Table 7.
MN titers and seroconversion.
| 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] | GMT (95% CI) | Seroconversion n (%) [95% CI] | |||||
| Titer cut-off ≥20 | Titer cut-off ≥10 | Titer cut-off ≥20 | Titer cut-off ≥10 | ||||||
| Placebo | – | 22 | 5.78 (4.60, 6.96) |
7.37 (4.62, 10.13) |
1 (4.5) [0.0, 0.2] |
1 (4.5) [0.0, 0.2] |
5.53 (4.77, 6.30) |
0 | 0 |
| 15 µg | + | 18 | 5.39 (4.88, 5.91) |
5.21 (4.83, 5.59) |
0 | 0 | 8.52 (5.04, 11.99) |
1 (5.6) [0.0, 0.2] |
3 (16.7) [0.0, 0.3] |
| 45 µg | + | 20 | 5.00 (5.00, 5.00) |
5.25 (4.82, 5.68) |
0 | 1 (5.0) [0.0, 0.1] |
11.26 (7.41, 15.11) |
3 (15.0) [0.0, 0.3] |
8 (40.0) [0.2, 0.6] |
| 90 µg | + | 20 | 5.10 (4.92, 5.28) |
5.21 (4.96, 5.45) |
0 | 0 | 11.06 (4.54, 17.58) |
2 (10.0) [0.0, 0.2] |
4 (20.0) [0.0, 0.4] |
| 90 µg | – | 20 | 8.33 (3.75, 12.91) |
132.75 (0, 284.45) |
2 (10.0) [0.0, 0.2] |
3 (15.0) [0.0, 0.3] |
133.77 (0.0, 285.35) |
3 (15.0) [0.0, 0.3] |
3 (15.0) [0.0, 0.3] |
a: A, Alhydrogel®.
b: GMT, geometric mean titer.
c: CI, confidence interval.