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 22 February 2010

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 ( ) –Due to predominance of pandemic H1N1 isolates, antibody response to seasonal H1N1 not analyzed

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

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

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

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

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

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) 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) 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)

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)

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) 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) 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)

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

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

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/ US 24A/URUGUAY/716/07 X-175C * A/VICTORIA/208/2009 A/WISCONSIN/15/2009 X-183 A/HONGKONG/26560/

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/ US 24A/URUGUAY/716/07 X-175C * A/VICTORIA/208/2009 A/WISCONSIN/15/2009 X-183 A/HONGKONG/26560/2009 A/PHILIPPINES/2191/

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/

SUMMARY OF HI ANTIBODY RESPONSES TO H3N2 COMPONENT

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

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 US24B/BRISBANE/60/2008-VIC* B/FLORIDA/4/2006-YAM B/HONG KONG/230/2009-VIC B/BANGLADESH/5945/2009-VIC

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 US B/BRISBANE/60/2008-VIC* B/FLORIDA/4/2006-YAM B/HONG KONG/230/2009-VIC B/BANGLADESH/5945/2009-VIC

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

SUMMARY OF HI ANTIBODY RESPONSES TO B COMPONENT

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