Table 4. Microneutralization (MN) data by study group, intention-to-treat analysis.
| Group 1A | Group 1B | Group 1C | Group 2A | Group 2B | Group 2C | Group 3 | Group 4 | |||||||||||||||||
| 15μ H7N9 + adj IB160 | 7,5μ H7N9 + adj IB160 | 3,75μ H7N9 + adj IB160 | 15μ H7N9 + adj SE | 7,5μ H7N9 + adj SE | 3,75μ H7N9 + adj SE | 15μ H7N9, without adj | 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 | 51 | 8.6 | (7.6–9.7) | 47 | 7.4 | (6.4–8.5) | 54 | 9.0 | (7.8–10.4) | 49 | 8.1 | (7.0–9.4) | 54 | 7.5 | (6.6–8.6) | 51 | 8.5 | (7.2–10.0) | 52 | 8.3 | (7.2–9.6) | 49 | 7.5 | (6.6–8.6) |
| d28 | 50 | 15.0 | (12.0–18.7) | 47 | 13.2 | (10.3–17.0) | 53 | 12.9 | (10.0–16.7) | 49 | 11.0 | (8.9–13.5) | 53 | 9.7 | (8.2–11.4) | 51 | 8.6 | (7.1–10.3) | 52 | 8.7 | (7.5–10.0) | 49 | 6.1 | (5.6–6.7) |
| d56 | 50 | 67.3 | (50.4–89.8) | 44 | 78.6 | (52.0–118.8) | 53 | 67.8 | (44.6–103.2) | 48 | 61.7 | (41.8–91.1) | 54 | 28.5 | (20.3–39.9) | 51 | 28.1 | (20.3–38.9) | 52 | 17.0 | (13.2–21.9) | 48 | 5.9 | (5.4–6.6) |
| GMFR from Pre | ||||||||||||||||||||||||
| d28 | 50 | 1.7 | (1.4–2.2) | 47 | 1.8 | (1.4–2.2) | 53 | 1.4 | (1.1–1.8) | 49 | 1.4 | (1.1–1.7) | 53 | 1.3 | (1.1–1.5) | 51 | 1.0 | (0.8–1.2) | 52 | 1.0 | (0.9–1.2) | 49 | 0.8 | (0.7–0.9) |
| d56 | 50 | 7.8 | (5.9–10.4) | 44 | 10.4 | (6.8–15.9) | 53 | 7.5 | (4.9–11.4) | 48 | 7.8 | (5.3–11.5) | 54 | 3.8 | (2.7–5.3) | 51 | 3.3 | (2.2–4.9) | 52 | 2.1 | (1.6–2.6) | 48 | 0.8 | (0.7–0.9) |
| SPR, % | ||||||||||||||||||||||||
| Pre | 51 | 0.0 | (0.0–7.0) | 47 | 0.0 | (0.0–7.5) | 54 | 0.0 | (0.0–6.6) | 49 | 2.0* | (0.0–10.9) | 54 | 0.0 | (0.0–6.6) | 51 | 0.0 | (0.0–7.0) | 52 | 0.0 | (0.0–6.8) | 49 | 0.0 | (0.0–7.3) |
| d28 | 50 | 22.0 | (11.5–36.0) | 47 | 17.0 | (7.6–30.8) | 53 | 15.1 | (6.7–27.6) | 49 | 8.2 | (2.3–19.6) | 53 | 3.8 | (0.5–13.0) | 51 | 5.9 | (1.2–16.2) | 52 | 1.9 | (0.0–10.3) | 49 | 0.0 | (0.0–7.3) |
| d56 | 50 | 80.0 | (66.3–90.0) | 44 | 75.0 | (59.7–86.8) | 53 | 66.0 | (51.7–78.5) | 48 | 70.8 | (55.9–83.0) | 54 | 44.4 | (30.9–58.6) | 51 | 41.2 | (27.6–55.8) | 52 | 26.9 | (15.6–41.0) | 48 | 0.0 | (0.0–7.3) |
| SCR from Pre, % | ||||||||||||||||||||||||
| d28‡ | 50 | 18.0 | (8.6–31.4) | 47 | 12.8 | (4.8–25.7) | 53 | 13.2 | (5.5–25.3) | 49 | 8.2 | (2.3–19.6) | 53 | 1.9 | (0.0–10.1) | 51 | 2.0 | (0.0–10.4) | 52 | 0.0 | (0.0–6.8) | 49 | 0.0 | (0.0–7.3) |
| d56‡‡ | 50 | 78.0 | (64.0–88.5) | 44 | 75.0 | (59.7–86.8) | 53 | 60.4 | (46.0–73.5) | 48 | 68.8 | (53.7–81.30 | 54 | 38.9 | (25.9–53.1) | 51 | 33.3 | (20.8–47.9) | 52 | 25.0 | (14.0–38.9) | 48 | 0.0 | (0.0–7.3) |
adj: adjuvant; 95%CI: 95% confidence interval; GMT: geometric mean titters; 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.
*This percentage represents one single individual which presented the following titers: pre = 40, d28 = 20, d56 = 320.