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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.

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Presentation on theme: "Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory."— 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 22 February 2010

2 Inactivated Vaccine Serology Studies l Sera from vaccine recipients was analyzed for the presence of antibodies to the HA of recent virus isolates –Hemagglutination inhibition (HI) titers for recent isolates compared to HI titer of the vaccine virus l Pandemic H1N1 isolates analyzed using over13 panels of sera from adults, elderly, and pediatric populations receiving pandemic H1N1 inactivated vaccines –Included representative pandemic H1N1 isolates as well as low reactors (determined using post-infection ferret antiserum) l Recent A/H3N2 and B isolates analyzed using 9 panels of sera from adults, elderly and pediatric populations receiving seasonal trivalent inactivated vaccine (2009-2010) –Due to predominance of pandemic H1N1 isolates, antibody response to seasonal H1N1 not analyzed

3 Serum Panels Used for Serology (Seasonal) AUSTRALIA, IAN BARR, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) WHO, AUSTRALIA ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) B/Florida/4/2006 EUROPE, JOHN WOOD, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) NIBSC, ENGLAND ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) B/Brisbane/60/2008 JAPAN, TAKATO ODIGARI, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) ) NIID, JAPAN ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) B/Brisbane/60/2008 USA, STEFAN GRAVENSTEIN, M.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) EASTERN VIRGINIA ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) MEDICAL SCHOOLPEDIATRIC B/Brisbane/60/2008

4 Serum Panels Used for Serology Pandemic A(H1N1) 2009 AUSTRALIA, IAN BARR, PH.D. ADULTS(18-64 Yr.) A/California/07/2009 (X179A) WHO, AUSTRALIA CHILDREN (6 mon-17Yr) CHINA, YUELONG SHU PH.D. ADULTS (18-59) A/California/07/2009 (X179A) BEIJING, CHINA ADOLESCENCE (10-17 Yr) CHILDREN (3-9 Yr) EUROPE, JOHN WOOD, PH.D. ADULTS (18-59) A/California/07/2009 (X179A)* NIBSC, ENGLAND ADOLESCENCE (10-17 Yr) CHILDREN (3-9Yr) USA, Linda Lambert, Ph.D. ADULTS (18-64Yr) A/California/07/2009 (X179A) NIH, USA ELDERLY (> 65 Yr) CHILDREN (6 mon-17Yr) *= Adjuvanted or non-adjuvanted

5 Antigens for Serology (pandemic H1N1) VACCINE STRAIN A/CALIFORNIA/7/2009 NYMC X-179A RECENT VIRUS ISOLATES TESTED A/England/195/2009 A/Guam/2125/2009 A/Kobe/92297/2009 A/Lviv/N6/2009 A/IRAQ/8529/2009 A/Ontario/RV3226/2009 A/South Carolina/18/2009 A/Utah/20/2009 A/Brisbane/59/2007 (IVR-148): Seasonal H1N1 as a control

6 Antigens for serology pandemic A(H1N1) 2009 (by Derek Smith, U of Cambridge) A/California/07/2009 NYMC X-179A

7 Antigens for serology pandemic A(H1N1) 2009 A/England/195/2009 A/Guam/2125/2009 A/Lviv/N6/2009 A/Ontario/RV3226/2009 A/South Carolina/18/2009 A/Kobe/92297/2009 A/Iraq/8529/2009 A/Utah/20/2009

8 EXAMPLE OF HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) COMPONENT CDC, ADULT POPULATION TRIALNO. OF SERA VIRUS STRAIN GMT PRE POST UK 16 A/CALIFORNIA/7/2009 X-179A* A/ENGLAND/195/2009 A/IRAQ/8529/2009 A/SOUTH CAROLINA/18/2009 A/ONTARIO/RV3226/2009 A/BRISBANE/59/2007 (seasonal) 556558556558 293 258 153 129 91 13 US25 A/CALIFORNIA/7/2009 X-179A* A/ENGLAND/195/2009 A/IRAQ/8529/2009 A/SOUTH CAROLINA/18/2009 A/ONTARIO/RV3226/2009 A/BRISBANE/59/2007 (seasonal) 7 5 7 5 6 19 557 589 472 368 399 39 AU16 A/CALIFORNIA/7/2009 X-179A* A/ENGLAND/195/2009 A/IRAQ/8529/2009 A/SOUTH CAROLINA/18/2009 A/ONTARIO/RV3226/2009 A/BRISBANE/59/2007 (seasonal) 8 7 6 5 17 111 78 44 32 34 25

9 EXAMPLE OF HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) COMPONENT CDC, ELDERLY POPULATION TRIALNO. OF SER A VIRUS STRAIN GMT PRE POST US25A/CALIFORNIA/7/2009 X-179A* A/ENGLAND/195/2009 A/IRAQ/8529/2009 A/SOUTH CAROLINA/18/2009 A/ONTARIO/RV3226/2009 A/BRISBANE/59/2007 (seasonal) 17 15 19 13 12 17 264 303 211 143 151 24

10 EXAMPLE OF HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) COMPONENT CDC, CHILDREN POPULATION TRIALNO. OF SERA VIRUS STRAIN GMT PRE POST UK 3-9Y 16 A/CALIFORNIA/7/2009 X-179A* A/ENGLAND/195/2009 A/IRAQ/8529/2009 A/SOUTH CAROLINA/18/2009 A/ONTARIO/RV3226/2009 A/BRISBANE/59/2007 (seasonal) 6 5 6 5 30 945 830 236 199 160 40 UK 10-17Y 16 A/CALIFORNIA/7/2009 X-179A* A/ENGLAND/195/2009 A/IRAQ/8529/2009 A/SOUTH CAROLINA/18/2009 A/ONTARIO/RV3226/2009 A/BRISBANE/59/2007 (seasonal) 7 5 7 5 6 19 538 381 129 84 87 59 US 6M-17Y 25 A/CALIFORNIA/7/2009 X-179A* A/ENGLAND/195/2009 A/IRAQ/8529/2009 A/SOUTH CAROLINA/18/2009 A/ONTARIO/RV3226/2009 A/BRISBANE/59/2007 (seasonal) 8 7 6 5 17 223 243 85 61 42 14

11 SUMMARY OF HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) 2009 COMPONENT

12 Antigens for Serology (H3N2) VACCINE STRAIN A/Brisbane/10/2007 A/Uruguay/716/2007 RECENT VIRUS ISOLATES TESTED A/Wisconsin/15/2009 X183 A/Perth/16/2009 A/Hong Kong/26560/2009 A/Shizuoka/736/2009 A/Philippines/2191/2009 A/Victora/208/2009 A/Hunan-Beihu/1313/09

13 EXAMPLE OF HI ANTIBODY RESPONSES TO H3N2 COMPONENT CDC, ADULT POPULATION TRIALTEST SITE NO. OF SER A VIRUS STRAIN GMT PRE POST UK 24A/URUGUAY/716/07 X-175C * A/VICTORIA/208/2009 A/WISCONSIN/15/2009 X-183 A/HONGKONG/26560/2009 13 15 7 8 233 151 80 110 US 24A/URUGUAY/716/07 X-175C * A/VICTORIA/208/2009 A/WISCONSIN/15/2009 X-183 A/HONGKONG/26560/2009 13 15 7 21 277 82 73 82

14 EXAMPLE OF HI ANTIBODY RESPONSES TO THE H3N2 COMPONENT CBER, ELDERLY POPULATION TRIALTEST SITE NO. OF SER A VIRUS STRAIN GMT PRE POST UK 24A/URUGUAY/716/07 X-175C * A/VICTORIA/208/2009 A/WISCONSIN/15/2009 X-183 A/HONGKONG/26560/2009 A/PHILIPPINES/2191/2009 22 21 9 6 9 190 138 87 25 49 US 24A/URUGUAY/716/07 X-175C * A/VICTORIA/208/2009 A/WISCONSIN/15/2009 X-183 A/HONGKONG/26560/2009 A/PHILIPPINES/2191/2009 12 13 7 6 104 52 12 23

15 EXAMPLE OF HI ANTIBODY RESPONSES TO THE H3N2 COMPONENT CBER, CHILDREN POPULATION TRIALNO. OF SERA VIRUS STRAIN GMT PRE POST PEDIATRIC22A/URUGUAY/716/07 X-175C * A/VICTORIA/208/2009 A/WISCONSIN/15/2009 X-183 A/HONGKONG/26560/2009 A/PHILIPPINES/2191/2009 8766687666 219 85 88 35 55

16 SUMMARY OF HI ANTIBODY RESPONSES TO H3N2 COMPONENT

17 Antigens for Serology (B) VACCINE STRAIN-Vic B/Brisbane/60/2008 RECENT VIRUS ISOLATES TESTED B/Bangladesh/5945/2009 B/Hong Kong/230/2009 B/Laos/1232/2009 B/Philippines/6363/2009 Control viruses B/Florida/4/2006-Yam B/Brisbane/3/2007-Yam B/Bangladesh/3333/2007-Yam

18 EXAMPLE OF HI ANTIBODY RESPONSES TO THE B COMPONENT CBER, ADULT POPULATION TRIALNO. OF SERA VIRUS STRAIN GMT PRE POST UK24B/BRISBANE/60/2008-VIC* B/FLORIDA/4/2006-YAM B/HONG KONG/230/2009-VIC B/BANGLADESH/5945/2009-VIC 8 15 6 13 80 48 60 52 US24B/BRISBANE/60/2008-VIC* B/FLORIDA/4/2006-YAM B/HONG KONG/230/2009-VIC B/BANGLADESH/5945/2009-VIC 55665566 41 17 44 33

19 EXAMPLE OF HI ANTIBODY RESPONSES TO THE B COMPONENT CBER, ELDERLY POPULATION TRIALVIRUS STRAIN GMT PRE POST UK B/BRISBANE/60/2008-VIC* B/FLORIDA/4/2006-YAM B/HONG KONG/230/2009-VIC B/BANGLADESH/5945/2009-VIC 12 14 11 14 53 31 46 42 US B/BRISBANE/60/2008-VIC* B/FLORIDA/4/2006-YAM B/HONG KONG/230/2009-VIC B/BANGLADESH/5945/2009-VIC 65976597 15 9 26 17

20 HI ANTIBODY RESPONSES TO THE B COMPONENT CDC, CHILDREN POPULATION TRIALVIRUS STRAIN GMT PRE POST USB/BRISBANE/60/2008-VIC* B/BANGLADESH/3333/2007-YAM B/BANGLADESH/5945/2009-VIC B/HONG KONG/230/2009-VIC 77767776 60 22 57 35

21 SUMMARY OF HI ANTIBODY RESPONSES TO B COMPONENT

22

23 Conclusions from Human Serology Studies l H1N1 –Representative recent pandemic A(H1N1) virus isolates well covered by vaccine containing A/California/07/2009 l H3N2 –Many recent virus isolates showed significant reductions in GMT when tested with sera from recipients of vaccine containing A/Uruguay/716/2007 l B –B/VICTORIA/2/87-lineage Recent virus isolates were well covered by current vaccine –B/YAMAGATA/16/88-lineage Recent virus isolates were less well covered by current vaccine

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