Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.

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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 l Purpose: Evaluation of anti-HA antibodies from children, adults and older adults who had received current trivalent inactivated vaccines ( formulation) l 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 days post-vaccination. The most of the panels were pre-screened to avoid sera with low antibodies titer. l 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 CHINACHILDREN (12-60M) ADULTS OLDER ADULTS A/Christchurch/16/2010 (H1N1pdm09) (NIB-74xp) A/Victoria/361/2011 (H3N2) (IVR-165) B/Hubei-Wujiagang/158/2009 (NYMC BX-39 JAPANADULTS OLDER ADULTS A/California/7/2009 (H1N1pdm09) (NYMC X-179A) A/Victoria/361/2011 (H3N2) (IVR-165) B/Wisconsin/1/2010 (NYMX BX-41) USA*CHILDREN (6-24M) ADULTS OLDER ADULTS A/California/7/2009 (H1N1pdm09) (NYMC X-179A) A/Victoria/361/2011 (H3N2) (IVR-165) B/Texas/6/2011 EUROPEADULTS OLDER ADULTS A/California/7/2009 (H1N1pdm09) (NYMC X-181) A/Victoria/361/2011 (H3N2) (IVR-165) B/Hubei-Wujiagang/158/2009 (NYMC BX-39 * two sets: one donated from a US manufacture and the other from US contract with CDC

4 A(H1N1)pdm09 Serology

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

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. 6 relative GMT

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

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/125/2012cell A/Texas/50/2012 cell A/Texas/50/2012 egg A/Ohio/02/2012 cell A/Delaware/15/2012 cell A/South Carolina/16/2012cell A/Beijing-Xicheng/12423/2012 cell A/Fujian-Yanping/1394/2012 cell A/Singapore/22/2012 egg A/Yamaguchi/30/2012 cell 9

HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT –Example: Paediatric Trial No. of Sera Virus strain pre- vacc GMT Post-vacc GMT %Post GMT Vs Egg-virus %Post GMT Vs Cell-virus US 20A/Victoria/361/2009 Egg A/Victoria/361/2009 Cell A/Texas/50/2011 Cell A/Hawaii/22/2012 Cell A/Beijing-Xicheng/12423/2012 Cell A/Delaware/15/2012 Cell A/South Carolina/16/ China 20A/Victoria/361/2009 Egg A/Victoria/361/2009 Cell A/Texas/50/2011 Cell A/Hawaii/22/2012 Cell A/Beijing-Xicheng/12423/2012 Cell A/Delaware/15/2012 Cell A/South Carolina/16/ Data from CDC 10

HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT: using A/Victoria/361/2011 egg- grown virus as reference relative GMT Egg-grown ref. All cell grown Cell-grown A/Vic 11 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.

HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT: using A/Victoria/361/2011 cell- grown virus as reference relative GMT Cell-grown ref. All cell grown 12 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.

Elderly Population % GMT HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT: microneutralisation assays using A/Victoria/361/2011 cell-grown virus as reference HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT: microneutralisation assays using A/Victoria/361/2011 cell-grown virus as reference US JAPAN UK 13 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. Cell-grown A/Vic. ref. egg-grown A/Vic

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

Influenza B Serology 15

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/1494/2012cell B/South Australia/36/2012egg 16

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

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

Human Serology Studies-Summary l H1N1pdm09 –Sera from recipients of vaccine containing A/California/7/2009 antigen reacted well with the majority of representative recent A(H1N1)pdm09 viruses. l 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. l 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