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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 25 February 2011.

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Influenza Vaccine Responses


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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

25 February 2011

slide2
Recent A(H1N1)pdm09, A(H3N2) and B isolates were analyzed by using 12 panels of sera from adults, elderly and pediatric populations receiving seasonal trivalent inactivated vaccine (2010-2011 formulation).

Sera were analyzed for the presence of antibodies to the HA antigens of recent virus isolates

Hemagglutination inhibition (HI) titers for recent isolates were compared to HI titer of the vaccine virus by HI assay

A subset of sera were tested by micro-neutralization assay

Inactivated Vaccine Serology Studies

2

serum panels used for studies seasonal trivalent vaccine

AUSTRALIA

ADULTS

OLDER ADULTS

A/California/7/2009 (H1N1pdm) (NYMC X-179A)A/Victoria/210/2009 (H3N2) (NYMC X-187)B/Brisbane/60/2008

A/California/7/2009 (H1N1pdm) (NYMC X-179A)A/Victoria/210/2009 (H3N2) (NYMC X-187)B/Brisbane/60/2008

CHINA

CHILDREN

ADULTS

OLDER ADULTS

EUROPE

ADULTS

OLDER ADULTS

A/California/7/2009 (H1N1pdm) (NYMC X-181)A/Victoria/210/2009 (H3N2) (NYMC X-187)B/Brisbane/60/2008 BX-35

A/California/7/2009 (H1N1pdm) (NYMC X-179A)A/Victoria/210/2009 (H3N2) (NYMC X-187)B/Brisbane/60/2008

JAPAN

ADULTS

OLDER ADULTS

USA

CHILDREN

ADULTS

OLDER ADULTS

A/California/7/2009 (H1N1pdm) (NYMC X-179A)A/Victoria/210/2009 (H3N2) (NYMC X-187)B/Brisbane/60/2008

3

Serum panels used for studies:seasonal trivalent vaccine 
antigenic cartography of a h1n1 pdm09 isolates

This slide shows the antigenic map generated from HI data using ferret sera and H1N1 viruses. Viruses are represented as circles, antisera as squares. Vaccine strain are represented by the larger dot, other strains are coloured by antigenic cluster. Grid indicates 1 unit of antigenic distance, a 2-fold dilution in HI titer.

5

Antigenic cartography of A(H1N1)pdm09 isolates
antigens for serology pandemic a h1n1 2011
Antigens for serology:pandemic A(H1N1) 2011

VACCINE VIRUSES

A/California/07/2009 (wt, X-179A and X-181)

REPRESENTATIVE CURRENT VIRUSES

  • A/Christchurch/16/2010n125d, d94n v250a
  • A/Kentucky/9/2010* g155e
  • A/Milano/3/2010 (MDCK cell)
  • A/Brisbane/10/2010 n125d
  • A/Wisconsin/08/2010 s183p
  • A/Sichuan/SWL-1/2009 l32i
  • A/Shanghai-Changning/SWL1700/2010 e374k q223r
  • A/Victoria/663/2010
  • A/Perth/219/2010 s185t, s451n
  • A/Sri Lanka/21/2010
  • A/Brisbane/59/2007 [former seasonal A(H1N1)]

6

hi antibody responses to the pandemic a h1n1 2010 11 component gmt
HI ANTIBODY RESPONSES TO THE PANDEMIC A(H1N1) 2010-11 COMPONENT (% GMT)

This slide summarizes average geometric mean antibody titers of vaccine trials by HI test, indicating that A/California/7/09 antigen stimulated antibodies of similar titers to the vaccine and recent H1N1 viruses.

relative GMT

7

summary of a h3n2 cartography
Summary of A(H3N2) cartography

A

Green=Vic/208 clade

This slide shows the antigenic map generated from HI data using ferret sera and H3N2 viruses. Viruses are represented as circles, antisera as squares. Vaccine strains are represented by the larger dots, other strains are coloured by antigenic cluster. Grid indicates 1 unit of antigenic distance, a 2-fold dilution in HI titer.

9

antigens for serology a h3n2 2011
Antigens for serology:A (H3N2) 2011

VACCINE VIRUSES

A/Perth/16/2009-like (wt and X-187)

REPRESENTATIVE CURRENT VIRUSES

A/Rhode Island/1/2010 d53n, y94h, i230v, e280a

A/Victoria/563/2010d53n, y94h, i230v, e280a

A/Perth/10/2010d53n, y94h, i230v, e280a

A/Wisconsin/13/2010i260m, r261q, p162s

A/Brisbane/11/2010 l194p

A/Hong Kong/3170/2010i260m, r261q, p162s

A/Fujian-Tong’an/196/2009

A/Shanghai-Luwan/1466/2010*d53n, y94h, t212a, i230v, e280a

A/Brisbane/220/2010 d53n, y94h, i230v, e280a

A/Kobe/357/2010 (MDCK cell)* d53n,y94y,230v

A/Okinawa/72/2010 (MDCK cell)* d53n,y94y,230v

A/Yokohama/96/2010 (MDCK cell) d53n,y94y,230v

10

hi antibody responses to the a h3n2 component gmt
HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT (% GMT)

This slide summarizes average geometric mean antibody titers of vaccine trials by HI test, indicating that A/Perth/16/2009-like HA antigen stimulated antibodies of similar titers to the vaccine and recent H3N2 viruses.

% GMT

11

antigenic cartography of b victoria viruses cambridge university
Antigenic cartography of B/Victoria viruses (Cambridge University)

This slide shows the antigenic map generated from HI data using ferret sera and B viruses. Viruses are represented as circles, antisera as squares. Vaccine strains are represented by the larger dots, other strains are coloured by antigenic cluster. Grid indicates 1 unit of antigenic distance, a 2-fold dilution in HI titer.

B/Singapore/616/2008

13

antigenic cartography of b yamagata viruses cambridge university
Antigenic cartography of B/Yamagata viruses (Cambridge University)

This slide shows the antigenic map generated from HI data using ferret sera and B viruses. Viruses are represented as circles, antisera as squares. Vaccine strains are represented by the larger dots, other strains are coloured by antigenic cluster. Grid indicates 1 unit of antigenic distance, a 2-fold dilution in HI titer.

14

antigens for serology b 2011
Antigens for serology:B 2011

VACCINE VIRUS

B/Brisbane/60/2008

REPRESENTATIVE CURRENT VIRUSES

B/Singapore/616/2008* clade 6

B/Bolivia/1526/2010* clade 6

B/Georgia/28/2010* clade 1

B/Genoa/2/2010

B/Hunan-Yuhua/1930/2010 clade 1

B/Heilongjiang-Hulan/116/2010clade 1

B/Victoria/506/2010 clade 1

B/Hiroshima/9/2010 (egg or cell) clade 1

  • B/Florida/4/2006
  • B/Wisconsin/1/2010
  • B/Hubei Wujiagang/158/2009
  • B/England/110/2010
  • B/Washington/1/2010
  • B/Guangdong-Luohu/1512/2010
  • B/Fujian Gulou/1272/2008

15

hi antibody responses to the b component gmt
HI ANTIBODY RESPONSES TO THE B COMPONENT (% GMT)

This slide summarizes average geometric mean antibody titers of vaccine trials by HI test, indicating that B/Brisbine/60/2008 HA antigen stimulated antibodies of similar titers to the vaccine and recent B/Vic/2/87 lineage viruses, but titers were lower to recent B/Yamagate/16/88 lineage viruses.

% GMT

16

conclusions
Conclusions
  • H1N1
    • Representative recent pandemic A(H1N1) viruses were covered by vaccine containing A/California/07/2009
  • H3N2
    • Representative recent (H3N2) viruses were covered by vaccine containing A/Perth/16/2009-like vaccines
  • B
    • B/VICTORIA/2/87-lineage
      • Representative recent viruses were well covered by current vaccine
    • B/YAMAGATA/16/88-lineage
      • Representative recent viruses were less well covered by current vaccine

17