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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 28 February 2012

2 Inactivated Vaccine Serology Studies l Recent A(H1N1)pdm09, A(H3N2) and B isolates were analyzed by using 5 panels of sera from adults, 5 panels from elderly and 2 panels from pediatric populations receiving seasonal trivalent inactivated vaccine (2011- 2012 formulation). l Sera were analyzed for the presence of antibodies to the HA antigens of recent virus isolates –Hemagglutination inhibition (HI) titers for recent isolates were compared to HI titer of the vaccine virus by HI assay –A subset of sera were tested by micro-neutralization assay 2

3 Serum panels used for studies: seasonal trivalent vaccine AUSTRALIAA/California/7/2009 (H1N1pdm09) (NYMC X-181) A/Victoria/210/2009 (H3N2) (NYMC X-187) B/Brisbane/60/2008 (Victoria lineage) CHINA EUROPE JAPAN USA ADULTS OLDER ADULTS CHILDREN (12-60 Mon)) ADULTS OLDER ADULTS ADULTS OLDER ADULTS ADULTS OLDER ADULTS CHILDREN (6-24 Mon) ADULTS OLDER ADULTS A/California/7/2009 (H1N1pdm09)-like A/Victoria/210/2009 (H3N2)-like B/Brisbane/60/2008 (Victoria lineage) A/California/7/2009 (H1N1pdm09) (NYMC X-181) A/Victoria/210/2009 (H3N2) (NYMC X-187) B/Brisbane/60/2008 (Victoria lineage) A/California/7/2009 (H1N1pdm09) (NYMC X-179A) A/Victoria/210/2009 (H3N2) (NYMC X-187) B/Brisbane/60/2008 (Victoria lineage)

4 Antigens for serology: A(H1N1)pdm09 VACCINE VIRUS A/California/7/2009-like REPRESENTATIVE CURRENT VIRUSES A/Cape Town/60/2011 A/Valparaiso/17275/2011 A/Wisconsin/26/2011 cell A/Perth/533/2011 A/St. Petersburg/100/2011 A/Argentina/656/2011 cell A/Florida/27/2011

5 HI ANTIBODY RESPONSES TO THE A(H1N1)pdm09 COMPONENT (% GMT)–Example: Older Adults Trial No. of Sera Virus strain pre- vacc GMT Post-vacc GMT Post-vacc GMT reduction (%) Older Adults EU 24A/California/7/2009534 A/St. Petersburg/100/201151750 A/Cape Town/60/201152429 A/Valparaiso/17217275.201152624 A/Aigentina/656/20115876 Older Adults US 24A/California/7/2009745 A/St. Petersburg/100/201151860 A/Cape Town/60/20117427 A/Valparaiso/17217275.201163522 A/Aigentina/656/201151176 Data from CBER

6 HI ANTIBODY RESPONSES TO THE A(H1N1)pdm09 COMPONENT – SUMMARY OF DATA FROM ALL LABORATORIES relative GMT

7 Antigens for serology: A(H3N2) VACCINE VIRUS A/Perth/16/2009-like REPRESENTATIVE CURRENT VIRUSES A/Victoria/361/2011 egg; group 3 A/Hunan-Yueyanglou/1320/2011cell; group 3 A/Hunan-Suxian/1319/2011cell; group 3 A/Utah/12/2011cell; group 3 A/Chiang Rai/277/2011cell; group 3 A/Kobe/241/2011cell; group 3 A/Bangladesh/5071/2011cell; group 3 A/South Australia/03/2011cell; group 3 A/Guangdong-Jinping/1334/2011cell; group 6 A/Brisbane/299/2011egg; group 6 A/Christchurch/28/2011 egg; group 6 A/Kentucky/5/2011cell; group 6 A/Victoria/362/2011egg; group 6

8 HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT –Example: Older Adults Trial No. of Sera Virus strain pre- vacc GM T Post-vacc GMT Post-vacc GMT reduction (%) Older Adults China 30A/Victoria/210/20091970 A/Brisbane/299/2011124733 A/Christchurch/28/2011321300 A/Kentucky/5/20117987 A/Victoria/361/2011102663 A/Victoria/362/2011123550 All viruses47 Older Adults Australia 20A/Victoria/210/2009846 A/Brisbane/299/201163524 A/Christchurch/28/201162741 A/Kentucky/5/20115785 A/Victoria/361/201151372 A/Victoria/362/201172937 All viruses52 Data from NIBSC

9 HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT – SUMMARY OF DATA FROM ALL LABORATORIES relative GMT

10 HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT –GMT ratio plots Data from NIBSC

11 Antigens for serology: B VACCINE VIRUS B/Brisbane/60/2008 (Vic-lineage) REPRESENTATIVE CURRENT VIRUSES Vic-lineage B/Dominican Republic/5486/2011 B/Hong Kong/767/2011 B/Nevada/3/2011 B/Shanghai-Chongming/1458/2011 B/Chongqing-Yuzhong/1651/2011 B/Cameroon/11V-12080GVF1/2011 B/Tokyo/91107/2011 Yamagata-lineage B/Wisconsin/1/2010 B/Texas/6/2011 B/Jiangsu-Tianning/1470/2011

12 HI ANTIBODY RESPONSES TO THE B COMPONENT –Example: Younger Adults Data from CDC PopulationNAntigen Pre GMTPost GMT AUSTRALIA24B/BRISBANE/60/200830 110 24B/NEVADA/03/20112280 24B/DOMINICAN REPUBLIC/5486/201142143 23B/CHONGQING-YUZHONG/1651/201137165 23B/WISCONSIN/1/201022 41 US24B/BRISBANE/60/200826 196 24B/NEVADA/03/201119147 24B/DOMINICAN REPUBLIC/5486/201144277 24B/CHONGQING-YUZHONG/1651/201144311 24B/WISCONSIN/1/201022 113 JAPAN29B/BRISBANE/60/200829 42 30B/NEVADA/03/20111727 30B/DOMINICAN REPUBLIC/5486/20113862 30B/CHONGQING-YUZHONG/1651/20115073 30B/WISCONSIN/1/201033 37

13 HI ANTIBODY RESPONSES TO THE B COMPONENT - SUMMARY OF DATA FROM ALL LABORATORIES relative GMT

14 Summary l H1N1pdm09 – Representative recent A(H1N1)pdm09 viruses were covered by vaccine containing A/California/7/2009 l H3N2 – Many representative recent (H3N2) viruses showed significant reductions in GMT when tested with sera from recipients of vaccine containing A/Perth/16/2009-like viruses l B – B/VICTORIA/2/87-lineage Representative recent viruses were well covered by current vaccine (B/Brisbane/60/2008) – B/YAMAGATA/16/88-lineage Representative recent viruses were less well covered by the latest vaccine (B/Florida/4/2006-like viruses, 2008/2009 influenza season)

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