe-addendum-children-enfants-eng.php.

2. National Advisory Committee on Immunization (NACI). Canadian Immunization Guide. Accessed November 21, 2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc.


4. Kumar D, Blumberg EA, Danziger-Isakov L, Kotton CN, Halasa NB, Ison MG, et al. Influenza Vaccination in the Organ Transplant Recipient: Review and Summary of Recommendations. American Journal of Transplantation 2011: 11; 2020-2030.



7. Gavalda J, Cabral E, Perez-Romero P, Len O, Aydillo T, Campins M et al. Immunogenicity of pandemic influenza A H1N1/2009 adjuvanted vaccine in pediatric solid organ transplant recipients. Pediatric Transplantation 2013; 17: 403-406.

8. GiaQuinta S, Michaels MG, McCullers JA, Wang, L, Fonnesbeck C, O’Shea A et al. Randomized, double-blind comparison of standard-dose vs. high-dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients. Pediatric Transplantation 2015; 19: 219-228.



11. Danziger-Isakov L, Kumar D, AST Infectious Diseases Community of Practice. Vaccination in solid organ \transplantation. American Journal of Transplantation 2013; 13: 311-17.





16. Ashkenazi S, Vertruyen A, Aristegui J et al. Superior relative efficacy of live attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. Pediatric Infectious Disease Journal 2006; 25: 870-879.

17. Ohmit SE, Victor JC, Rotthoff JR et al. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. New England Journal of Medicine 2006; 355: 2513-2522.

18. Martin ST, Torabi MJ, Gabardi S. Influenza in solid organ transplant recipients. The Annals of Pharmacotherapy 2012; 46: 255-264.

19. Cordero E, Manuel O. Influenza vaccination in solid-organ transplant recipients. Current Opinion in Organ Transplantation 2012; 17: 601-608.

20. AstraZeneca Canada Inc. Product Monograph FluMist® Quadrivalent June 2016.21. Avery RK. Influenza vaccines in the setting of solid-organ transplantation: are they safe? Current Opinion in

Infectious Diseases 2012; 25: 464-468.22. Moore DL, Canadian Pediatric Society, Infectious Disease and Immunization Committee. Vaccine

recommendations for children and youth for the 2016/2017 influenza season. Accessed November 23, 2016. http://www.cps.ca/en/documents/position/influenza-vaccine-recommendations.

23. Haller W, Buttery J, Laurie K, Beyerle K, Hardikar W, Alex G. Immune response to pandemic H1N1 2009 influenza a vaccination in pediatric liver transplant recipients. Liver Transplantation 2011; 17: 914-920.

24. Danziger-Isakov LA, Husain S, Mooney ML, Hannan MM. The novel 2009 H1N1 influenza virus pandemic: unique considerations for programs in cardiothoracic transplantation. Journal of Heart and Lung T ransplantation 2009; 28:1341-1347.

25. Kumar D, Morris MI, Kotton CN, et al. Guidance on novel influenza A/H1N1 in solid organ transplant recipients. American Journal of Transplantation 2010; 10:18-25.

26. Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines. MMWR Recomm Rep 2016; 65:1.

27. Kamboj M, Sepkowitz KA. Risk of transmission associated with live attenuated vaccines given to healthy persons caring for or residing with an immunocompromised patient. Infect Control Hosp Epidemiol 2007; 28:702.

28. Sanofi Pasteur Ltd. Product Monograph Fluzone®. February 2014.29. Novartis Pharmaceuticals. Product Monograph Agriflu®. June 2016.30. GlaxoSmithKline Inc. Product Monograph Fluviral®. April 2016.31. American Academy of Paediatrics Committee on Infectious Diseases; Kimberlin DW (ed). RedBook 2015

Report of the Committee on Infectious Diseases 30th edition; 82.

— 50 —

9.0 POST-TRANSPLANT: TRAVEL VACCINES

— 52 —

REFERENCES1. Valneva Canada Inc. Dukoral® product monograph 2015.2. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates and

recipients.3. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and Medications

for Transplant Travelers.4. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult).5. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in

Immunocompromised Hosts.” Expert Review of Vaccines 7.5 (2008): 663-72.

6. Abuali M, Arnon R and Posada R. “An Update on Immunizations before and after Transplantation n the Pediatric Solid Organ Transplant Recipient.” Pediatric Transplantation 15.8 (2011): 770-77.




9.1 ENTEROTOXIGENIC E COLI – POST TRANSPLANT TRAVEL GUIDELINES


IN CANADA





INDICATION POST-TRANSPLANT


VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

EnterotoxigenicE coli

Dukoral® (oral, inactivated)

2 years1 2 weeks1

Primary immunization:

2 doses*(1st dose 2 weeks before departure; 2nd dose 1 week following first dose and at least 1 week before departure)

Booster:If 2nd dose of primary series received 3 months- 5 years before: 1 dose

1 week1 YES, if indicated. However an adequate response may not be achieved

NO

Not routinely covered by ON-MOHLTC

Cost: $97.11/ 2 doses

NOTES:*If 6 weeks elapses between doses patient will need to repeat the primary series

— 53 —

9.2 HEPATITIS A – POST TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Hepatitis A

AVAXIM®AVAXIM®PEDHAVRIX®HAVRIX®JRVAQTA®VAQTA®PED(interchangeable)

IM inj

6 months2

2-4 weeks

Vaccination up until the day of travel may still provide some protection

2

(refer to dosing table below) 6 months

YES

Recommended for ALL patients post-transplant

NO

Not routinely covered by ON MOHLTC except for high risk* individuals.

Cost:HAVRIX® $37.86HAVRIX®JR $25.14

Combination Hep A+Hep B VaccineTwinrix®Twinrix® Junior

NACI and CDC do not recommend using Twinrix® or Twinrix Jr® in immunosuppressed patients.2












REFERENCES:1. GlaxoSmithKline Inc. Product Monograph. Havrix® March 2016.2. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ

transplant candidates and recipients.3. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations

and Medications for Transplant Travelers.4. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult).5. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in

Immunocompromised Hosts.” Expert Review of Vaccines 7.5 (2008): 663-72. 6. Abuali M, Arnon R and Posada R. “An Update on Immunizations before and after Transplantation

in the Pediatric Solid Organ Transplant Recipient.” Pediatric Transplantation 15.8 (2011): 770-77. 7. Danziger-Isakov, L., and D. Kumar. “Vaccination in Solid Organ Transplantation.” American Journal of

Transplantation 13.S4 (2013): 311-17. 8. Patel RP, Liang SY, Koolwal P and Kulhmann FM. “Travel Advice for the Immunocompromised Traveler:

Prophylaxis, Vaccination, and Other Preventive Measures.” Therapeutics and Clinical Risk Management TCRM (2015): 217.

9. Bally S, Caillar S and Moulin B. “Prévention Des Pathologies Du Voyageur Chez Le Transplanté Rénal.” Néphrologie & Thérapeutique 5.4 (2009): 265-79.

10. GlaxoSmithKline Inc. Product Monograph. Twinrix®. August 201611. Sanofi Pasteur Ltd. Product Monograph. Avaxim® Pediatric. October 2015

— 54 —

9.3 HEPATITIS B – POST TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Hepatitis B

RECOMBIVAX HB®

OR

ENGERIX®-B(interchangeable)

IM inj

For routine schedule refer to Publicly Funded Immunization Schedules for Ontario

Newborn2

Accelerated schedule available given on Days 0, 7, 21 with booster at 6-12 months (upon return from travel)

3 dose schedule preferred if travel not imminent

(Various dosing schedules available, refer to dosing table below)

7 days after first dose, 14 days after second dose

YES

Double the microgram dose for age is recommended for post-transplant patients(see table below for doses)

May immunize as early as 6 months post-transplant for travel

YES


If immunized pre-transplant, confirm serology post-transplant, prior to travel.

Repeat series if antibody response is suboptimal (<10IU/L)


Covered under ON MOHLTC school program (grade 7) 2 doses only

Doses 2 and 3 covered for patients i) receiving dialysis or frequent blood products, ii) listed for liver transplant or iii) chronic liver disease

Cost:ENGERIX®-B$64.40

ENGERIX®-B PED$25.14

Hepatitis A+B

TWINRIX®TWINRIX Junior®

NACI and CDC do not recommend using Twinrix® or Twinrix Jr® in immunosuppressed patients.2

TABLE 1: CANADIAN IMMUNIZATION GUIDE (NACI)- HEPATITIS B STANDARD DOSING RECOMMENDATIONS FOR PAEDIATIC PATIENTS





5 0.5 0, 1, 6** 10 0.5 0, 1, 6 OR 0, 1, 2, 12


5 0.5 0, 1, 6** 10 0.5 0, 1, 6 OR 0, 1, 2, 12








10 1 0, 1, 6** 20 1 0, 1, 6 OR 0, 1, 2, 12


10 1 0, 1, 6** 20 1 0, 1, 6 OR 0, 1, 2, 12





2016 and April 27, 2017. http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php#toc .3. CDC. Recommended immunization schedules for persons aged 0 through 18 years - January 2016.




6. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult).7. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in Immunocompromised






12. GlaxoSmithKline Inc. Product Monograph Engerix B®. September 201513. Merck Canada Inc. Product Monograph Recombivax®. May 201214. GlaxoSmithKline Inc. Product Monograph Twinrix®. August 2016

— 55 —

— 56 —

REFERENCES:1. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant

candidates and recipients.2. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations

and Medications for Transplant Travelers.3. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult) 4. Kotton C. Vaccination and immunization against travel-related diseases in immunocompromised hosts.

Expert Review of Vaccines 7.5 (2008): 663-72.

5. Abuali M., Arnon R, and Posada R. An update on immunizations before and after transplantation in the pediatric solid organ transplant recipient. Pediatric Transplantation 15.8 (2011): 770-77.

6. Danziger-Isakov, L., and Kumar D. Vaccination in solid organ transplantation. American Journal of Transplantation 13.S4 (2013): 311-17.

7. Patel R, Liang S, Koolwal P, and Kulhmann M. Travel Advice for the immunocompromised traveler: Prophylaxis, vaccination, and other preventive Measures. Therapeutics and Clinical Risk Management TCRM (2015): 217.

8. Bally S, Caillard S, and Moulin B. Prévention des pathologies du voyageur chez le transplanté rénal. Néphrologie & Thérapeutique 5.4 (2009): 265-79.

9.4 JAPANESE ENCEPHALITIS – POST TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Japanese encephalitis

IXIARO®(inactivated)

IM inj

2 months3,5 Consult travel clinic

23

Children younger than 3 years of age receive half of the adult dose

28 days YES, if indicated3,5 NO

Not covered routinely by ON-MOHLTC

Cost:$238.94

— 57 —

REFERENCES:1. The AST Handbook of Transplant Infections: Immunizations after pediatric solid organ transplant

and hematopoetic stem cell transplant (2011).2. NACI: Rabies Vaccine: Immunocompromised persons.3. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates and

recipients.4. NACI: Rabies Vaccine.5. CDC: Rabies Vaccine.6. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and Medications

for Transplant Travelers.7. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult). 8. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in Immunocompromised





12. Wyplosz B, Van Der Viliet D, Consigny P, Calmus Y et al. “Vaccinations Du Voyageur Adulte Transplanté D’organes (à L’exclusion Des Receveurs De Cellules Souches Hématopoïétiques).” Médecine Et Maladies Infectieuses 39.4 (2009): 225-33.

13. Cramer C, Shleck V, Thomas S, Kershaw B et al. “Immune Response to Rabies Vaccination in Pediatric Transplant Patients.” Pediatric Transplantation 12.8 (2008): 874-77.

9.5 RABIES – POST TRANSPLANT TRAVEL GUIDELINES


IN CANADA


MINIMUM INTERVAL PRIOR TO

EXPOSURE/TRAVEL





VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Rabies

IMOVAX® RabAvert® (inactivated vaccine)(can be used interchangeably)

IMInfants/small children: mid lateral aspect of thigh

Older children: deltoid 1 mL

Newborn1 7 days4

Pre-exposure prophylaxis:

3 Doses:Days 0, 7 and 21 or 284

Post-exposure prophylaxis: Days 0, 3, 7 and 14 and 284,5 with RabIg on Day 0

Patients MUST seek medical attention

Yes, if indicated3,6

Pre-exposure rabies vaccination can be started 6-12 months after transplant2 for individuals expecting intense animal exposure or who will be distant from medical care

Recommended post-transplant, only for post-exposure prophylaxis1

Pre Exposure:NO

Post Exposure:Consider serology 7 to 14 days post-comple-tion of series2,3

if titre < 0.5 re-vaccinate with 2nd series

Pre exposure prophylaxis is not routinely covered by ON MOHLTC

Post exposure immunization is covered by OHIP for exposures within Ontario

Cost: $223.63/dose

Rabies Pasteurized immune globulin IMOGAM® (rabies immune globulin)

Recommended dose of RabIg:20 IU/kg body weight for all age groups. Given on Day 0.4

N/A


— 58 —

REFERENCES:1. Sanofi Pasteur Ltd. Product Monograph. Typhim Vi®. October 2013.2. NACI: Typhoid-I Vaccine. 3. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates and

recipients.4. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and Medications

for Transplant Travelers. 5. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult). 6. Kotton, Camille Nelson. “Vaccination and Immunization against Travel-related Diseases in Immunocompromised

Hosts.” Expert Review of Vaccines 7.5 (2008): 663-72. 7. Abuali M, Arnon R and Posada R. “An Update on Immunizations before and after Transplantation in the

Pediatric Solid Organ Transplant Recipient.” Pediatric Transplantation 15.8 (2011): 770-77.




11. Sanofi Pasteur Ltd. Product Monograph ViVaxim®. September 210512. Pax Vax Berna GmbH. Product Monograph Vivotif®. January 2015

9.6 TYPHOID (SALMONELLA TYPHI) – POST TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Salmonella Typhi (parenteral inactivated)

TYPHIM Vi®TYPHERIX® IM

2 years1 14 days prior to travel2

1 dose N/A

Yes, if indicated3, however an adequate response may not be achieved

Re-immunization every 2-3 years if at ongoing risk2 Recommended when indicated for ages >2 years4

Use as indicated for normal hosts.5Not required2


Cost:TYPHIM Vi®$38.66

Combined Salmonella Typhi and Hepatitis A VIVAXIM®IM

16 years11 14 days1

1 dose (booster required for HA with HA vaccine or ViVAXIM®)

1 mL IM 0, 6-36 months 1,2

N/AYes, if indicated3, however an adequate response may not be achieved


Cost: $107.22

Vivotif®(oral, live attenuated)

Contraindicated in transplant population2,3

If indicated, use inactivated vaccine3


— 59 —

REFERENCES:1. NACI: Immunization of Immunocompromised Persons: Vaccination of solid organ transplant candidates and

recipient.2. NACI: Yellow Fever Vaccine. 3. The AST Handbook of Transplant Infections: Recommendations for Travel-related Vaccinations and Medications

for Transplant Travelers.4. CDC Yellow Book: Immunocompromised travelers-severe immunosuppression (non HIV-related; adult). 5. Danziger-Isakov, L., and D. Kumar. “Vaccination in Solid Organ Transplantation.” American Journal

of Transplantation 13.S4 (2013): 311-17. 6. Patel R, Liang S, Koolwal P and Kulhmann F. “Travel Advice for the Immunocompromised Traveler: Prophylaxis,

Vaccination, and Other Preventive Measures.” Therapeutics and Clinical Risk Management TCRM (2015): 217.

7. Wyplosz B, Van Der Viliet D, Consigny P, Calmus Y et al. “Vaccinations Du Voyageur Adulte Transplanté D’organes (à L’exclusion Des Receveurs De Cellules Souches Hématopoïétiques).” Médecine Et Maladies Infectieuses 39.4 (2009): 225-33.

8. Wyplosz B, Burdet C, Durnbach F, Duclos-Vallee J et al.“Persistence of Yellow Fever Vaccine-Induced Antibodies After Solid Organ Transplantation.” American Journal of Transplantation 13.9 (2013): 2458-461.

9. Azevedo L, Lasmar E, Contieri F, Boin I et al. “Yellow Fever Vaccination in Organ Transplanted Patients: Is It Safe? A Multicenter Study.” Transplant Infectious Disease Transpl Infect Dis 14.3 (2011): 237-41.

9.7 YELLOW FEVER – POST TRANSPLANT TRAVEL GUIDELINES


IN CANADA







VACCINATION

COVERAGE IN ONTARIO

AND/OR COST

Yellow Fever

YF-VAX® (live attenuated)

SC inj

This Vaccine is CONTRAINDICATED POST TRANSPLANT

The Transplant and Regenerative Medicine Centre’s 2017 Pre and Post-Transplant Immunization Guidelines were revised by the Immunization Working Group, a subgroup of the TRMC Clinical Practice Committee.

A new section, Travel Vaccines, was created for this edition of the Guidelines.

We would like to recognize the contribution of the following individuals:

PREPARATION:Dr. Upton Allen, MBBS, MSc, FRCPC.

Nadya Nalli, BSc. Phm., ACPR., RPh.

Jaspreet Nijjar, PharmD, RPh.

Lu Xuan (Lisa) Sun, Pharm D, RPh.

REVIEW: Kathryn Breckbill, PMP

Rebecca Casas, RN, BSc.N

Maria De Angelis, MScN, NP-Peds.

Dr. Diane Hebert, MD FRCPC.

Ray Lam, BSc. BScN, MN, ANP, PHC-NP

Dr. Valerie Langlois, MD FRCPC.

Janice Lau, BSc. Phm., PharmD., ACPR., RPh.

Dipti Manchharam, BSc. Pharm, RPh.

Kathy Martin, MN, NP-Pediatrics.

Dr. Chia-Wei Teoh, MB BCh BAO, MRCPI, LRCSI, MSc.

James Tjon, BSPhm, PharmD, RPh.

Angela Williams, RN, MS, PHCNP.

Renee Woo, BSc. Phm. ACPR, RPh.

pre-and post-transplant immunization guidelines · • defer transplant for 2 weeks (if possible)...

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