Table 3.
Prepandemic influenza vaccines: immunogenicity data of healthy adults aged 18–60 years recorded 21 days after second vaccination
| Vaccine formulation | N | Immunogenic virus strain | Dose HA | HI Ab response | Neutralizing Ab response | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SCF [95% CI] | SCR [95% CI] | SPR [95% CI] | GMT [95% CI] | SCR [95% CI] | |||||||||
| Non‐adj | Adj | Non‐adj | Adj | Non‐adj | Adj | Non‐adj | Adj | Non‐adj | Adj | ||||
| Inactivated split A/Vietnam/ 1194/2004 NIBRG‐14 vaccine containing H5 antigen with or without adjuvant | 400 | A/Vietnam | 3·75 μg (n = 50) | 1·2 [1·1–1·5] | 27·9 [17·2–45·2] | 4% [0·5–13·7] | 82% [68·6–91·4] | 4% [0·5–13·7] | 84% [70·9–92·8] | 40·7 [32·4–51·0] | 314·7 [243·1–407·3] | 22·0% [11·5–36·0] | 85·7% [72·8–94·1] |
| 7·5 μg (n = 50) | 1·7 [1·3–2·3] | 38·1 [24·8–58·4] | 16% [7·3–29·7] | 90% [78·2–96·7] | 16% [7·3–29·7] | 90% [78·2–96·7] | 53·4 [41·6–68·6] | 343·0 [260·5–451·5] | 36·7% [23·4–51·7] | 86·0% [73·3–94·2] | |||
| 15 μg (n = 50) | 2·8 [1·9–4·1] | 60·5 [42·8–85·5] | 35% [21·7–49·6] | 96% [86·0–99·5] | 35% [21·7–49·6] | 96% [86·0–99·5] | 80·1 [60·1–107·0] | 400·1 [319·3–501·4] | 53·1% [38·3–67·5] | 85·7% [72·8–94·1] | |||
| 30 μg (n = 50) | 3·9 [2·4–6·2] | 36·4 [22·7–58·5] | 41% [27·0–55·8] | 85% [72·2–93·9] | 43% [28·8–57·8] | 85·0% [72·2–93·9] | 113·6 [85·5–150·9] | 258·2 [205·5–324·5] | 64·6% [49·5–77·8] | 97·9% [88·7–99·9] | |||
| A/Indonesia | 3·75 μg (n = 50) | 1·0 [1·0–1·0] | 2·0 [1·4–2·8] | 0% [0·0–7·4] | 20·0% [10·0–33·7] | 0% [0·0–7·1] | 20·0% [10·0–33·7] | 14·5 [13·5–15·7] | 80·3 [62·0–103·9] | 2·3% [0·1–12·3] | 77·1% [62·7–88·0] | ||
| A/Turkey | 3·75 μg (n = 20) | 1·0 [1·0–1·0] | 3·4 [1·9–6·1] | 0% [0·0–16·8] | 35·0% [15·4–59·2] | 0% [0·0–16·8] | 35·0% [15·4–59·2] | 16·1 [13·6–19·1] | 97·3 [72·5–130·6] | 0% [0·0–16·8] | 75·0% [50·9–91·3] | ||
| A/Anhui | 3·75 μg (n = 20) | 1·1 [0·9–1·5] | 4·7 [2·6–8·5] | 5·0% [0·1–24·9] | 60·0% [36·1–80·9] | 5·0% [0·1–24·9] | 60·0% [36·1–80·9] | 16·7 [12·4–22·5] | 113·2 [80·7–158·9] | 0% [0·0–19·5] | 85·0% [62·1–96·8] | ||
| 1206 | A/Vietnam | 3·75 μg (n = 234)* (n = 933)** | 1·3 [1·2–1·5] | 39·8 [36·8–43·1] | 5·6% [3·0–9·3] | 93·7% [92·0–95·2] | 10·3% [6·7–14·9] | 94·3% [92·6–95·7] | 7·5 [6·7–8·5] | 219·4 [203·3–236·9] | 32·4% [21·8–44·5] | 96·0% [93·0–98·0] | |
| A/Indonesia | 3·75 μg (n = 234)* (n = 933)** | 1·0 [1·0–1·1] | 4·9 [4·5–5·4] | 0·4% [0·0–2·4] | 50·2% [46·9–53·5] | 0·4% [0·0–2·4] | 50·2% [46·9–53·5] | 5·2 [5·0–5·4] | 24·9 [22·8–27·3] | 5·6% [1·6–13·8] | 91·4% [87·5–94·4] | ||
N, number of volunteers; n, number of volunteers with available results in each vaccine group. HAI, hemagglutination inhibition; Ab, antibody; SCF, seroconversion factor (see definition in Table 1); SCR, seroconversion rate (see definition in Table 1); SPR, seroprotection rate (see definition in Table 1); GMT, geometric mean titer of serum antibodies; Non‐adj, non‐adjuvanted; Adj, adjuvanted.
*Number of volunteers with available results in non‐adjuvanted vaccine group.
**Number of volunteers with available results in adjuvanted vaccine group.