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 28 February 2014

Inactivated Vaccine Serology Studies l 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 ( formulation). l 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 days post-vaccination. Most of the panels were pre-screened to avoid sera with low antibody titers. l 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

Serum panels used for studies: seasonal trivalent vaccine AUSTRALIAADULTS OLDER ADULTS A/California/7/2009 (H1N1pdm09) (NYMC X-179A) A/Victoria/361/2011 (H3N2) (IVR-165) B/Hubei-Wujiagang/158/2009 (NYMC BX-39) CHINACHILDREN (4Yr) ADULTS OLDER ADULTS A/Christchurch/16/2010 (H1N1pdm09) (NIB-74xp) A/Texas/50/2012 (H3N2) (NYMC X-223A) B/Massachusetts/2/2012 (NYMC BX-51B) EUROPEADULTS OLDER ADULTS A/Christchurch/16/2010 (H1N1pdm09) (NIB-74xp) A/Texas/50/2012 (H3N2) (NYMC X-223) B/Massachusetts/2/2012 EUROPEADULTS OLDER ADULTS A/Brisbane/10/2010 (H1N1pdm09) A/Texas/50/2012 (H3N2) (NYMC X-223A) B/Massachusetts/2/2012 JAPANADULTS OLDER ADULTS A/California/7/2009 (H1N1pdm09) (NYMC X-179A) A/Texas/50/2012 (H3N2) (NYMC X-223) B/Massachusetts/2/2012 (NYMC BX-51B) USA (CDC contract) CHILDREN (1.7Yr)A/California/7/2009 (H1N1pdm09) (NYMC X-179A) A/Texas/50/2012 (H3N2) (NYMC X-223A) B/Massachusetts/2/2012

4 Serum panels used for studies: seasonal quadrivalent vaccine USA (Donated by a US mfr.) CHILDREN (3.5Yr) ADULTS OLDER ADULTS A/California/7/2009 (H1N1pdm09) (NYMC X-179A) A/Texas/50/2012 (H3N2) (NYMC X-223A) B/Massachusetts/2/2012 B/Brisbane/60/2008

5 A(H1N1)pdm09 Serology

Antigens for serology: A(H1N1)pdm09 REFERENCE VIRUS A/California/7/2009 REPRESENTATIVE CURRENT VIRUSES A/New Hampshire/4/2013Egg A/Mississippi/10/2013Egg A/Massachusetts/15/2013Egg A/Sichuan-Wuhou/2259/2013Egg A/Lisbon/137/2013 Cell A/Massachusetts/15/2013 Cell A/Pennsylvania/07/2013 Cell A/Brisbane/205/2013 Cell A/Singapore/GP1796/2013 Cell A/Wakayama/153/2013 Cell

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

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

Antigens for serology: A(H3N2) REFERENCE VIRUS A/Texas/50/2012 egg or cell REPRESENTATIVE CURRENT VIRUSES A/New York/39/2012egg A/New York/39/2012cell A/Utah/07/2013egg A/Utah/07/2013cell A/Almaty/2958/2013Egg A/Massachusetts/11/2013Egg A/Victoria/506/2013Egg A/Jiangxi-Xunyang/1790/2013Cell A/Louisiana/09/2013Cell A/Tokyo/31512/2013Cell =Egg and cell pair

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

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

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

Antigens for serology: influenza B REFERENCE VIRUSES B/Massachusetts/2/2012 egg and cell (Yam) B/Brisbane/60/2008 egg (Vic, quadrivalent vaccine only) REPRESENTATIVE CURRENT VIRUSES Yamagata lineage B/Arizona/8/2013Cell B/Chongqing-Yuzhong/11616/2013Egg B/Lithuania/6935/2013Cell B/Shandong-Mudan/1374/2013Cell B/Guatemala/8/2013Cell B/Hong Kong/315/2013Cell B/Phuket/3073/2013Egg B/Townsville/15/2013Cell B/Osaka/18/2013Cell Victoria lineage B/Brisbane/60/2008Egg B/Texas/2/2013Egg B/Texas/2/2013Cell B/Ghana/1118/2013Cell B/Jiangsu-Tianning/1796/2013egg

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

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

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/2/2012 and 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

Summary l H1N1pdm09 –Vaccines containing A/California/7/2009-like antigens 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 l 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. l 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/2/2012 and 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