Table 4.
Subtyping assay for RBD-IgG and titration for N-IgG in the phase 1 trial.
| Baseline | Day 28 | Day 42 | |||||||
| Items | 5 μg group (N = 24) | 10 μg group (N = 24) | Placebo group (N = 12) | 5 μg group (N = 23) | 10 μg group (N = 24) | Placebo group (N = 12) | 5 μg group (N = 23) | 10 μg group (N = 23) | Placebo group (N = 12) |
| IgG1 GMT | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 34.4 (25.2–47.0) | 42.4 (30.0–59.8) | 5.0 (5.0–5.0) | 30.5 (25.6–37.1) | 31.4 (22.5–43.9) | 5.0 (5.0–5.0) |
| IgG2 GMT | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 5.2 (4.8–5.5) | 5.5 (4.6–6.5) | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 5.3 (4.7–6.0) | 5.0 (5.0–5.0) |
| IgG3 GMT | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 5.8 (4.9–7.0) | 6.7 (5.2–8.5) | 5.0 (5.0–5.0) | 5.2 (4.8–5.5) | 5.8 (4.8–7.1) | 5.0 (5.0–5.0) |
| IgG4 GMT | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 5.0 (5.0–5.0) | 12.0 (9.0–16.0) | 17.3 (12.1–24.7) | 5.0 (5.0–5.0) | 9.4 (7.0–12.7) | 12.7 (9.2–17.5) | 5.0 (5.0–5.0) |
| N-IgG GMT | 11.9 (7.2–19.7) | 10.0 (6.7–14.9) | 6.3 (4.7–8.4) | 90.3 (50.4–161.7) | 358.8 (208.9–616.2) | 5.6 (4.7–6.7) | 122.0 (72.2–206.2) | 394.7 (240.6–647.8) | 6.3 (4.5–8.9) |
Data are GMT (95% CI). CI: Confidence interval; GMT: Geometric mean titer; N-IgG: Antibody directed against nucleoprotein; N: Number of participants included in each treatment group for the per-protocol immunogenicity analysis; RBD-IgG: Antibody directed against the receptor-binding domain.