Table 1.
Baseline characteristics of healthy Chinese adults aged 18 to 59 years participated in the phase 1 and phase 2 trials.
| Phase 1 trial (0/14) | Phase 2 trial (0/14) | Phase 2 trial (0/28) | |||||||
| Items | 5 μg group (N = 24) | 10 μg group (N = 24) | Placebo group (N = 12) | 5 μg group (N = 100) | 10 μg group (N = 100) | Placebo group (N = 50) | 5 μg group (N = 100) | 10 μg group (N = 100) | Placebo group (N = 50) |
| Age (years), mean (SD) | 38.0 (9.5) | 41.0 (10.3) | 38.3 (8.8) | 45.5 (9.3) | 44.9 (9.5) | 46.2 (9.2) | 42.4 (10.5) | 44.5 (10.7) | 41.7 (10.0) |
| Sex, n (%) | |||||||||
| Male | 12 (50) | 10 (42) | 8 (8/12) | 53 (53) | 45 (45) | 19 (38) | 38 (38) | 46 (46) | 25 (50) |
| Female | 12 (50) | 14 (58) | 4 (4/12) | 47 (47) | 55 (55) | 31 (62) | 62 (62) | 54 (54) | 25 (50) |
| Completed, n (%) | 23 (96) | 24 (100) | 12 (12/12) | 100 (100) | 97 (97) | 48 (96) | 98 (98) | 99 (99) | 49 (98) |
| Discontinued, n (%) | 1 (4) | 0 | 0 | 0 | 3 (3) | 2 (4) | 2 (2) | 1 (1) | 1 (2) |
| Neutralising antibody to live SARS-CoV-2 | |||||||||
| Seropositive | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| GMT | 2 (2–2) | 2 (2–2) | 2 (2–2) | 2 (2–2) | 2 (2–2) | 2 (2–2) | 2 (2–2) | 2 (2–2) | 2 (2–2) |
| Neutralising antibody to pseudovirus | |||||||||
| Seropositive | 0 | 0 | 0 | 6 (6, 2–13) | 1 (1, 0–5) | 0 | 2 (2, 0–7) | 2 (2, 0–7) | 2 (4, 0–14) |
| GMT | 8 (6–10) | 10 (8–12) | 7 (5–9) | 8 (7–9) | 8 (7–9) | 7 (6–8) | 11 (9–12) | 9 (8–10) | 9 (8–10) |
| RBD-IgG | |||||||||
| Seropositive | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2, 0–11) |
| GMT | 10 (10–10) | 10 (10–10) | 10 (10–10) | 11 (10–13) | 11 (10–12) | 10 (10–10) | 10 (10–12) | 10 (10–11) | 10 (10–11) |
Data are presented as n (95% CI [%]) for GMT, number of participants (%, 95% CI [%]) for seropositive (antibody titer ≥ detection limit). 0/14 or 0/28: Participants received two doses on Days 0 and 14 or Days 0 and 28, respectively; CI: Confidence interval. GMT: Geometric mean titer; N: Number of participants randomized into each treatment group; RBD-IgG: Antibody directed against the receptor-binding domain; SARS-CoV-2: Severe acute respiratory syndrome coronavirus 2; SD: Standard deviation.