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

 

 

 

 

CURRENT TO FEBRUARY 7, 2004


TABLE OF CONTENTS

 

 

 

 

SerUM panelS ..…………………………………………………………………….3

 

ANTIGENS ……….……………………………………………………………………..4

 

H1N1 ADULT AND ELDERLY………………………………………………………5-6

 

H3N2 ADULT AND ELDERLY ...……………………………………………………7-8

 

B ADULT AND ELDERLY …………………………………………………………9-10

 

2001 VACCINE STUDY FOR B SEROLOGIES …………………………………..11

 

PEDIATRIC SEROLOGIES ………………………………………………………….12

 

ACKNOWLEDGEMENTS…………………………………………………………….13

 

 


 

 

SERUM PANELS USED FOR STUDIES

 

 

          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)

                                   


                                   

ANTIGENS FOR SEROLOGIES

 

            H1N1

                                                A/New Caledonia/20/99 IVR116*                         E9

                        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

                                                A/Texas/141/03                                                      E4

                                                A/Kumamoto/102/02                                           X4E6

                                                A/Wyoming/03/03                                                 SpfCK2E3

                                                A/Hong Kong/1186/03                                              SpfCK3E4

 

            B

                                                            B/Shandong/07/97*  **                                                                              E8

                                                            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

 

 

 

 

 

 


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

 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

CARYN STRUPCZEWSKI

GALINA VODEIKO, PH.D.

ZHIPING YE, M.D., PH.D.

ROLAND A. LEVANDOWSKI, M.D.