the human papillomavirus vaccine new

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Biotech in HPV

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Page 1: The Human Papillomavirus Vaccine New

biotechnology in

medicine

Page 2: The Human Papillomavirus Vaccine New

biotechnologyinvolves using living

systems, organisms, or parts of organisms

to develop technologies or make

products

medicinescience & art of dealing with the maintenance of health and the

prevention, alleviation, or cure of

disease

Page 3: The Human Papillomavirus Vaccine New

biotechnology

killed or weakened viruses & bacteria

medicine

immunization &infectious diseases

Page 4: The Human Papillomavirus Vaccine New

vaccines!

Page 5: The Human Papillomavirus Vaccine New

The Human Papillomavirus

most common sexually transmitted infection

major cause of cervical cancer

genital warts

Page 6: The Human Papillomavirus Vaccine New

What does HPV do to your body,

exactly?

Page 7: The Human Papillomavirus Vaccine New

• typically infects epithelial cells, that’s why warts (plantar & genital)

• transmission via direct contact

• genetic material: circular DNA

• DNA contained in protein capsid without a lipid membrane (more resistant to environmental factors)

Page 8: The Human Papillomavirus Vaccine New

• typically infects epithelial cells, that’s why warts (plantar & genital)

• transmission via direct contact

• genetic material: circular DNA

• DNA contained in protein capsid without a lipid membrane (more resistant to environmental factors)

Page 9: The Human Papillomavirus Vaccine New

Oh okay. So how did HPV vaccine

research start?

Page 10: The Human Papillomavirus Vaccine New

It started with a misconception in the 19th century. what people thought

sexually transmitted agent was what caused cervical cancer

discovery of the truth (1980)German Cancer Research Center HPV is a significant culprit!!!

Page 11: The Human Papillomavirus Vaccine New

Since that discovery, lots of scientists began to explore.

Joe DiPaolo & Jay Donniger (NCI) tumor & DNA research

Mark Schiffman & AECMepidemiological studies

enter the idea to develop a

vaccine

Page 12: The Human Papillomavirus Vaccine New

but previous attempts at vaccines for HPV genital infection

failed HPV has oncogenes, the vaccine has to be safe

Also, how to produce lots of the HPV outer shell that produces antibodies?!?!

Page 13: The Human Papillomavirus Vaccine New

The outer shell of HPV could form particles that resemble the original virus!!!

We’ve got this.

Douglas Lowy

John Schiller

Page 14: The Human Papillomavirus Vaccine New

They could also produce a lot of protective antibodies —

and they won’t be infectious, because they lack the viral genes!!!

Page 15: The Human Papillomavirus Vaccine New

this outer shell of HPV(or capsid) is made up of distinctive proteins called

L1 PROTEINS

Page 16: The Human Papillomavirus Vaccine New

Ok, I’m going to use their research together with molecular biology!

Ian Frazer In Queensland, Australia

Page 17: The Human Papillomavirus Vaccine New

Ian Frazer & Jiao Zhou

• clone VLPs

• add to separate “template virus”

• Gardasil (Merck)

Page 18: The Human Papillomavirus Vaccine New
Page 19: The Human Papillomavirus Vaccine New

• L1 proteins produced by separate fermentations

• growth of S. cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates

• VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods.

Page 20: The Human Papillomavirus Vaccine New
Page 21: The Human Papillomavirus Vaccine New

• Cervarix contains purified L1 proteins for HPV 16 & 18

• made possible by recombinant DNA technology

• they are made by cells into which a gene (DNA) has been introduced

Page 22: The Human Papillomavirus Vaccine New

vaccine is made using an “adjuvant system”

ADJUVANT substance that enhances the body's immune response to an antigen

IMMUNOMODULATORS medications used to help regulate or normalize the immune system

MPL (a purified lipid) extracted from bacteria

Page 23: The Human Papillomavirus Vaccine New

The vaccine is adsorbed

virus-like particles and MPL are fixed onto an aluminum compound (stimulates better immune response)

Page 24: The Human Papillomavirus Vaccine New

COMPANY

PROCESS

COVERAGE

COST

Merck

Fermentation

HPV 6, 11, 16, 18

£86.50

GlaxoSmithKline

Adjuvant System

HPV 16, 18

£80.50

Page 25: The Human Papillomavirus Vaccine New

THE HUMAN PAPILLOMAVIRUS

HPV vaccine coverage• cervical cancer• vaginal cancer• vulvar cancer• anal cancer

}women

Page 26: The Human Papillomavirus Vaccine New

THE HUMAN PAPILLOMAVIRUS

Dosage & Administration3 dose series

• 1st dose NOW

• 2nd dose 1-2 months after the first

• 3rd dose 6 months after the first

Recommended for

• girls & boys

• 11 to 12 years of age

• may be given starting age 9

Page 27: The Human Papillomavirus Vaccine New

THE HUMAN PAPILLOMAVIRUS

Dosage & AdministrationCatch-Up Vaccination

• females aged 13-26

• males aged 13-21

Remark

The HPV vaccine may be administered with other vaccines.

Page 28: The Human Papillomavirus Vaccine New

THE HUMAN PAPILLOMAVIRUS

Cervarix VS GardasilCervarix

• GlaxoSmithKline

• blocks HPV 16 and 18

• preferred by the UK Government

Gardasil

• Merck

• blocks HPV 16 and 18, 6 and 11 (genital warts that are more or less harmless)

Page 29: The Human Papillomavirus Vaccine New

issues

THE HUMAN PAPILLOMAVIRUS

Between June 1, 2006 and December 31, 2008

• 12,424 reported adverse events regarding Gardasil Vaccination

• 32 deaths

• Girls in the average age of 18 years old out of the 32 deaths died in the range of 2-405 days after their last Gardasil injection.

Page 30: The Human Papillomavirus Vaccine New

issues

THE HUMAN PAPILLOMAVIRUS

Between May 2009 and September 2010

• 16 additional deaths after Gardasil vaccination

• 789 reports of “serious” Gardasil adverse reactions

• 213 cases of permanent disability

• 25 diagnosed cases of Guillain-Barre Syndrome

Page 31: The Human Papillomavirus Vaccine New

issues

THE HUMAN PAPILLOMAVIRUSBetween September 1, 2010 and

September 15, 2011

• 26 more deaths were recorded due to HPV vaccinations

May 13, 2013

• VAERS (Vaccine Adverse Event Reporting System) received 29, 686 reports of adverse events regarding HPV vaccinations

• Out of 29,686 reports, 136 deaths were reported, 922 reports of permanent disability and 550 life-threatening adverse events

Page 32: The Human Papillomavirus Vaccine New

issues

THE HUMAN PAPILLOMAVIRUS

Page 33: The Human Papillomavirus Vaccine New
Page 34: The Human Papillomavirus Vaccine New

sources

Gallagher, Paul. "Thousands of Teenage Girls Report Feeling Seriously Ill after Routine SchoolCancer Vaccination." The Independent. Independent Digital News and Media, 15 July2015. Web. 31 Oct. 2015. Mercola, Joseph. "HPV Vaccine Is Associated with Serious Health Risks." Mercola.com. 16 July2013. Web. 31 Oct. 2015.

Miranda, Débora. "How Do You Choose the Best Vaccination against Cervical Cancer?" The Guardian. The

Guardian, 20 May 2011. Web. 3 Nov. 2015. "Basics." Basics. U.S. Department of Health and Human Services, n.d. Web. 02 Nov. 2015. "HPV (Human Papillomavirus) Gardasil® VIS." Centers for Disease Control and Prevention.Centers for Disease Control and Prevention, 18 June 2013. Web. 02 Nov. 2015. "HPV Vaccine for Human Papillomavirus -Preteen-Teen-Adolescent." Vaccines. U.S.Department of Health and Human Services, n.d. Web. 02 Nov. 2015. "HPV Vaccine Information for Clinicians - Fact Sheet." Centers for Disease Control andPrevention. Centers for Disease Control and Prevention, 8 July 2012. Web. 02 Nov.2015. "Preventing Cervical Cancer: The Development of HPV Vaccines." National Cancer Institute.N.p., 3 Apr. 2014. Web. 31 Oct. 2015. "What Is a Vaccination and How Does It Work?" Public Health Agency of Canada.Public Health Agency of Canada, 20 Jan. 2014. Web. 02 Nov. 2015.

Page 35: The Human Papillomavirus Vaccine New

sources

"Definitions of Biotechnology." Biotechnology Learning Hub. The University of Waikato, 1 Feb. 2010. Web. 6 Nov. 2015.

F. Y., Liew. "Biotechnology of Vaccine Development." 8 (n.d.): 2-95. The University of Nottingham. The University ofNottingham. Web. 6 Nov. 2015.

"HPV Infection." Canada. MediResource, Inc., n.d. Web. 05 Nov. 2015.

"Human Papilloma Virus (HPV)." Clinuvel. Clinuvel Pharmaceuticals Ltd, n.d. Web. 6 Nov. 2015.

Mapstone, Naomi. "Ian Frazer and Jian Zhou — Inventors of the HPV Vaccine." Financial Times Pearson, 11 June 2015. Web. 6 Nov.

2015.

"Professor Ian Frazer." Throat Cancer Foundation. Throat Cancer Foundation, n.d. Web. 05 Nov. 2015.

Garcon, N., P. Chomez, and M. Van Mechelen. "GlaxoSmithKline Adjuvant Systems in Vaccines: Concepts, Achievements and

Perspectives." National Center for Biotechnology Information. U.S. National Library of Medicine, Oct. 2007. Web. 05 Nov.

2015.

Schwarz, Tino F. "Clinical Update of the AS04-Adjuvanted Human Papillomavirus-16/18 Cervical Cancer Vaccine, Cervarix®.“

Advances in Therapy Adv Therapy 26.11 (2009): 983-98. European Medicines Agency. European Medicines Agency, Nov.

2014. Web. 6 Nov. 2015.

"Immunomodulators Defined | AAAAI." American Academy of Allergy Asthma & Immunology. American Academy of Allergy Asthma &

Immunology, n.d. Web. 05 Nov. 2015.

"Ian Frazer | Biography - Australian Immunologist." Encyclopedia Britannica Online. Encyclopedia Britannica, n.d. Web. 05 Nov. 2015.

Miranda, Debora. "How Do You Choose the Best Vaccination against Cervical Cancer?" The Guardian. Guardian News and Media

Limited, 20 May 2011. Web. 6 Nov. 2015.

Highlights of Prescribing Information. N.d. Gardasil Package Insert.