Table 7.
Immunogenicity of phase 2 study: Humoral immune response after the single vaccination.
| Assay | Single vaccination |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 18–49 years |
≥ 50 years |
|||||||||
| Day 1 | Day 21 | Day 27 | Day 42 | Day 180 | Day 1 | Day 21 | Day 27 | Day 42 | Day 180 | |
| MNA | ||||||||||
| GMT (95% CI) | 1.0 (n/a) | 30 (21, 42) | 25 (19, 23) | 20 (16, 26) | 4 (3, 6) | 1.0 (n/a) | 24 (16, 36) | 30 (23, 40 | 27 (21, 35) | 5 (3, 7) |
| % sero conversion (95% CI) | n/a | 100 (93, 100) | 98 (90, 100) | 98 (90, 100) | 72 (56, 84) | n/a | 92 (81, 97) | 100 (93, 100) | 100 (93, 100) | 52 (38, 67) |
| ELISA | ||||||||||
| GMT (95% CI) | 50 (n/a) | 822 (471, 1436) | 1997 (1066, 3741) | 3478 (1855, 6519) | 1345 (544, 3325) | 50 (n/a) | 1041 (572, 1894) | 2263 (1183, 4329) | 3336 (1660, 6706) | 472 (207, 1077) |
| % seroconversion (95% CI) | n/a | 80 (67, 89) | 88 (76, 94) | 90 (79, 96) | 67 (50, 80) | n/a | 76 (63, 86) | 80 (67, 89) | 84 (71, 92) | 45 (31, 60) |
Data are GMTs and 95% CIs,% of sero conversion is the percentage of subjects with ≥ fourfold antibody titre increase compared to Day 1, n/a – not applicable.