Table 2.
Neutralizing Antibody Against A/H7N9
| Group 1 3.75mcg+MF59 (D1-D29-D169) | Group 2 3.75mcg+MF59 (D1-D57-D169) | Group 3 7.5mcg+MF59 (D1-D29D169) | Group 4 7.5mcg+MF59 (D1-D57D169) | Group 5 15mcg+MF59 (D1-D29D169) | Group 6 15mcg+MF59 (D1-D57D169) | |
|---|---|---|---|---|---|---|
| Day 1 (Pre Vac 1, All Subjects) | ||||||
| n | 74 | 72 | 81 | 70 | 71 | 74 |
| GMT (95% CI) | 6.3 (5.7 – 6.8) | 6.7 (6.0 – 7.4) | 7.0 (6.4 – 7.7) | 6.0 (5.6 – 6.5) | 6.6 (6.0 – 7.2) | 6.8 (6.0 – 7.7) |
| Titer≥1:40 - %(95% CI) | 0.0 (0.0–4.9) | 0.0 (0.0–5.0) | 0.0 (0.0–4.5) | 0.0 (0.0–5.1) | 0.0 (0.0–5.1) | 1.4 (0.0–7.3) |
| Day 57 (28 Days Post Vac 2, Groups 1,3,5) a | ||||||
| n | 73 | - | 80 | - | 70 | - |
| GMT (95% CI) | 26.6 (20.1 – 35.2) | - | 20.7 (16.6 – 25.8) | - | 21.9 (17.1 – 28.0) | - |
| Titer≥1:40 - %(95% CI) | 46.6 (34.8–58.6) | - | 25.0 (16.0–35.9) | - | 25.7 (16.0–37.6) | - |
| Seroconversion - %(95% CI) | 42.5 (31.0–54.6) | - | 22.5 (13.9–33.2) | - | 25.7 (16.0–37.6) | - |
| Day 85 (56 Days Post Vac 2, Groups 1,3,5; 28 days Post Vac 2, Groups 2,4,6) | ||||||
| n | 73 | 72 | 81 | 70 | 71 | 74 |
| GMT (95% CI) | 21.3 (16.7 – 27.1) | 33.3 (25.1 – 44.2) | 18.5 (15.3 – 22.3) | 23.7 (18.0 – 31.1) | 19.3 (15.4 – 24.2) | 38.5 (29.2 – 50.8) |
| Titer≥1:40 - %(95% CI) | 37.0 (26.0–49.1) | 50.0 (38.0–62.0) | 23.5 (14.8–34.2) | 34.3 (23.3–46.6) | 25.4 (15.8–37.1) | 55.4 (43.4–67.0) |
| Seroconversion - %(95% CI) | 31.5 (21.1–43.4) | 47.2 (35.3–59.3) | 21.0 (12.7–31.5) | 34.3 (23.3–46.6) | 25.4 (15.8–37.1) | 47.3 (35.6–59.3) |
| Day 169 (Pre Vac 3, All Subjects) | ||||||
| n | 69 | 67 | 72 | 63 | 67 | 69 |
| GMT (95% CI) | 14.7 (12.2 – 17.8) | 18.9 (15.4 – 23.2) | 15.2 (12.6 – 18.4) | 14.1 (11.1 – 17.8) | 14.1 (11.6 – 17.3) | 22.0 (17.3 – 28.0) |
| Titer≥1:40 - %(95% CI) | 15.9 (8.2–26.7) | 19.4 (10.8–30.9) | 18.1 (10.0–28.9) | 14.3 (6.7–25.4) | 16.4 (8.5–27.5) | 36.2 (25.0–48.7) |
| Seroconversion - %(95% CI) | 13.0 (6.1–23.3) | 19.4 (10.8–30.9) | 15.3 (7.9–25.7) | 14.3 (6.7–25.4) | 16.4 (8.5–27.5) | 31.9 (21.2–44.2) |
| Day 197 (28 Days Post Vac 3, All Subjects) | ||||||
| n | 66 | 66 | 65 | 59 | 61 | 66 |
| GMT (95% CI) | 59.0 (41.8 – 83.3) | 49.3 (37.4 – 65.1) | 57.5 (42.1 – 78.6) | 45.5 (33.7 – 61.4) | 44.6 (32.6 – 60.9) | 70.5 (51.7 – 96.1) |
| Titer≥1:40 - %(95% CI) | 60.6 (47.8–72.4) | 65.2 (52.4–76.5) | 69.2 (56.6–80.1) | 61.0 (47.4–73.5) | 60.7 (47.3–72.9) | 78.8 (67.0–87.9) |
| Seroconversion - %(95% CI) | 59.1 (46.3–71.0) | 62.1 (49.3–73.8) | 64.6 (51.8–76.1) | 61.0 (47.4–73.5) | 59.0 (45.7–71.4) | 71.2 (58.7–81.7) |
n = number of subjects in the intention-to-treat population with available results; GMT = Geometric mean titer
a
Serum samples for antibody testing were not collected from subjects in Groups 2,4,6 at Day 57.