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 27 February 2013. Inactivated Vaccine Serology Studies.

jedidiah
Télécharger la présentation

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 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

More Related