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Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.

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Presentation on theme: "Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory."— Presentation transcript:

1 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 18 February 2009

2 Serum Panels Used for Serology AUSTRALIA, IAN BARR, PH.D. ADULTS A/Solomon Islands IVR-145 (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/Florida/4/2006 JAPAN, TAKATO ODIGARI, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) ) NIID, JAPAN ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) B/Florida/4/2006 USA, STEFAN GRAVENSTEIN, M.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) EASTERN VIRGINIA ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) MEDICAL SCHOOLPEDIATRIC B/Florida/4/2006

3 Antigens for Serology (H1N1) 8 VACCINE STRAIN A/BRISBANE/59/2007 2B REPRESENTATIVE CURRENT STRAINS A/Brazil/5943/2008 2B A/England/412/2008 2B A/Hiroshima/48/2008-E 2B A/Hiroshima/48/2008-C 2B A/Pennsylvania/8/2008 2B A/Victoria/501/2008 2B A/Hong Kong/1870/2008-E 2C A/Hong Kong/1870/2008-C 2C A/Guam/1/2007 2C A/Shiga/8/2008 2C A/Perth/200/2008 2C

4 HI ANTIBODY RESPONSES TO THE H1N1 ADULT POPULATION (NIBSC) 3 NAntigen% Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 EU24A/Brisbane/59/078391501792 24A/Brazil/5943/2008 2B71793879 24A/England/412/2008 2B838103883 24A/Hiroshima/48/2008-C 2B79783488 24A/Hiroshima/48/2008-E 2B83674483 24A/Hong Kong/1870/2008 2C83795488 24A/Pennsylvania/8/2008 2B67650471 USA24A/Brisbane/59/073115503863 24A/Brazil/5943/2008 2B3112283163 24A/England/412/2008 2B3812342563 24A/Hiroshima/48/2008-C 2B2511302556 24A/Hiroshima/48/2008-E 2B38718044 24A/Hong Kong/1870/2008 2C2511353156 24A/Pennsylvania/8/2008 2B131022650 JP24A/Brisbane/59/072922614675 24A/Brazil/5943/2008 2B171021 42 24A/England/412/2008 2B171025846 24A/Hiroshima/48/2008-C 2B218191338 24A/Hiroshima/48/2008-E 2B217151329 24A/Hong Kong/1870/2008 2C258191333 24A/Pennsylvania/8/2008 2B13611421

5 HI ANTIBODY RESPONSES TO THE H1N1 Elderly POPULATION (NIBSC) 3 NAntigen% Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 EU24A/Brisbane/59/075811561779 24A/Brazil/5943/2008 2B429351754 24A/England/412/2008 2B4213532575 24A/Hiroshima/48/2008-C 2B5011461779 24A/Hiroshima/48/2008-E 2B469361767 24A/Hong Kong/1870/2008 2C4611472171 24A/Pennsylvania/8/2008 2B2915422171 USA24A/Brisbane/59/073310292150 24A/Brazil/5943/2008 2B178151329 24A/England/412/2008 2B211024846 24A/Hiroshima/48/2008-C 2B13818429 24A/Hiroshima/48/2008-E 2B869413 24A/Hong Kong/1870/2008 2C178 421 24A/Pennsylvania/8/2008 2B49151729 JP24A/Brisbane/59/073310281350 24A/Brazil/5943/2008 2B17612421 24A/England/412/2008 2B3811392167 24A/Hiroshima/48/2008-C 2B33824450 24A/Hiroshima/48/2008-E 2B17715821 24A/Hong Kong/1870/2008 2C338251346 24A/Pennsylvania/8/2008 2B21917 38

6 A/Brisbane/59/2007 Vaccine SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Adults) 7

7 A/Brisbane/59/2007 Vaccine SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Elderly) 6

8 A/Brisbane/59/2007 Vaccine SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Pediatric) 7

9 Antigens for Serology (H3N2) 2 VACCINE STRAIN A/Brisbane/10/2007 A/Uruguay/716/2007 REPRESENTATIVE CURRENT STRAINS A/BRISBANE/24/2008 A/Missouri/5/2008 A/Norway/2118/2008 A/Taiwan/471/2008 A/New York/09/2008 A/Tennessee/04/2008 A/Kanagawa/65/2008

10 HI ANTIBODY RESPONSES TO THE H3N2 ADULT POPULATION (CBER) PopulationNAntigen % Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 EU24A/Brisbane/10/200788695092 24A/Uruguay/716/2007926113483 24A/Brisbane/24/200879676479 24A/Missouri/5/200871745863 24A/Taiwan/471/200867635471 JP24A/Brisbane/10/200754625454 24A/Uruguay/716/200742619442 24A/Brisbane/24/200842722850 24A/Missouri/5/200821510425 24A/Taiwan/471/2008257171346 USA24A/Brisbane/10/20075812582983 24A/Uruguay/716/20077516953883 24A/Brisbane/24/20087515903888 24A/Missouri/5/20083818524679 24A/Taiwan/471/20085414402975 9

11 HI ANTIBODY RESPONSES TO THE H3N2 Elderly POPULATION (CBER) PopulationNAntigen % Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 EU24A/Brisbane/10/20077981011388 24A/Uruguay/716/200779121132988 24A/Brisbane/24/20087512982579 24A/Missouri/5/2008589451763 24A/Taiwan/471/2008718491371 JP24A/Brisbane/10/200771740871 24A/Uruguay/716/200767941871 24A/Brisbane/24/200858941875 24A/Missouri/5/200846826463 24A/Taiwan/471/200850724854 USA24A/Brisbane/10/20079271271392 24A/Uruguay/716/200792111352592 24A/Brisbane/24/200888121382592 24A/Missouri/5/2008549362171 24A/Taiwan/471/2008548241354 9

12 A/Brisbane/10/2007-like VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ADULT) 12

13 A/Brisbane/10/2007-like VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ELDERLY) 13

14 A/Brisbane/10/2007-like VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Pediatric) 13

15 Antigens for Serology (B) VACCINE STRAIN-Yam B/Florida/4/2006 B/Brisbane/3/2008 REPRESENTATIVE CURRENT STRAINS B/Indiana/01/2008 B/England/145/2008 B/Bangladesh/3333/2007 B/Cape Town/337/2008 B/Fujian Gulou/1272/2008 B/Brisbane/33/2008 B/England/393/208 B/Tochigi/15/2008 B/Brisbane/60/2008 B/Perth/210/2008 14

16 HI ANTIBODY RESPONSES TO B ADULT POPULATION (Australia) 15 NAntigen % Rise Pre- GMT Post- GMT Pre % > 40 Post % > 40 AUS24B/Brisbane/3/2008-Yam90191664095 24B/Cape Town/337/2008-Yam80221713395 24B/Indiana/1/2008-Yam7016924090 24B/Brisbane/60/2008-Vic3017403555 24B/Perth/210/2008-Vic2028616080 24B/Fujian/Gulou/1272/2008-Vic3020464560 EU24B/Brisbane/3/2008-Yam71131162588 24B/Cape Town/337/2008-Yam831719033100 24B/Indiana/1/2008-Yam791312025100 24B/Brisbane/60/2008-Vic3310261354 24B/Perth/210/2008-Vic4212392967 24B/Fujian/Gulou/1272/2008-Vic2515312588

17 HI ANTIBODY RESPONSES TO THE B COMPONENT ADULT POPULATION (Australia) NAntigen % Rise Pre- GMT Post- GMT Pre % > 40 Post % > 40 US24B/Brisbane/3/2008-Yam426221467100 24B/Cape Town/337/2008-Yam426721471100 24B/Indiana/1/2008-Yam42411386796 24B/Brisbane/60/2008-Vic3825524675 24B/Perth/210/2008-Vic2040696084 24B/Fujian/Gulou/1272/2008-Vic25387367100 JP24B/Brisbane/3/2008-Yam219818596100 24B/Cape Town/337/2008-Yam21691168896 24B/Indiana/1/2008-Yam2139737192 24B/Brisbane/60/2008-Vic423255054 24B/Perth/210/2008-Vic429276367 24B/Fujian/Gulou/1272/2008-Vic829346771

18 HI ANTIBODY RESPONSES TO B Elderly POPULATION (Australia) 15 NAntigen % Ri se Pre- GMT Post- GMT Pre % > 40 Post % > 40 AUS24B/Brisbane/3/2008-Yam452710260100 24B/Cape Town/337/2008-Yam55351066095 24B/Indiana/1/2008-Yam5022774085 24B/Brisbane/60/2008-Vic1511222040 24B/Perth/210/2008-Vic1017263545 24B/Fujian/Gulou/1272/2008-Vic2012212540 EU24B/Brisbane/3/2008-Yam58219846100 24B/Cape Town/337/2008-Yam442210967133 24B/Indiana/1/2008-Yam6313693392 24B/Brisbane/60/2008-Vic2110222142 24B/Perth/210/2008-Vic2114292154 24B/Fujian/Gulou/1272/2008-Vic17122246100

19 HI ANTIBODY RESPONSES TO THE B COMPONENT Elderly POPULATION (Australia) NAntigen % Rise Pre- GMT Post- GMT Pre % > 40 Post % > 40 US24B/Brisbane/3/2008-Yam383911367100 24B/Cape Town/337/2008-Yam504012763100 24B/Indiana/1/2008-Yam4225695092 24B/Brisbane/60/2008-Vic17263854 24B/Perth/210/2008-Vic832465867 24B/Fujian/Gulou/1272/2008-Vic4304467100 JP24B/Brisbane/3/2008-Yam4213492575 24B/Cape Town/337/2008-Yam4213412967 24B/Indiana/1/2008-Yam421036850 24B/Brisbane/60/2008-Vic416234250 24B/Perth/210/2008-Vic1319284654 24B/Fujian/Gulou/1272/2008-Vic820284650

20 B/Florida/4/2006 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ADULT) 18

21 B/Florida/4/2006 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ELDERLY) 19

22 B/Florida/4/2006 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Paediatric) 19

23 Serologic Conclusions Studies with human sera collected after immunization with current vaccines show that: H1N1 –Representative recent viruses were modestly inhibited by HA antibodies to current vaccine strains (A/Brisbane/59/2007-like virus). H3N2 –Representative recent viruses were well inhibited by HA antibodies to current vaccine strain (A/Brisbane/10/2007-like virus). B –B/VICTORIA/2/87-lineage Representative recent viruses were not well inhibited by HA antibodies to current vaccine strain (B/Florida/4/2006-like virus). –B/YAMAGATA/16/88-lineage Representative recent viruses were well inhibited by HA antibodies to the current vaccine strain. 20

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