Table 3. Haemagglutination inhibition (HI) data by study group, per protocol analysis.
| Group 1A | Group 1B | Group 1C | Group 2A | Group 2B | Group 2C | Group 3 | Group 4 | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 15μ H7N9 + IB160 | 7,5μ H7N9 + IB160 | 3,75μ H7N9 + IB160 | 15μ H7N9 + SE | 7,5μ H7N9 + SE | 3,75μ H7N9 + SE | 15μ H7N9, without adjuvant | Placebo | |||||||||||||||||
| n | Value | (95%CI) | n | Value | (95%CI) | n | Value | (95%CI) | N | Value | (95%CI) | n | Value | (95%CI) | n | Value | (95%CI) | n | Value | (95%CI) | n | Value | (95%CI) | |
| GMT | ||||||||||||||||||||||||
| Pre | 36 | 5.0 | (NE) | 31 | 5.0 | (NE) | 39 | 5.0 | (NE) | 35 | 5.0 | (NE) | 36 | 5.0 | (NE) | 35 | 5.0 | (NE) | 41 | 5.0 | (NE) | 37 | 5.0 | (NE) |
| d28 | 36 | 6.3 | (5.4–7.4) | 31 | 5.7 | (5.1–6.5) | 39 | 6.0 | (5.2–6.9) | 35 | 5.9 | (5.1–6.7) | 36 | 5.4 | (4.9–5.9) | 35 | 5.2 | (4.9–5.5) | 41 | 5.3 | (4.8–6.0) | 37 | 5.1 | (4.9–5.3) |
| d35 | 36 | 11.7 | (9.3–14.6) | 31 | 16.0 | (11.2–22.8) | 39 | 10.9 | (8.2–14.6) | 35 | 10.0 | (7.6–13.2) | 36 | 6.3 | (5.4–7.4) | 35 | 7.0 | (5.7–8.6) | 41 | 6.2 | (5.1–7.5) | 37 | 5.1 | (4.9–5.3) |
| d56 | 36 | 15.6 | (11.8–20.6) | 31 | 23.4 | (15.8–34.6) | 39 | 15.0 | (10.9–20.8) | 35 | 12.4 | (8.8–17.5) | 36 | 7.8 | (6.3–9.7) | 35 | 7.7 | (6.3–9.5) | 41 | 6.4 | (5.3–7.8) | 37 | 5.0 | (NE) |
| GMFR from Pre | ||||||||||||||||||||||||
| d28 | 36 | 1.3 | (1.1–1.5) | 31 | 1.1 | (1.0–1.3) | 39 | 1.2 | (1.0–1.4) | 35 | 1.2 | (1.0–1.3) | 36 | 1.1 | (1.0–1.2) | 35 | 1.0 | (1.0–1.1) | 41 | 1.1 | (1.0–1.2) | 37 | 1.0 | (1.0–1.0) |
| d35 | 36 | 2.3 | (1.9–2.9) | 31 | 3.2 | (2.2–4.6) | 39 | 2.2 | (1.6–2.9) | 35 | 2.0 | (1.5–2.6) | 36 | 1.3 | (1.1–1.5) | 35 | 1.4 | (1.1–1.7) | 41 | 1.2 | (1.0–1.5) | 37 | 1.0 | (1.0–1.1) |
| d56 | 36 | 3.1 | (2.4–4.1) | 31 | 4.7 | (3.2–6.9) | 39 | 3.0 | (2.2–4.2) | 35 | 2.5 | (1.8–3.5) | 36 | 1.6 | (1.3–1.9) | 35 | 1.5 | (1.3–1.9) | 41 | 1.3 | (1.1–1.6) | 37 | 1.0 | (1.0–1.0) |
| SPR, % | ||||||||||||||||||||||||
| Pre | 36 | 0.0 | (0.0–9.7) | 31 | 0.0 | (0.0–11.2) | 39 | 0.0 | (0.0–9.0) | 35 | 0.0 | (0.0–10.0) | 36 | 0.0 | (0.0–9.7) | 35 | 0.0 | (0.0–10.0) | 41 | 0.0 | (0.0–8.6) | 37 | 0.0 | (0.0–9.5) |
| d28 | 36 | 0.0 | (0.0–9.7) | 31 | 0.0 | (0.0–11.2) | 39 | 0.0 | (0.0–9.0) | 35 | 2.0 | (0.0–10.0) | 36 | 1.9 | (0.0–9.7) | 35 | 0.0 | (0.0–10.0) | 41 | 2.4 | (0.0–12.9) | 37 | 0.0 | (0.0–9.5) |
| d35 | 36 | 11.1 | (3.1–26.1) | 31 | 29.0 | (14.2–48.0) | 39 | 20.5 | (9.3–36.5) | 35 | 11.4 | (3.2–26.7) | 36 | 0.0 | (0.0–9.7) | 35 | 2.9 | (0.1–14.9) | 41 | 4.9 | (0.6–16.5) | 37 | 0.0 | (0.0–9.5) |
| d56 | 36 | 22.2 | (10.1–39.2) | 31 | 45.2 | (27.3–64.0) | 39 | 30.8 | (17.0–47.6) | 35 | 22.9 | (10.4–40.1) | 36 | 5.6 | (0.7–18.7) | 35 | 2.9 | (0.1–14.9) | 41 | 4.9 | (0.6–16.5) | 37 | 0.0 | (0.0–9.5) |
| SCR from Pre, % | ||||||||||||||||||||||||
| d28 | 36 | 0.0 | (0.0–9.7) | 31 | 0.0 | (0.0–11.2) | 39 | 0.0 | (0.0–9.0) | 35 | 2.0 | (0.0–10.0) | 36 | 1.9 | (0.0–9.7) | 35 | 0.0 | (0.0–10.0) | 41 | 2.4 | (0.0–12.9) | 37 | 0.0 | (0.0–9.5) |
| d35 | 36 | 11.1 | (3.1–26.1) | 31 | 29.0 | (14.2–48.0) | 39 | 20.5 | (9.3–36.5) | 35 | 11.4 | (3.2–26.7) | 36 | 0.0 | (0.0–9.7) | 35 | 2.9 | (0.1–14.9) | 41 | 4.9 | (0.6–16.5) | 37 | 0.0 | (0.0–9.5) |
| d56 | 36 | 22.2 | (10.1–39.2) | 31 | 45.2 | (27.3–64.0) | 39 | 30.8 | (17.0–47.6) | 35 | 22.9 | (10.4–40.1) | 36 | 5.6 | (0.7–18.7) | 35 | 2.9 | (0.1–14.9) | 41 | 4.9 | (0.6–16.5) | 37 | 0.0 | (0.0–9.5) |
adj: adjuvant; 95%CI: 95% confidence interval; GMT: geometric mean titers; GMFR: geometric mean fold rises, i.e., ratio between GMT of baseline and of post-dose; SPR: seroprotection rate (prior and postvaccination HI antibody titers ≥1:40); SCR: seroconversion rate (baseline HI antibody titers <1:10 and postvaccination HI antibody titers ≥1:40, or baseline HI antibody titers ≥1:10 and a postvaccination increase by a factor of four or more); Sample collected at: Pre (prior 1st dose), d28 (prior 2nd dose, 28 days post 1st dose), d35 (7 days post 2nd dose or 35 days post 1st dose), d56 (28 days post 2nd dose or 56 days post 1st dose); NE: not estimable.