1 / 19

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 2014. Inactivated Vaccine Serology Studies.

malory
Download Presentation

Influenza Vaccine Responses

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

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 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

More Related