Table 6.
Dose of HAI-05 | A a | N subjects per group | Pre-vaccination (Day 1) | Post-1st vaccination (Day 22) | Post-2nd vaccination (Day 43) | ||||
---|---|---|---|---|---|---|---|---|---|
GMT b (95% CI c) | GMT (95% CI) | Seroconversion n (%) (95% CI) | Titer ≥40 n (%) (95% CI) | GMT (95% CI) | Seroconversion n (%) (95% CI) | Titer ≥40 n (%) (95% CI) | |||
Placebo | – | 22 | 5.0 (5.0, 5.0) |
5.0 (5.0, 5.0) |
0 | 0 | 5.0 (5.0, 5.0) |
0 | 0 |
15 µg | + | 18 | 5.0 (5.0, 5.0) |
5.0 (5.0, 5.0) |
0 | 0 | 6.41 (4.16, 8.66) |
0 | 0 |
45 µg | + | 20 | 5.0 (5.0, 5.0) |
5.0 (5.0, 5.0) |
0 | 0 | 6.16 (4.15, 8.18) |
0 | 0 |
90 µg | + | 20 | 5.0 (5.0, 5.0) |
5.0 (5.0, 5.0) |
0 | 0 | 6.85 (3.83, 9.88) |
1
(5.0) (0, 0.1) |
1
(5.0) (0, 0.1) |
90 µg | – | 20 | 6.75 (3.72, 9.78) |
36.50 (0, 73.99) |
2
(10.0) (0, 0.2) |
2
(10.0) (0, 0.2) |
43.23 (0, 89.35) |
2
(10.0) (0, 0.2) |
2
(10.0) (0, 0.2) |
a: A, Alhydrogel®.
b: GMT, geometric mean titer.
c: CI, confidence interval.