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Influenza Vaccine Responses

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.

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Influenza Vaccine Responses

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  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. 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). 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 Inactivated Vaccine Serology Studies 2

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

  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 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/1320/2011 cell; group 3 • A/Hunan-Suxian/1319/2011 cell; group 3 • A/Utah/12/2011 cell; group 3 • A/Chiang Rai/277/2011 cell; group 3 • A/Kobe/241/2011 cell; group 3 • A/Bangladesh/5071/2011 cell; group 3 • A/South Australia/03/2011 cell; group 3 • A/Guangdong-Jinping/1334/2011 cell; group 6 • A/Brisbane/299/2011 egg; group 6 • A/Christchurch/28/2011 egg; group 6 • A/Kentucky/5/2011 cell; group 6 • A/Victoria/362/2011 egg; group 6

  8. HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT –Example: Older Adults 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

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

  14. Summary H1N1pdm09 Representative recent A(H1N1)pdm09 viruses were covered by vaccine containing A/California/7/2009 H3N2 Many representative recent (H3N2) viruses showed significant reductions in GMT when tested with sera from recipients of vaccine containingA/Perth/16/2009-like viruses 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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