influenza vaccine responses
DESCRIPTION
Influenza Vaccine Responses. Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA. Prepared for Vaccines and Related Biological Products Advisory Committee 22 February 2010. Inactivated Vaccine Serology Studies. - PowerPoint PPT PresentationTRANSCRIPT
Influenza Vaccine Responses
Zhiping Ye, M.D., Ph.D.
Division of Viral Products
OVRR/CBER/FDA
Prepared for Vaccines and Related Biological
Products Advisory Committee22 February 2010
Inactivated Vaccine Serology Studies
Sera from vaccine recipients was analyzed for the presence of antibodies to the HA of recent virus isolates
– Hemagglutination inhibition (HI) titers for recent isolates compared to HI titer of the vaccine virus
Pandemic H1N1 isolates analyzed using over13 panels of sera from adults, elderly, and pediatric populations receiving pandemic H1N1 inactivated vaccines
– Included representative pandemic H1N1 isolates as well as low reactors (determined using post-infection ferret antiserum)
Recent A/H3N2 and B isolates analyzed using 9 panels of sera from adults, elderly and pediatric populations receiving seasonal trivalent inactivated vaccine (2009-2010)
– Due to predominance of pandemic H1N1 isolates, antibody response to seasonal H1N1 not analyzed
Serum Panels Used for Serology
(Seasonal)
AUSTRALIA, IAN BARR, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1)
WHO, AUSTRALIA ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2)
B/Florida/4/2006
EUROPE, JOHN WOOD, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1)
NIBSC, ENGLAND ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2)
B/Brisbane/60/2008
JAPAN, TAKATO ODIGARI, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) )
NIID, JAPAN ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2)
B/Brisbane/60/2008
USA, STEFAN GRAVENSTEIN, M.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1)
EASTERN VIRGINIA ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2)
MEDICAL SCHOOL PEDIATRIC B/Brisbane/60/2008
Serum Panels Used for SerologyPandemic A(H1N1) 2009
AUSTRALIA, IAN BARR, PH.D. ADULTS(18-64 Yr.) A/California/07/2009 (X179A)
WHO, AUSTRALIA CHILDREN (6 mon-17Yr)
CHINA, YUELONG SHU PH.D. ADULTS (18-59) A/California/07/2009 (X179A)
BEIJING, CHINA ADOLESCENCE (10-17 Yr)
CHILDREN (3-9 Yr)
EUROPE, JOHN WOOD, PH.D. ADULTS (18-59) A/California/07/2009 (X179A)*
NIBSC, ENGLAND ADOLESCENCE (10-17 Yr)
CHILDREN (3-9Yr)
USA, Linda Lambert, Ph.D. ADULTS (18-64Yr) A/California/07/2009 (X179A)
NIH, USA ELDERLY (> 65 Yr)
CHILDREN (6 mon-17Yr)
*= Adjuvanted or non-adjuvanted
Antigens for Serology (pandemic H1N1)
VACCINE STRAIN
A/CALIFORNIA/7/2009 NYMC X-179A
RECENT VIRUS ISOLATES TESTED
• A/England/195/2009• A/Guam/2125/2009• A/Kobe/92297/2009• A/Lviv/N6/2009• A/IRAQ/8529/2009• A/Ontario/RV3226/2009• A/South Carolina/18/2009• A/Utah/20/2009
• A/Brisbane/59/2007 (IVR-148): Seasonal H1N1 as a control
Antigens for serology pandemic A(H1N1) 2009
(by Derek Smith, U of Cambridge)
A/California/07/2009NYMC X-179A
Antigens for serology pandemic A(H1N1) 2009
A/England/195/2009
A/Guam/2125/2009
A/Lviv/N6/2009
A/Ontario/RV3226/2009
A/South Carolina/18/2009
A/Kobe/92297/2009
A/Iraq/8529/2009
A/Utah/20/2009
EXAMPLE OF HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) COMPONENT
CDC, ADULT POPULATIONTRIAL NO.
OFSERA
VIRUS STRAIN GMT PRE POST
UK
16 A/CALIFORNIA/7/2009 X-179A*A/ENGLAND/195/2009A/IRAQ/8529/2009A/SOUTH CAROLINA/18/2009A/ONTARIO/RV3226/2009A/BRISBANE/59/2007 (seasonal)
556558
2932581531299113
US 25 A/CALIFORNIA/7/2009 X-179A*A/ENGLAND/195/2009A/IRAQ/8529/2009A/SOUTH CAROLINA/18/2009A/ONTARIO/RV3226/2009A/BRISBANE/59/2007 (seasonal)
75756
19
55758947236839939
AU 16 A/CALIFORNIA/7/2009 X-179A*A/ENGLAND/195/2009A/IRAQ/8529/2009A/SOUTH CAROLINA/18/2009A/ONTARIO/RV3226/2009A/BRISBANE/59/2007 (seasonal)
87665
17
1117844323425
EXAMPLE OF HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) COMPONENT
CDC, ELDERLY POPULATION
TRIAL NO.OFSERA
VIRUS STRAIN GMT PRE POST
US 25 A/CALIFORNIA/7/2009 X-179A*A/ENGLAND/195/2009A/IRAQ/8529/2009A/SOUTH CAROLINA/18/2009A/ONTARIO/RV3226/2009A/BRISBANE/59/2007 (seasonal)
171519131217
26430321114315124
EXAMPLE OF HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) COMPONENT
CDC, CHILDREN POPULATIONTRIAL NO.
OFSERA
VIRUS STRAIN GMT PRE POST
UK3-9Y
16 A/CALIFORNIA/7/2009 X-179A*A/ENGLAND/195/2009A/IRAQ/8529/2009A/SOUTH CAROLINA/18/2009A/ONTARIO/RV3226/2009A/BRISBANE/59/2007 (seasonal)
65655
30
94583023619916040
UK 10-17Y
16 A/CALIFORNIA/7/2009 X-179A*A/ENGLAND/195/2009A/IRAQ/8529/2009A/SOUTH CAROLINA/18/2009A/ONTARIO/RV3226/2009A/BRISBANE/59/2007 (seasonal)
75756
19
538381129848759
US 6M-17Y
25 A/CALIFORNIA/7/2009 X-179A*A/ENGLAND/195/2009A/IRAQ/8529/2009A/SOUTH CAROLINA/18/2009A/ONTARIO/RV3226/2009A/BRISBANE/59/2007 (seasonal)
87665
17
22324385614214
SUMMARY OF HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) 2009 COMPONENT
0
25
50
75
100
125
150
X-179A A/ENGLAND A/IRAQ A/ONTARIO A/SC SEASONAL
% p
ost
GM
T
ADULT
ELDERLY
CHILDREN
Antigens for Serology (H3N2)
VACCINE STRAIN
A/Brisbane/10/2007A/Uruguay/716/2007
RECENT VIRUS ISOLATES TESTEDA/Wisconsin/15/2009 X183 A/Perth/16/2009 A/Hong Kong/26560/2009 A/Shizuoka/736/2009A/Philippines/2191/2009 A/Victora/208/2009 A/Hunan-Beihu/1313/09
EXAMPLE OF HI ANTIBODY RESPONSES TO H3N2 COMPONENT
CDC, ADULT POPULATION
TRIAL TESTSITE
NO.OFSERA
VIRUS STRAIN GMT PRE POST
UK 24 A/URUGUAY/716/07 X-175C *A/VICTORIA/208/2009A/WISCONSIN/15/2009 X-183A/HONGKONG/26560/2009
131578
23315180
110
US
24 A/URUGUAY/716/07 X-175C *A/VICTORIA/208/2009A/WISCONSIN/15/2009 X-183A/HONGKONG/26560/2009
13157
21
277827382
EXAMPLE OF HI ANTIBODY RESPONSES TO THE H3N2 COMPONENT
CBER, ELDERLY POPULATION
TRIAL TESTSITE
NO.OFSERA
VIRUS STRAIN GMT PRE POST
UK 24 A/URUGUAY/716/07 X-175C *A/VICTORIA/208/2009A/WISCONSIN/15/2009 X-183A/HONGKONG/26560/2009A/PHILIPPINES/2191/2009
2221969
190138872549
US 24 A/URUGUAY/716/07 X-175C *A/VICTORIA/208/2009A/WISCONSIN/15/2009 X-183A/HONGKONG/26560/2009A/PHILIPPINES/2191/2009
1213766
10452521223
EXAMPLE OF HI ANTIBODY RESPONSES TO THE H3N2 COMPONENT
CBER, CHILDREN POPULATION
TRIAL NO. OFSERA
VIRUS STRAIN GMT PRE POST
PEDIATRIC 22 A/URUGUAY/716/07 X-175C *A/VICTORIA/208/2009A/WISCONSIN/15/2009 X-183A/HONGKONG/26560/2009A/PHILIPPINES/2191/2009
87666
21985883555
SUMMARY OF HI ANTIBODY RESPONSES TO H3N2 COMPONENT
0
10
20
30
40
50
60
70
80
90
100
110
* = In children panel
% P
os
t G
MT
ADULT
ELDERLY
CHILDREN
Antigens for Serology (B)
VACCINE STRAIN-VicB/Brisbane/60/2008
RECENT VIRUS ISOLATES TESTED• B/Bangladesh/5945/2009 • B/Hong Kong/230/2009 • B/Laos/1232/2009 • B/Philippines/6363/2009
Control viruses
• B/Florida/4/2006-Yam• B/Brisbane/3/2007-Yam• B/Bangladesh/3333/2007-Yam
EXAMPLE OF HI ANTIBODY RESPONSES TO THE B COMPONENT
CBER, ADULT POPULATION
TRIAL NO.OFSERA
VIRUS STRAIN GMT PRE POST
UK 24 B/BRISBANE/60/2008-VIC*B/FLORIDA/4/2006-YAMB/HONG KONG/230/2009-VICB/BANGLADESH/5945/2009-VIC
8156
13
80486052
US 24 B/BRISBANE/60/2008-VIC*B/FLORIDA/4/2006-YAMB/HONG KONG/230/2009-VICB/BANGLADESH/5945/2009-VIC
5566
41174433
EXAMPLE OF HI ANTIBODY RESPONSES TO THE B COMPONENT
CBER, ELDERLY POPULATION
TRIAL VIRUS STRAIN GMT PRE POST
UK B/BRISBANE/60/2008-VIC*B/FLORIDA/4/2006-YAMB/HONG KONG/230/2009-VICB/BANGLADESH/5945/2009-VIC
12141114
53314642
US
B/BRISBANE/60/2008-VIC*B/FLORIDA/4/2006-YAMB/HONG KONG/230/2009-VICB/BANGLADESH/5945/2009-VIC
6597
159
2617
HI ANTIBODY RESPONSES TO THE B COMPONENT CDC, CHILDREN POPULATION
TRIAL VIRUS STRAIN GMT PRE POST
US B/BRISBANE/60/2008-VIC* B/BANGLADESH/3333/2007-YAM B/BANGLADESH/5945/2009-VIC B/HONG KONG/230/2009-VIC
77 76
60225735
SUMMARY OF HI ANTIBODY RESPONSES TO B COMPONENT
Victoria-lineage
0102030405060708090
100110
*= In children panel
% P
ost
GM
TADULT
ELDERLY
CHILDREN
SUMMARY OF HI ANTIBODY RESPONSES TO B COMPONENT
Yamagata-lineage
0
10
20
30
40
50
60
70
80
90
100
110
* = In children panel
% P
os
t G
MT
ADULT
ELDERLY
CHILDREN
Conclusions from Human Serology Studies
H1N1– Representative recent pandemic A(H1N1) virus isolates well
covered by vaccine containing A/California/07/2009 H3N2
– Many recent virus isolates showed significant reductions in GMT when tested with sera from recipients of vaccine containing A/Uruguay/716/2007
B– B/VICTORIA/2/87-lineage
• Recent virus isolates were well covered by current vaccine – B/YAMAGATA/16/88-lineage
• Recent virus isolates were less well covered by current vaccine