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Table 2 Haemagglutination inhibition (HI) antibody immune responses to homologous and heterologous H5N1 influenza strains following one or two doses of the AS03A-adjuvanted A/Indonesia/5/2005 (H5N1) influenza vaccine were assessed in terms of seropositivity rates, GMTs, SCRs, SCFs and SPRs.

From: A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults

   

Seropositivity rates

GMT

SCR

(Negative pre-vaccination HI titre and P/V HI titre ≥1:40, or proportion with ≥4-fold increase from pre- to post vaccination)

SCF

(Mean GMT increase in titre >2.5 [adults]; >2.0 [aged over 60 y])

SPR

(% subjects with P/V HI titre ≥1:40)

Antibody

Group

D

N

n

% (95% CI)

Value (95% CI)

N

n

% (95% CI)

N

Value (95% CI)

N

n

% (95% CI)

A/Indonesia

20-40 Y

0

50

0

0.0 (0.0-7.1)

5.0 (5.0-5.0)

-

-

-

-

-

50

0

0.0 (0.0-7.1)

  

21

50

24

48.0 (33.7-62.6)

15.8 (11.0-22.8)

50

19

38.0 (24.7-52.8)

50

3.2 (2.2-4.6)

50

19

38.0 (24.7-52.8)

  

42

50

45

90.0 (78.2-96.7)

156.8 (105.8-232.3)

50

45

90.0 (78.2-96.7)

50

31.4 (21.2-46.5)

50

45

90.0 (78.2-96.7)

  

182

49

30

61.2 (46.2-74.8)

25.6 (17.3-38.1)

49

29

59.2 (44.2-73.0)

49

5.1 (3.5-7.6)

49

29

59.2 (44.2-73.0)

 

41-64 Y

0

50

5

10.0 (3.3-21.8)

5.4 (5.0-5.8)

-

-

-

-

-

50

0

0.0 (0.0-7.1)

  

21

50

27

54.0 (39.3-68.2)

15.4 (10.7-22.0)

50

16

32.0 (19.5-46.7)

50

2.8 (2.0-4.0)

50

16

32.0 (19.5-46.7)

  

42

50

48

96.0 (86.3-99.5)

142.1 (104.0-194.3)

50

46

92.0 (80.8-97.8)

50

26.2 (19.2-35.8)

50

46

92.0 (80.8-97.8)

  

182

50

40

80.0 (66.3-90.0)

37.4 (27.5-50.8)

50

38

76.0 (61.8-86.9)

50

6.9 (5.1-9.2)

50

38

76.0 (61.8-86.9)

A/turkey/Turkey

20-40 Y

0

50

2

4.0 (0.5-13.7)

5.7 (4.8-6.8)

-

-

-

-

-

50

2

4.0 (0.5-13.7)

  

21

50

13

26.0 (14.6-40.3)

8.0 (6.1-10.4)

50

3

6.0 (1.3-16.5)

50

1.4 (1.1-1.8)

50

5

10.0 (3.3-21.8)

  

42

50

30

60.0 (45.2-73.6)

24.8 (16.6-37.1)

50

27

54.0 (39.3-68.2)

50

4.4 (3.0-6.5)

50

29

58.0 (43.2-71.8)

  

182

49

30

61.2 (46.2-74.8)

19.2 (13.4-27.3)

49

18

36.7 (23.4-51.7)

49

3.4 (2.4-4.7)

49

20

40.8 (27.0-55.8)

 

41-64 Y

0

50

2

4.0 (0.5-13.7)

5.2 (4.9-5.5)

-

-

-

-

-

50

0

0.0 (0.0-7.1)

  

21

50

18

36.0 (22.9-50.8)

9.6 (7.3-12.5)

50

7

14.0 (5.8-26.7)

50

1.8 (1.4-2.4)

50

8

16.0 (7.2-29.1)

  

42

50

31

62.0 (47.2-75.3)

24.0 (16.1-35.6)

50

27

54.0 (39.3-68.2)

50

4.6 (3.1-6.8)

50

27

54.0 (39.3-68.2)

  

182

50

38

76.0 (61.8-86.9)

30.7 (22.2-42.5)

50

30

60.0 (45.2-73.6)

50

5.9 (4.2-8.2)

50

30

60.0 (45.2-73.6)

A/Vietnam

20-40 Y

0

50

1

2.0 (0.1-10.6)

5.2 (4.8-5.7)

-

-

-

-

-

50

1

2.0 (0.1-10.6)

  

21

50

5

10.0 (3.3-21.8)

5.7 (5.0-6.5)

50

0

0 (0-7.1)

50

1.1 (1.0-1.2)

50

1

2.0 (0.1-10.6)

  

42

50

26

52.0 (37.4-66.3)

12.7 (9.5-17.1)

50

14

28.0 (16.2-42.5)

50

2.4 (1.8-3.2)

50

15

30.0 (17.9-44.6)

  

182

49

17

34.7 (21.7-49.6)

8.6 (6.8-10.8)

49

2

4.1 (0.5-14.0)

49

1.6 (1.3-2.1)

49

3

6.1 (1.3-16.9)

 

41-64 Y

0

50

5

10.0 (3.3-21.8)

5.9 (5.0-6.8)

-

-

-

-

-

50

2

4.0 (0.5-13.7)

  

21

50

13

26.0 (14.6-40.3)

7.0 (5.8-8.5)

50

1

2.0 (0.1-10.6)

50

1.2 (1.1-1.4)

50

4

8.0 (2.2-19.2)

  

42

50

24

48.0 (33.7-62.6)

13.3 (9.7-18.2)

50

12

24.0 (13.1-38.2)

50

2.3 (1.7-3.0)

50

15

30.0 (17.9-44.6)

  

182

50

23

46.0 (31.8-60.7)

10.7 (8.2-13.9)

50

10

20.0 (10.0-33.7)

50

1.8 (1.4-2.4)

50

12

24.0 (13.1-38.2)

  1. Subjects received one dose of vaccine on Day 0 and one dose on Day 21 (ATP cohort for immunogenicity and persistence).
  2. 20-40 Y = subjects aged 20-40 years; 41-64 Y = subjects aged 41-64 years; GMT = geometric mean antibody titre; N = number of subjects with available results; n/% = number/percentage of subjects; P/V = post-vaccination; 95% CI = 95% confidence interval; D = Day, 0 = pre-vaccination, 21 = 21 days post vaccination one, 42 = 42 days post vaccination one (i.e. 21 days post vaccination two), 182 = 182 post vaccination one.
  3. Committee for Medicinal Products for Human Use (CHMP) criteria for adults 18-60 years: SCR >40%, SPR >70% and a SCF of >2.5
  4. US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) criteria for adults <65 years of age: Lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and the lower bound of the two-sided 95% CI for the percentage of subjects achieving a seroprotective level of HI antibody titre ≥1:40 should meet or exceed 70%.