PRELIMINARY
INFORMATION ON SEROLOGIC RESPONSES
TO
INFLUENZA VIRUS VACCINES
PREPARED
FOR
VACCINES
AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
18-19
FEBRUARY 2004
DATA FROM
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
BETHESDA,
MARYLAND
TABLE OF CONTENTS
SERUM
SUPPLIED BY VACCINE
COMPONENTS
1. ALAN
HAMPSON ADULTS A/NEW CALEDONIA/20/99-LIKE (H1N1)
WHO,
MELBOURNE, AUSTRALIA ELDERLY A/PANAMA/2007/99 (H3N2)
B/SHANGDONG/07/97
2. JOHN
WOOD, PH.D ADULTS A/NEW CALEDONIA/20/99 (H1N1)
NIBSC,
LONDON, ENGLAND ELDERLY A/PANAMA/2007/99 (H3N2)
B/SHANGDONG/7/97
3. TAKATO ODIGARI, PH.D. ADULTS A/NEW CALEDONIA/20/99-LIKE (H1N1)
TOKYO,
JAPAN ELDERLY A/PANAMA/2007/99-LIKE (H3N2)
B/HONG KONG/330/01-LIKE
4. STEFAN GRAVENSTEIN, M.D. ADULTS A/NEW
CALEDONIA/20/99-LIKE (H1N1)
EASTERN
VIRGINIA ELDERLY A/PANAMA/2007/99-LIKE (H3N2)
MEDICAL
SCHOOL PEDIATRIC B/HONG
KONG/330/01-LIKE
5. STEFAN GRAVENSTEIN, M.D. ADULTS A/NEW
CALEDONIA/20/99-LIKE (H1N1)
EASTERN
VIRGINIA ELDERLY A/PANAMA/2007/99-LIKE (H3N2)
MEDICAL
SCHOOL B/VICTORIA/504/2000
(VACCINE
USED IN 2001-02)
H1N1
A/Belem/84066/03 (H1N2) E5
A/Virginia/20/03 X2C2E1
H3N2
A/Panama/2007/99
RESVIR17* E6
A/Texas/40/03
SpfCK4E4
A/Chile/8266e/2003 SpfCK4E4
A/Fiujian/445/03 E6
A/Victoria/584/03 E4
B
B/Hong Kong/1434/02* ** E5
B/Sichuan/259/03** C2E3
B/Jilin/20/03** E5
* = REPRESENTATIVE OF VACCINE STRAINS
**
= ETHER TREATED
E =
EGG PASSED VIRUS
X = UNKNOWN
C = TISSUE CULTURE
SpfCK = SPECIFIC PATHOGEN FREE CHICK embryo KIDNEY
HEMAGGLUTINATION INHIBITION
ANTIBODY TITERS TO INFLUENZA A (H1N1) VIRUSES
|
TRIAL |
TEST SITE |
NO. OF SERA |
VIRUS
STRAIN |
GMT
PRE POST |
%>32or40
PRE POST |
% 4 FOLD RISE |
||
|
AUSTRALIA ADULTS (2/2004) |
CBER
|
24 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
<8 <8 <8 |
68 117 52 |
17 21 5 |
88 92 83 |
83 88 88 |
|
EUROPE ADULTS(2/2004) |
|
24 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
<8 <8 <8 |
25 27 18 |
4 4 0 |
58 54 50 |
58 67 58 |
|
JAPAN ADULTS (2/2004) |
|
25 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
<8 <8 <8 |
16 16 12 |
16 16 0 |
32 44 20 |
48 36 28 |
|
USA ADULTS (2/2004) |
|
20 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
11 9 9 |
39 45 44 |
20 20 20 |
75 75 70 |
40 50 50 |
|
|
|
|
* Vaccine Strain
|
|
|
|
|
|
HEMAGGLUTINATION INHIBITION
ANTIBODY TITERS TO INFLUENZA A (H1N1) VIRUSES
|
TRIAL |
TEST SITE |
NO. OF SERA |
VIRUS
STRAIN |
GMT
PRE POST |
%>32or40
PRE POST |
% 4 FOLD RISE |
||
|
AUSTRALIA ELDERLY (2/2004) |
CBER
|
24 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
10 20 13 |
24 35 39 |
13 54 38 |
58 75 83 |
38 33 42 |
|
EUROPE ELDERLY (2/2004) |
|
24 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
<8 <8 <8 |
9 13 10 |
4 0 4 |
17 33 17 |
25 38 29 |
|
JAPAN ELDERLY (2/2004) |
|
30 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
<8 <8 <8 |
<8 9 <8 |
7 13 10 |
27 30 27 |
23 23 30 |
|
USA ELDERLY (2/2004) |
|
17 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
<8 <8 <8 |
18 20 28 |
12 12 24 |
41 35 47 |
29 47 35 |
|
|
|
|
* Vaccine
Strain |
|
|
|
|
|
HEMAGGLUTINATION INHIBITION
ANTIBODY TITERS TO INFLUENZA A (H3N2) VIRUSES
|
TRIAL |
TEST SITE |
# SERA |
VIRUS
STRAIN |
GMT
PRE POST |
%>32or40
PRE POST |
4 FOLD |
||
|
AUSTRALIA ADULTS (2/2004) |
CBER |
24 |
A/Panama/2007/99 A/Texas/40/03 A/Chile/8266/03
A/Fiujian/445/03 A/Victoria/584/03 A/Texas/141/03
|
<16
<16 21 18 17 <16 |
64
39 88 72 78 24 |
25
21 54 33 38 33 |
92
88 88 88 96 38 |
63
54 46 46 63 25 |
|
EUROPE ADULTS (2/2004) |
|
24 |
A/Panama/2007/99 A/Texas/40/03 A/Chile/8266/03
A/Fiujian/445/03 A/Victoria/584/03 A/Texas/141/03 |
<16 <16 <16 <16 <16 <16 |
18
<16 28 27 28 <16 |
4
0 8 0 4 8 |
42
42 58 54 46 29 |
50
50 58 54 33 21 |
|
JAPAN ADULTS (2/2004) |
|
25 |
A/Panama/2007/99 A/Texas/40/03 A/Chile/8266/03
A/Fiujian/445/03 A/Victoria/584/03 A/Texas/141/03 |
<16 <16 <16 <16 <16 <16 |
17
<16 23 <16 17 18 |
16
8 28 16 12 20 |
40
16 56 36 40 40 |
20
4 20 12 28 16 |
|
USA ADULTS (2/2004) |
|
21 |
A/Panama/2007/99 A/Texas/40/03 A/Chile/8266/03
A/Fiujian/445/03 A/Victoria/584/03 A/Texas/141/03 |
27
<16 29 20 24 17 |
64
43 129 75 92 27 |
67
38 57 43 48 38 |
81
81 95 81 85 53 |
38
29 52 57 52 19 |
|
|
|
|
*Vaccine
Strain |
|
|
|
|
|
HEMAGGLUTINATION INHIBITION
ANTIBODY TITERS TO INFLUENZA A (H3N2) VIRUSES
|
TRIAL |
TEST SITE |
# SERA |
VIRUS
STRAIN |
GMT
PRE POST |
%>32or40
PRE POST |
4 FOLD |
||
|
AUSTRALIA ELDERLY (2/2004) |
CBER |
24 |
A/Panama/2007/99 RESVIR17* A/Texas/40/03 A/Chile/8266/03
A/Fiujian/445/03 A/Victoria/584/03 A/Texas/141/03 |
18
<16 21 20 20 <16 |
38
28 59 48 44 30 |
42
33 46 38 38 33 |
67
58 71 63 58 67 |
17
25 33 25 25 29 |
|
JAPAN ELDERLY
(2/2004) |
|
30 |
A/Panama/2007/99 RESVIR17* A/Texas/40/03 A/Chile/8266/03
A/Fiujian/445/03 A/Victoria/584/03 A/Texas/141/03 |
<16 <16 <16 <16 <16 <16 |
<16 <16 18 <16 <16 <16 |
43
37 60 37 43 17 |
63
40 83 37 50 20 |
23
20 23 3 3 3 |
|
USA ELDERLY
(2/2004) |
|
21 |
A/Panama/2007/99 RESVIR17* A/Texas/40/03 A/Chile/8266/03
A/Fiujian/445/03 A/Victoria/584/03 A/Texas/141/03 |
28
20 37 24 31 17 |
48
29 83 56 65 24 |
67
48 67 38 48 29 |
95
71 100 81 86 52 |
19
14 33 43 38 5 |
|
|
|
|
*Vaccine
Strain |
|
|
|
|
|
HEMAGGLUTINATION
INHIBITION ANTIBODY TITERS TO INFLUENZA B VIRUSES
|
TRIAL |
TEST SITE |
NO. OF SERA |
VIRUS
STRAIN |
GMT
PRE POST |
%>32or40
PRE POST |
% 4 FOLD RISE |
||
|
AUSTRALIA ADULTS (2/2004) |
CBER |
24 |
B/Shandong/07/97*
B/Hong Kong/1434/02 B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 19 |
64
87 49 64 |
17
8 8 46 |
92
92 79 75 |
79
88 75 50 |
|
EUROPE ADULTS (2/2004) |
|
24 |
B/Shandong/07/97*
B/Hong Kong/1434/02 B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 <8 |
17
18 19 <8 |
0
0 0 8 |
46
46 46 38 |
46
54 54 38 |
|
Japan ADULTS (2/2004) |
|
25 |
B/Shandong/07/97*
B/Hong Kong/1434/02* B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 18 |
<8
18 19 28 |
32
36 33 48 |
52
52 56 60 |
12
32 24 16 |
|
USA ADULTS (2/2004) |
|
21 |
B/Shandong/07/97
B/Hong Kong/1434/02* B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 18 |
42
71 57 71 |
5
5 5 43 |
71
86 81 85 |
71
86 76 43 |
|
|
|
|
*Vaccine
Strain |
|
|
|
|
|
|
TRIAL |
TEST SITE |
NO. OF SERA |
VIRUS
STRAIN |
GMT
PRE POST |
%>32or40
PRE POST |
% 4 FOLD RISE |
||
|
AUSTRALIA ELDERLY
(2/2004) |
CBER |
24 |
B/Shandong/07/97*
B/Hong Kong/1434/02 B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 <8 |
30
43 21 51 |
8
8 8 29 |
67
97 58 79 |
67
79 58 46 |
|
EUROPE ELDERLY (2/2004) |
|
24 |
B/Shandong/07/97*
B/Hong Kong/1434/02 B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 <8 |
11
12 14 11 |
4
4 4 21 |
26
33 38 33 |
38
42 46 21 |
|
JAPAN ELDERLY (2/2004) |
|
30 |
B/Shandong/07/97*
B/Hong Kong/1434/02* B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 <8 |
9
10 9 <8 |
30
43 43 23 |
37
50 37 23 |
10
3 7 3 |
|
USA ELDERLY
(2/2004) |
|
21 |
B/Shandong/07/97
B/Hong Kong/1434/02* B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 23 |
56
51 45 58 |
5
10 10 33 |
62
48 48 62 |
62
76 57 29 |
|
|
|
|
*Vaccine
Strain |
|
|
|
|
|
HEMAGGLUTINATION INHIBITION ANTIBODY TITERS: 2001-2002 VACCINES
|
TRIAL |
TEST SITE |
NO. OF SERA |
VIRUS
STRAIN |
GMT
PRE POST |
%>32or40
PRE POST |
% 4 FOLD RISE |
||
|
USA ADULTS (2/2004) |
CBER |
16 |
B/Victoria/504/00* B/Sichuan/259/03 B/Jilin/20/03 |
64
<8 30 |
157
16 76 |
75
31 50 |
93
50 88 |
13
31 31 |
|
USA ELDERLY
(2/2004) |
|
15 |
B/Victoria/504/00* B/Sichuan/259/03 B/Jilin/20/03 |
18
<8 21 |
31
12 24 |
47
13 47 |
60
27 53 |
20
20 0 |
|
|
|
|
*Vaccine
Strain |
|
|
|
|
|
PEDIATRIC HEMAGGLUTINATION INHIBITION ANTIBODY TITERS TO INFLUENZA
VIRUSES
|
TRIAL |
TEST SITE |
NO. OF SERA |
VIRUS
STRAIN |
GMT
PRE POST |
%>32or40
PRE POST |
% 4 FOLD RISE |
||
|
PEDIATRIC |
CBER |
30 |
A/New Caledonia/20/99*
A/Belem/84066/03
(H1N2) A/Virginia/20/03 |
<8
<8 <8 |
25
39 34 |
10
10 10 |
50
63 77 |
80
83 93 |
|
PEDIATRIC (2/2004) |
|
31 |
A/Panama/2007/99* A/Kumamoto/102/02 A/Wyoming/03/03
A/Hong
Kong/1186/03 |
<8
<8 <8 <8 |
40
31 13 11 |
10
13 10 10 |
58
61 16 13 |
87
74 39 32 |
|
PEDIATRIC |
|
30 |
B/Shandong/07/97*
B/Hong Kong/1434/02* B/Sichuan/259/03 B/Jilin/20/03 |
<8
<8 <8 <8 |
21
31 26 <8 |
3
0 0 0 |
57
75 67 3 |
77
83 80 7 |
|
|
|
Range
8-38 (Months) Mean 21 |
*Vaccine
Strain |
|
|
|
|
|
CONTRIBUTING PERSONNEL
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
BETHESDA,
MARYLAND
TERESA
LIU, M.S.
JONATHAN
MCINNIS
GALINA
VODEIKO, PH.D.
ZHIPING
YE, M.D., PH.D.
ROLAND A. LEVANDOWSKI, M.D.