Table 5. Primary response following clade 2 A/Indonesia /5/05-RG2 as determined by HIH method.
| EMA threshold | Time after vaccination (days) | Primary vaccination 30 μg + adjuvant (n = 50) | |
|---|---|---|---|
| GMT (95% CI) | None | 0 | 4.0 (4.0; 4.0) |
| 21 | 4.4 (4.08; 4.760 | ||
| 42 | 12.8 (8.84; 18.6) | ||
| GMTR % (95% CI) | > 2.5 | 21 | 2.9 (2.08; 4.06) |
| 42 | 3.20 (2.21; 4.64) | ||
| Seroconversion% (95% CI) | > 40% | 21 | 0.0 (0.0; 7.1) |
| 42 | 26.0 (14.6; 40.3) | ||
| Seroprotection % (titre ≥ 32) | > 70% | 0 | 0.0 (0.0;7.1) |
| 21 | 0.0 (0.0; 7.1) | ||
| 42 | 26 (14.6; 40.3) |
n = number of participants
EMA: European Medicines Authority
GMT: Geometric mean titer
GMTR: Geometric mean titer ratio (post-vaccination titer/pre-vaccination titer)
*Seroconversion: subjects with pre-vaccination titers < 8 and post-vaccination titres > 32 or significant increase in titres defined as pre-vaccination titre < 8 with at least a 4-fold increase in post-vaccination titers