Influenza Vaccine Responses

Roland A. Levandowski, M.D.

Division of Viral Products

Prepared for Vaccines and Related Biological Products Advisory Committee18-19 February 2004

 

 

1. ALAN HAMPSON ADULT A/NEW CALEDONIA/20/99-LIKE (H1N1)

WHO, AUSTRALIA ELDER A/PANAMA/2007/99 (H3N2)

B/SHANGDONG/07/97

 

2. JOHN WOOD, PH.D ADULT A/NEW CALEDONIA/20/99 (H1N1)

NIBSC, ENGLAND ELDER A/PANAMA/2007/99 (H3N2)

B/SHANGDONG/7/97

 

3. TAKATO ODIGARI, PH.D. ADULT A/NEW CALEDONIA/20/99-LIKE (H1N1)

WHO, JAPAN ELDER A/PANAMA/2007/99-LIKE (H3N2)

B/HONG KONG/330/01-LIKE

 

Serum Panels for Serologies

Serum Panels for Serologies

   

4. STEFAN GRAVENSTEIN, M.D. ADULT A/NEW CALEDONIA/20/99 (H1N1)

EASTERN VIRGINIA ELDER A/PANAMA/2007/99 (H3N2)

MEDICAL SCHOOL CHILD B/HONG KONG/1434/2002

 

5. CHRISTINE TURLEY, M.D. CHILD A/NEW CALEDONIA/20/99 (H1N1)

UTMB A/PANAMA/2007/99 (H3N2)

GALVESTON, TEXAS B/HONG KONG/1434/2002

 6. STEFAN GRAVENSTEIN, M.D. ADULT B/VICTORIA/504/2000 ELDER (VACCINE USED IN 2001-02)

7. JOHN WOOD, PH.D ADULT B/JOHANNESBURG/5/99

(VACCINE USED IN 2001-02)

ANTIGENS FOR SEROLOGIES (H1)

VACCINE STRAIN

A/NEW CALEDONIA/20/99 (H1N1)

REPRESENTATIVE CURRENT STRAINS

A/DAKAR/85/2003 (H1N1)

A/MINNESOTA/18/2003 (H1N1)

A/NAGANO/1328/2003 (H1N1)

A/BELEM/84066/03 (H1N2)

A/ICELAND/123/2003 (H1N2)

A/PERU/2223/2003 (H1N2)

A/VIRGINIA/20/03 (H1N2)

HI ANTIBODY RESPONSES TO THE H1 COMPONENT2003-2004 INFLUENZA VACCINE

ADULT POPULATION (CDC)

STUDY N ANTIGEN % RISE PRE POST PRE POST

USA 24 A/NEW CALEDONIA/20/99+ 35 11 36 13 58A/MINNESOTA/18/2003+ 26 25 76 52 79A/VIRGINIA/20/2003* 43 10 29 13 50A/BELEM/84066/2003 * 39 7 23 0 42

EU 24 A/NEW CALEDONIA/20/99+ 58 5 27 0 54A/MINNESOTA/18/2003+ 67 7 44 8 63A/VIRGINIA/20/2003* 63 5 22 0 42A/BELEM/84066/2003 * 50 5 17 0 29

JAPAN 25 A/NEW CALEDONIA/20/99+ 44 8 19 8 32A/MINNESOTA/18/2003+ 48 10 30 20 52A/VIRGINIA/20/2003* 48 6 16 4 32A/BELEM/84066/2003 * 36 6 13 0 20

+ = H1N1 * = H1N2

GMT % HI > 40

HI ANTIBODY RESPONSES TO THE H1 COMPONENT2003-2004 INFLUENZA VACCINEELDERLY POPULATION (NIBSC)

STUDY N ANTIGEN % RISE PRE POST PRE POST

EU 24 A/NEW CALEDONIA/20/99+ 67 7 58 8 75A/DAKAR/85/2003+ 63 9 59 13 79A/VIRGINA/20/2003* 46 8 55 8 63A/ICELAND/123/2003* 50 9 48 13 71A/NAGANO/1328/2003+ 67 10 87 13 83

USA 24 A/NEW CALEDONIA/20/99+ 25 36 69 50 83A/DAKAR/85/2003+ 8 53 90 62 96A/VIRGINA/20/2003* 13 29 47 54 71A/ICELAND/123/2003* 17 38 69 58 83A/NAGANO/1328/2003+ 25 47 85 67 96

JAPAN 24 A/NEW CALEDONIA/20/99+ 17 42 87 75 88A/DAKAR/85/2003+ 17 56 99 79 88A/VIRGINA/20/2003* 21 30 58 54 71A/ICELAND/123/2003* 17 42 81 67 83A/NAGANO/1328/2003+ 17 47 87 75 88

+ = H1N1 * = H1N2

GMT % HI > 40

HI ANTIBODY RESPONSES TO THE H1 COMPONENT2003-2004 INFLUENZA VACCINE

PEDIATRIC POPULATION (CDC AND CBER)

STUDY N ANTIGEN % RISE PRE POST PRE POST

CDC 25 A/NEW CALEDONIA/20/99 56 5 18 0 32A/MINNESOTA/18/2003 22 6 10 4 16

AGE < 24 MONTHS A/VIRGINIA/20/2003 63 5 35 0 48A/BELEM/84066/2003 41 5 13 0 20

CBER 30 A/NEW CALEDONIA/20/99 80 <8 25 10 50A/BELEM/84066/2003 83 <8 39 10 63

MEAN AGE= 21 MONTHS A/VIRGINIA/20/2003 93 <8 34 10 77

GMT % HI > 40

SEROLOGIES POST 2 DOSES VACCINE

A/NEW CALEDONIA/20/99-LIKE VACCINESSUMMARY TABLE

VIRUSES WITH > 50% GMT REDUCTION

VIRUSES CBER CDC NIBSC AUS NIID TOTAL % REDUCED

A/BELEM/84066/2003 * 0/9 0/7 0/8 1/8 1/31 29 (0-53)

A/VIRGINIA/20/2003 * 0/9 0/7 1/8 1/24 30 (0-59)

A/ICELAND/123/2003 * 1/8 1/8 29 (0-54)

A/DAKAR/85/2003 + 0/8 0/8 0

A/NAGAN0/1328/2003+ 0/8 0/8 0/16 4 (0-30)

A/MINNESOTA/18/2003+ 0/7 0/8 0/4 0/19 21 (0-46)

* = H1N2 + = H1N1

ANTIGENS FOR SEROLOGIES (H3)

VACCINE STRAINA/PANAMA/2007/99

REPRESENTATIVE CURRENT STRAINSA/CHILE/82660/2003A/AICHI/205/2003*A/KUMAMOTO/102/2002*A/FUJIAN/445/2003*A/NAGASAKI/152/2003* * = FUJIAN/411-LIKEA/TEXAS/40/2003*A/TEXAS/141/2003*A/WYOMING/03/2003*A/HONG KONG/1186/2002*

HI ANTIBODY RESPONSES TO THE H3 COMPONENT2003-2004 INFLUENZA VACCINE

ADULT POPULATION ( AUS )

STUDY N ANTIGEN % RISE PRE POST PRE POST

EU 24 A/PANAMA/2007/99 67 9 40 8 58A/VICTORIA/584/2003 54 6 25 4 33A/TEXAS/40/2003 42 7 21 4 33A/CHILE/82660/2003 50 7 28 0 38A/WYOMING/03/2003 42 7 20 0 25

USA 22 A/PANAMA/2007/99 32 60 132 82 91A/VICTORIA/584/2003 36 23 53 45 73A/TEXAS/40/2003 18 23 43 41 68A/CHILE/82660/2003 23 18 36 27 59A/WYOMING/03/2003 27 17 35 18 59

AUS 24 A/PANAMA/2007/99 71 19 123 29 92A/VICTORIA/584/2003 71 11 67 17 88A/TEXAS/40/2003 63 12 46 8 75A/CHILE/82660/2003 54 11 44 8 63A/WYOMING/03/2003 50 10 37 0 50

GMT % HI > 40

HI ANTIBODY RESPONSES TO THE H3 COMPONENT2003-2004 INFLUENZA VACCINEELDERLY POPULATION (CDC)

STUDY N ANTIGEN % RISE PRE POST PRE POST

USA 23 A/PANAMA/2007/99 24 43 93 76 100A/TEXAS/40/2003 14 27 40 62 74A/FUJIAN/445/2003 24 18 32 38 57A/CHILE/82660/2003 24 8 12 5 9A/NAGASAKI/52/2003 19 18 27 38 52

JAPAN 30 A/PANAMA/2007/99 20 30 53 57 73A/TEXAS/40/2003 13 27 42 47 73A/FUJIAN/445/2003 10 30 41 60 73A/CHILE/82660/2003 3 9 10 13 17A/NAGASAKI/52/2003 10 18 24 30 40

AUS 24 A/PANAMA/2007/99 25 34 92 54 75A/TEXAS/40/2003 33 20 60 38 63A/FUJIAN/445/2003 29 16 49 29 63A/CHILE/82660/2003 25 8 18 8 29A/NAGASAKI/52/2003 46 16 50 29 67

GMT % HI > 40

HI ANTIBODY RESPONSES TO THE H3 COMPONENT2003-2004 INFLUENZA VACCINE

PEDIATRIC POPULATION (CDC AND CBER)

STUDY N ANTIGEN % RISE PRE POST PRE POST

CDC 25 A/PANAMA/2007/99 63 5 50 0 64A/TEXAS/40/2003 44 5 33 0 48

AGE < 24 MONTHS A/FUJIAN/445/2003 44 5 31 0 48A/CHILE/82660/2003 41 5 13 0 24A/NAGASAKI/52/2003 44 5 29 0 48

CBER 30 A/PANAMA/2007/99 87 <8 40 10 58A/KUMAMOTO/102/2002 74 <8 31 13 61

MEAN AGE= 21 MONTHS A/WYOMING/03/2003 39 <8 13 10 16A/HONG KONG/1186/2003 32 <8 11 10 13

GMT % HI > 40

SEROLOGIES POST 2 DOSES VACCINE

A/PANAMA/2007/99-LIKE VACCINESSUMMARY TABLE

VIRUSES WITH > 50% GMT REDUCTION

VIRUSES CBER CDC NIBSC AUS NIID TOTAL % REDUCED

A/CHILE/82660/2003 0/7 9/9 0/8 7/8 8/8 24/40 55 (0-93)

A/WYOMING/03/2003* 1/1 8/8 2/3 11/12 64 (49-76)

A/TEXAS/40/2003* 0/7 2/9 0/8 5/8 7/32 39 (0-71)

A/AICHI/205/2003* 6/8 6/8 57 (5-81)

A/VICTORIA/584/2003* 0/7 8/8 5/8 13/23 44 (0-83)

A/NAGASAKI/52/2003* 6/9 8/8 14/17 73 (41-95)

A/FUJIAN/445/2003* 0/7 2/9 2/16 24 (0-66)

* = A/FUJIAN-LIKE

ANTIGENS FOR SEROLOGIES (B)

VACCINE STRAINCURRENT VACCINE OLDER VACCINEB/SHANGDONG/7/97+ B/JOHANNESBURG/5/99B/HONG KONG/1434/2002+ B/VICTORIA/504/2000

REPRESENTATIVE CURRENT STRAINSB/SICHUAN/259/2003+

B/BADEN-WURTENBURG/26/2002*B/SHAHGHAI/361/2002*B/JIANGSU/10/2003* + = HONG KONG/330-LIKEB/JILIN/20/2003* * = SHANGHAI/361-LIKEB/MALAYSIA/879/2003*B/WASHINGTON/3/2003*

HI ANTIBODY RESPONSES TO THE B COMPONENT2003-2004 INFLUENZA VACCINE

ADULT POPULATION (NIBSC)

STUDY N ANTIGEN % RISE PRE POST PRE POST

EU 24 B/SHANGDONG/7/97 50 6 34 4 54B/SICHUAN/259/2003 + 54 6 33 0 54B/JILIN/20/2003* 13 5 10 0 13B/BADEN-W'BURG/2003* 46 7 24 8 54

AUS 24 B/SHANGDONG/7/97 71 6 62 0 71B/SICHUAN/259/2003 + 71 6 73 0 79B/JILIN/20/2003* 29 6 15 4 33B/BADEN-W'BURG/2003* 54 10 53 17 71

JAPAN 24 B/SHANGDONG/7/97 17 12 23 21 42B/SICHUAN/259/2003 + 8 11 15 25 33B/JILIN/20/2003* 4 8 11 13 17B/BADEN-W'BURG/2003* 4 12 15 29 42

+ = VACCINE -LIKE * = SHANGHAI/361-LIKE

GMT % HI > 40

HI ANTIBODY RESPONSES TO THE B COMPONENT2003-2004 INFLUENZA VACCINEELDERLY POPULATION (CDC)

STUDY N ANTIGEN % RISE PRE POST PRE POST

USA 23 B/HONG KONG/1434/2002 67 11 57 19 78B/SICHUAN 259/2003 + 67 10 51 10 74B/JILIN/20/2002* 24 15 33 24 43B/WASHINGTON/03/2003* 24 17 38 38 52B/JIANGSU/10/2003* 14 15 28 19 43

EU 24 B/HONG KONG/1434/2002 54 6 23 4 42B/SICHUAN 259/2003 + 54 6 19 4 38B/JILIN/20/2002* 13 7 11 4 13B/WASHINGTON/03/2003* 21 7 12 4 13B/JIANGSU/10/2003* 25 6 11 0 13

JAPAN 30 B/HONG KONG/1434/2002 0 18 22 30 40B/SICHUAN 259/2003 + 13 14 20 30 43B/JILIN/20/2002* 0 9 10 17 20B/WASHINGTON/03/2003* 0 9 10 13 20B/JIANGSU/10/2003* 7 8 10 10 13

+ = VACCINE -LIKE * = SHANGHAI/361-LIKE

GMT % HI > 40

HI ANTIBODY RESPONSES TO THE B COMPONENT2003-2004 INFLUENZA VACCINE

PEDIATRIC POPULATION (CDC AND CBER)

STUDY N ANTIGEN % RISE PRE POST PRE POST

CDC 25 B/HONG KONG/1434/2002 41 6 15 4 24B/SICHUAN 259/2003 + 30 5 14 0 28

AGE < 24 MONTHS B/JILIN/20/2002* 7 5 6 0 4B/WASHINGTON/03/2003* 7 5 6 4 8B/JIANGSU/10/2003* 0 5 5 0 0

CBER 30 B/HONG KONG/1434/2002 83 <8 31 0 75B/SICHUAN 259/2003+ 80 <8 26 0 67

MEAN AGE= 21 MONTHS B/JILIN/20/2002* 7 <8 <8 0 3

GMT % HI > 40

SEROLOGIES POST 2 DOSES VACCINE"+ = VACCINE-LIKE * = SHANGHAI/361-LIKE"

HI ANTIBODY RESPONSES TO THE B COMPONENT2001-2002 INFLUENZA VACCINE

ADULT AND ELDERLY (NIBSC AND CBER)

STUDY N ANTIGEN % RISE PRE POST PRE POST

EU ADULT 24 B/JOHANNESBURG/5/99 88 7 110 8 86B/JILIN/20/2003 83 6 80 0 80B/BADEN-W/BURG/26/2003 83 7 93 4 93

USA ADULT 16 B/VICTORIA/504/2000 54 64 157 75 93B/JILIN/20/2003 31 30 76 50 88

ELDERLY 15 B/VICTORIA/504/2000 20 18 31 75 88B/JILIN/20/2003 0 21 24 79 88

GMT % HI > 40

B/HONG KONG/330/2001-LIKE VACCINESSUMMARY TABLE

VIRUSES WITH > 50% GMT REDUCTION

VIRUSES CBER CDC NIBSC AUS NIID TOTAL % REDUCED

B/BADEN-W'BURG/26/2003 * 3/8 3/8 37 (0-65)

B/JILIN/20/2003 * 2/9 3/8 8/8 3/8 16/33 43 (0-76)

B/SHANGHAI/361/2002 * 5/8 5/8 49 (11-71)

B/WASHINGTON/3/2003 * 3/8 3/8 41 (4-60)

B/JIANGSU/10/2003 * 8/8 8/8 58 (51-77)

B/SICHUAN/259/2003 + 1/9 0/8 2/8 0/8 3/33 18 (0-62)

* = SHANGHAI/361-LIKE + = VACCINE-LIKE

Influenza Vaccine ResponsesSummary

Studies with sera collected after immunization with current vaccines show that:

Representative influenza A (H1N1) and (H1N2) viruses are well-inhibited

Many a/Fujian/411/2002 (H3N2)-like viruses are less well inhibited than the the vaccine strain

B/Hong Kong/330/2001-like viruses are well inhibited but B/Shanghai/361/2002 and similar viruses are less well inhibited than the vaccine strains