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. 2021 Apr 28;134(11):1289–1298. doi: 10.1097/CM9.0000000000001573

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.