Table 2.
Hemagglutination inhibition-based immunogenicity in the per-protocol immunogenicity cohort
|
Vaccine |
Sample time-point |
SCR/booster SCR
†
|
SPR |
||
|---|---|---|---|---|---|
|
n/N; % (95% CI) |
n/N; % (95% CI) |
||||
| Primary strain | Booster strain | Primary strain | Booster strain | ||
|
AS03
A
-H5N1 |
Day 0 |
– |
– |
15/933; 1.6 |
1/933; 0.1 |
| |
|
|
(0.9, 2.6) |
(0.0, 0.6) |
|
| Day 21 |
393/925; 42.5 |
24/925; 2.6 |
412/925; 44.5 |
27/925; 2.9 |
|
| |
(39.3, 45.7) |
(1.7, 3.8) |
(41.3, 47.8) |
(1.9, 4.2) |
|
| Day 42 |
866/924; 93.7 |
464/924; 50.2 |
871/924; 94.3 |
464/924; 50.2 |
|
| |
|
(92.0, 95.2) |
(46.9, 53.5) |
(92.6, 95.7) |
(46.9, 53.5) |
|
Heterologous booster |
Month 6 |
– |
– |
103/251; 41.0 |
9/251; 3.6 |
| |
|
|
(34.9, 47.4) |
(1.7, 6.7) |
|
| Month 6 + 21 |
233/256; 91.0† |
241/256; 94.1† |
242/251; 96.4 |
238/251; 94.8 |
|
| |
|
(86.8, 94.2) |
(90.5, 96.7) |
(93.3, 98.3) |
(91.3, 97.2) |
|
Non-adjuvanted-H5N1 |
Day 0 |
– |
– |
5/236; 2.1 |
0/236; 0.0 |
| |
|
|
(0.7, 4.9) |
(0.0, 1.6) |
|
| Day 21 |
8/234; 3.4 |
0/234; 0.0 |
16/234; 6.8 |
0/234; 0.0 |
|
| |
(1.5, 6.6) |
(0.0, 1.6) |
(4.0, 10.9) |
(0.0, 1.6) |
|
| Day 42 |
13/234; 5.6 |
1/234; 0.4 |
24/234; 10.3 |
1/234; 0.4 |
|
| |
|
(3.0, 9.3) |
(0.0, 2.4) |
(6.7, 14.9) |
(0.0, 2.4) |
|
Heterologous booster |
Month 6 |
– |
– |
4/224; 1.8 |
0/224; 0.0 |
| |
|
|
(0.5, 4.5) |
(0.0, 1.6) |
|
| Month 6 + 21 |
112/228; 49.1† |
106/228; 46.5† |
120/223; 53.8 |
105/223; 47.1 |
|
| |
(42.5, 55.8) |
(39.9, 53.2) |
(47.0, 60.5) |
(40.4, 53.9) |
|
| Month 6 + 42 |
173/228; 75.9† |
189/228; 82.9† |
180/228; 78.9 |
189/228; 82.9 |
|
| (69.8, 81.3) | (77.4, 87.5) | (73.1, 84.1) | (77.4, 87.5) | ||
CI, Confidence Interval; n/N, number of subjects fulfilling criteria for defined outcome/total number of subjects in group; SCR, seroconversion rates defined as percentage of subjects achieving an increase in HI titers from <1:10 to ≥1:40 or at least a 4-fold post-vaccination increase in HI titer from a pre-vaccination titer ≥1:10; †Booster SCR was SCR based on increases in HI antibody titers from pre-vaccination titers at Month 6; SPR, seroprotection rate defined as the percentage of subjects with HI titers ≥1:40 following vaccination; primary vaccine strain, H5N1/A/Vietnam/1194/2004; booster strain H5N1/A/Indonesia/5/2005.