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Influenza Vaccine Responses

Influenza Vaccine Responses

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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 2014

  2. Inactivated Vaccine Serology Studies • Purpose:Evaluation of anti-HA antibody titers to recent viruses as compared to those of the recommended vaccine viruses in children, adults and older adults who had received trivalent or quadrivalent inactivated vaccine (2013-2014 formulation). • Serum samples:Five panels of sera from adults, 5 panels from older adults and 2 panels from pediatric populations were analyzed from trivalent vaccine trials. One panel of sera each from pediatric, adults and older adult was analyzed from a quadrivalent vaccine trial. Sera were collected prior to and 21-28 days post-vaccination. Most of the panels were pre-screened to avoid sera with low antibody titers. • Methods:Hemagglutination inhibition (HI) assays were used to determine HI titers to recent viruses compared to HI titers of the corresponding vaccine virus. A subset of sera was tested by micro-neutralization assay. The serum panels were distributed to and tested in 6 laboratories. 2

  3. Serum panels used for studies: seasonal trivalent vaccine

  4. Serum panels used for studies: seasonal quadrivalent vaccine 4

  5. A(H1N1)pdm09 Serology 5

  6. Antigens for serology:A(H1N1)pdm09

  7. HI ANTIBODY RESPONSES TO THE A(H1N1)pdm09 COMPONENT (% GMT) Egg-ref virus Egg or cell isolates relative GMT 7

  8. A(H1N1)pdm09-summary Vaccines containing A/California/7/2009 antigens elicited anti-HA antibodies of similar geometric mean HI titers to the vaccine virus and the majority of representative A(H1N1)pdm09 viruses 8

  9. A(H3N2) Serology 9

  10. Antigens for serology:A(H3N2)

  11. HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT:using A/Texas/50/2012 egg-grownvirus as reference Egg-isolates Egg-grown ref. Cell isolates relative GMT 11

  12. HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT:using A/Texas/50/2012 cell-grownvirus as referenceEgg-isolates Cell-grown ref. relative GMT Cell isolates 12

  13. A(H3N2)-summary Vaccines containing A/Texas/50/2012 antigens induced anti-HA antibodies of similar geometric mean HI titers (GMT) to recent egg-propagated A(H3N2) viruses as to the vaccine virus. Reduced GMTs were observed for some recent cell-propagated viruses when compared to titers to the egg-propagated vaccine viruses. 13

  14. Influenza B Serology 14

  15. Antigens for serology:influenza B

  16. HI ANTIBODY RESPONSES TO THE B-Yam COMPONENT (% GMT) Yam-like isolates All Yam-like isolates All Vic-like isolates relative GMT Vic-like isolates 16

  17. HI ANTIBODY RESPONSES TO THE B-Vic COMPONENT of QUADRIVALENT VACCINHE (% GMT) relative GMT 17

  18. B-summary Vaccines containing B/Massachusetts/2/2012 (Yam)antigen elicited anti-HA antibodies of similar geometric mean titers to the vaccine virus and the majority of representative recent Yam-lineage viruses, and as expected,elicited anti-HA antibodies of lower titers to representative recent Vic-lineage viruses. Vaccines containing B/Massachusetts/2/2012and B/Brisbane/60/2008 (Vic) antigens elicited anti-HA antibodies of similar geometric mean titres to the vaccine viruses and the majority of representative recent Yam- and the Vic-lineage viruses. 18

  19. Summary H1N1pdm09 Vaccines containing A/California/7/2009-likeantigens stimulated anti-HA antibodies of geometric mean titers to representative recent A(H1N1)pdm09 viruses that were not significantly reduced as compared to titers against A/California/7/2009-like reference viruses H3N2 Vaccines containing A/Texas/50/2012 antigens induced anti-HA antibodies of similar geometric mean HI titers (GMT) to the recent egg-propagated A(H3N2) viruses, but lower GMTs to some recent cell-propagated viruses, when compared to the egg-propagated vaccine viruses. B Vaccines containing B/Massachusetts/2/2012 (Yam)antigen elicited anti-HA antibodies of similar geometric mean titers to the vaccine virus and the majority of representative recent Yam-lineage viruses, and elicited the antibodies of low titers to the representative recent Vic-lineage viruses. Vaccines containing B/Massachusetts/2/2012and B/Brisbane/60/2008 (Vic) antigens elicited anti-HA antibodies of similar geometric mean titers to the vaccine viruses and the majority of representative recent Yam- and the Vic-lineage viruses. 19