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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 27 February 2013. Inactivated Vaccine Serology Studies.

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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 27 February 2013

  2. Inactivated Vaccine Serology Studies • Purpose: Evaluation of anti-HA antibodies from children, adults and older adults who had received current trivalent inactivated vaccines (2012-2013 formulation) • Serum samples: Five panels of sera from adults, 5 panels from elderly and 3 panels from pediatric populations were analyzed at 6 laboratories. Sera were collected 21-28 days post-vaccination. The most of the panels were pre-screened to avoid sera with low antibodies titer. • Methods: • Hemagglutination inhibition (HI) titers to recent isolates were compared to HI titer of the vaccine virus by HI assay • A subset of sera was tested by micro-neutralization assay 2

  3. Serum panels used for studies: seasonal trivalent vaccine * two sets: one donated from a US manufacture and the other from US contract with CDC 3

  4. A(H1N1)pdm09 Serology 4

  5. Antigens for serology: VACCINE VIRUS A/California/7/2009 REPRESENTATIVE CURRENT VIRUSES A/Bangladesh/2021/2012 egg A/Gansu-Ganzhou/SWL33/2012 egg A/Gansu-Ganzhou/SWL33/2012 cell A/Stockholm/34/2012 cell A/Chiang Rai/312/2012 cell A/India/2192/2012 cell A/Washington/24/2012 egg 5

  6. HI ANTIBODY RESPONSES TO THE A(H1N1)pdm09 COMPONENT (% GMT) Slide 6 summarizes average geometric mean (GMT) antibody titers of vaccine trials by hemagglutination inhibition (HI) test, indicating that A/California/7/09 antigen stimulated antibodies of similar titers to the vaccine and recent H1N1 viruses. relative GMT 6

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

  8. A(H3N2) Serology 8

  9. Antigens for Serology VACCINE VIRUS • A/Victoria/361/2011 (egg or cell) • REPRESENTATIVE CURRENT VIRUSES • A/Attecoube/gr97/2012 cell -> egg • A/Hawaii/22/2012 egg • A/Hawaii/22/2012 cell • A/Sapporo/125/2012 cell • A/Texas/50/2012 cell • A/Texas/50/2012 egg • A/Ohio/02/2012 cell • A/Delaware/15/2012 cell • A/South Carolina/16/2012 cell • A/Beijing-Xicheng/12423/2012 cell • A/Fujian-Yanping/1394/2012 cell • A/Singapore/22/2012 egg • A/Yamaguchi/30/2012 cell 9

  10. HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT –Example: Paediatric Data from CDC 10

  11. HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT: using A/Victoria/361/2011 egg-grown virus as reference Slide 11 summarizes average GMT titers of vaccine trials by HI test, indicating that vaccines containing A/Victoria/361/2011 antigens induced anti-HA antibodies of reduced geometric mean HI titers to the majority of recent cell-propagated A(H3N2) viruses, including cell-propagated A/Victoria/361/2011 virus. Egg-grown ref. All cell grown Cell-grown A/Vic relative GMT 11

  12. HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT: using A/Victoria/361/2011 cell-grown virus as reference Slide 12 shows the results from the same vaccine trials in slide 11, but the cell-propagated A/Victoria/361 was used as the reference antigen. There were no significant GMT differences between the recent cell-propagated A(H3N2) viruses and cell-propagated A/Victoria/361/2011 virus, indicating that cell-propagated A/Victoria/361/2011 virus and the recent cell-propagated A(H3N2) viruses were antigenically indistinguishable in HI test. Cell-grown ref. All cell grown relative GMT 12

  13. HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT:microneutralisation assays using A/Victoria/361/2011 cell-grown virus as reference egg-grown A/Vic Elderly Population Cell-grown A/Vic. ref. US JAPAN UK % GMT Slide 13 shows the example of antibody responses of vaccine trials by micro-neutralisation test. There were no significant GMT differences between the recent cell-propagated A(H3N2) viruses and cell-propagated A/Victoria/361/2011 virus, indicating that cell-propagated A/Victoria/361/2011 virus and the recent cell-propagated A(H3N2) viruses were antigenically indistinguishable in micro-neutralisation test. 13

  14. A(H3N2)-summary Vaccines containing A/Victoria/361/2011 antigens induced anti-HA antibodies of reduced geometric mean HI titers to the majority of recent cell-propagated A(H3N2) viruses compared to the egg-propagated vaccine viruses. 14

  15. Influenza B Serology 15

  16. Antigens for Serology VACCINE VIRUS (Yamagata-clade 3) B/Wisconsin/1/2010, B/Hubei-Wujiagang/158/2009 or B/Texas/6/2010 REPRESENTATIVE CURRENT VIRUSES Yamagata lineage B/Hyogo/4002/2012 (clade 3) cell B/Heilongjiang-Jiguan/1409/2012 (clade 3) cell B/England/580/2012 (clade 2) cell B/Massachusetts/02/2012 (clade 2) egg B/Massachusetts/02/2012 (clade 2) cell B/New Mexico/04/2012 (clade 2) cell B/Brisbane/36/2012 (clade 2) egg Victoria lineage B/Brisbane/60/2008 egg B/Jiangsu-Tianning/1666/2012 egg B/Jiangsu-Pingjiang/1494/2012 cell B/South Australia/36/2012 egg 16

  17. HI ANTIBODY RESPONSES TO THE B COMPONENT Assays with significant reduction (≥ 50 %) in GMT clade 2 vs clade 3 viruses expected ratio: 5:3 observed ratio: 5:1 18

  18. B-summary Vaccines containing B/Wisconsin/1/2010-like antigens generally induced anti-HA antibodies of similar geometric mean HI titers to vaccine virus and the majority of recent B/Yamagata/16/88 lineage viruses. However, significant reductions in GMT were observed more frequently for some serum panels when testing clade 2 virus as compared to clad 3 viruses. 19

  19. Human Serology Studies-Summary H1N1pdm09 Sera from recipients of vaccine containing A/California/7/2009 antigen reacted well with the majority of representative recent A(H1N1)pdm09 viruses. H3N2 Sera from recipients of vaccine containing egg-grown A/Victoria/361/2011 antigen reacted less well with representative recent cell-propagated A(H3N2) viruses. B B/YAMAGATA/16/88-lineage Sera from recipients of vaccine containing B/Wisconsin/1/2010-like antigen generally reacted well with the majority of representative recent Yamagata lineage viruses, but significant reductions in GMT were more frequent for clade 2 viruses than for clade 3 viruses. B/VICTORIA/2/87-lineage Sera from recipients of vaccine containing B/Yamagata/16/88-lineage antigen reacted less well to recent B/Victoria/2/87-lineage viruses. 20

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