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Table 4 Neutralizing antibody-based immunogenicity with 95% CI in the per-protocol immunogenicity cohort

From: Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults

 

Month

6

6 + 21 days

12

12 + 21

24

36

36 + 21

48

Titre ≥1:28 n/N; % (95% CI)

Booster at Month 6

Primary strain

162/163; 99.4

163/163; 100

75/75; 100

–

74/75; 98.7

71/75; 94.7

–

73/75; 97.3

(96.6, 100)

(97.8, 100)

(95.2, 100)

 

(92.8, 100)

(86.9, 98.5)

 

(90.7, 99.7)

Booster strain

160/162; 98.8

162/162; 100

74/74; 100

–

70/74; 94.6

66/75; 88.0

–

67/75; 89.3

(95.6, 99.9)

(97.7, 100)

(95.1, 100)

 

(86.7, 98.5)

(78.4, 94.4)

 

(80.1, 95.3)

Booster Month 12

Primary strain

–

–

162/164; 98.8

170/170; 100

75/75; 100

73/74; 98.6

–

74/75; 98.7

  

(95.7, 99.9)

(97.9, 100)

(95.2, 100)

(92.7, 100)

 

(92.8, 100)

Booster strain

–

–

135/164; 82.3

170/170; 100

72/75; 96.0

69/74; 93.2

–

73/75; 97.3

  

(75.6, 87.8)

(97.9, 100)

(88.8, 99.2)

(84.9, 97.8)

 

(90.7, 99.7)

Booster Month 36

Primary strain

–

–

–

–

58/75; 77.3

55/75; 73.3

74/74; 100

74/75; 98.7

    

(66.2, 86.2)

(61.9, 82.9)

(95.1, 100)

(92.8, 100)

Booster strain

–

–

–

–

17/75; 22.7

19/75; 25.3

75/75; 100

74/75; 98.7

    

(13.8, 33.8)

(16.0, 36.7)

(95.2, 100)

(92.8, 100)

 

Month

6

6 + 21 days

12

12 + 21

24

36

36 + 21

48

GMT value (95% CI)

Booster at Month 6

Primary strain

169.9;

1566.3;

159.4;

–

74.0;

62.0;

–

71.4;

(152.3, 189.4)

(1342.1, 1827.9)

(128.1, 198.2)

 

(62.5, 87.5)

(52.1, 73.7)

 

(61.8, 82.5)

Booster strain

179.7;

2702.0;

134.0;

–

66.3;

55.4;

–

54.5;

(161.8, 199.7)

(2270.4, 3215.6)

(107.4, 167.3)

 

(54.5, 80.8)

(45.5, 67.6)

 

(45.8, 64.7)

Booster Month 12

Primary strain

–

–

204.1;

2734.9;

164.9;

121.1;

–

117.4;

  

(179.9, 231.6)

(2334.4, 3204.2)

(125.7, 216.2)

(91.7, 159.9)

 

(92.7, 148.6)

Booster strain

–

–

58.5;

2363.2;

148.9;

106.9;

–

103.4;

  

(50.8, 67.3)

(2037.5, 2740.9)

(111.8, 198.3)

(81.6, 140.0)

 

(79.5, 134.4)

Booster Month 36

Primary strain

–

–

–

–

33.3;

31.8;

1373.4;

429.0;

    

(28.8, 38.4)

(27.3, 36.9)

(1023.7, 1842.6)

(322.2, 571.2)

Booster strain

–

–

–

–

16.7;

17.3;

1154.3;

320.4;

    

(15.4, 18.1)

(15.8, 19.0)

(847.8 1571.4)

(243.7, 421.4)

 

Month

6

6 + 21 days

12

12 + 21

24

36

36 + 21

48

Booster SCR n/N;% (95% CI)

Booster at Month 6

Primary strain

–

121/163; 74.2

7/75; 9.3

–

1/75; 1.3

0/75; 0.0

–

0/75; 0.0

 

(66.8, 80.8)

(3.8, 18.3)

 

(0.0, 7.2)

(0.0, 4.8)

 

(0.0, 4.8)

Booster strain

–

144/162; 88.9

4/74; 5.4

–

0/74; 0.0

0/75; 0.0

–

1/75; 1.3

 

(83.0, 93.3)

(1.5, 13.3)

 

(0.0, 4.9)

(0.0, 4.8)

 

(0.0, 7.2)

Booster Month 12

Primary strain

–

–

–

141/164; 86.0

7/75; 9.3

5/74; 6.8

–

2/75; 2.7

   

(79.7, 90.9)

(3.8, 18.3)

(2.2, 15.1)

 

(0.3, 9.3)

Booster strain

–

–

–

159/164; 97.0

34/75; 45.3

27/74; 36.5

–

27/75; 36.0

   

(93.0, 99.0)

(33.8, 57.3)

(25.6, 48.5)

 

(25.2, 47.9)

Booster Month 36

Primary strain

–

–

–

–

–

–

73/74; 98.6

64/75; 85.3

      

(92.7, 100)

(75.3, 92.4)

Booster strain

–

–

–

–

–

–

75/75; 100

72/75; 96.0

       

(95.2, 100)

(88.8, 99.2)

  1. CI, confidence interval; n/N, number of subjects fulfilling definition of outcome/total number of subjects in group; GMT, geometric mean titer; Booster SCR, Booster seroconversion rate defined as percentage of subjects with pre-booster titer <1:28 and post-booster titer of ≥1:56, or pre-booster titer ≥1:28 and ≥4-fold post-booster; Primary vaccine strain, H5N1/A/Vietnam/1194/2004; heterologous booster strain H5N1/A/Indonesia/5/2005.
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