Table 1 Baseline characteristics of study participants enrolled in the different phases (ITT, as Randomized)
Phase 1 | Phase 2 | Phase 3a | Phase 3b | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
ARCT-154 (N = 75) | Placebo (N = 25) | ARCT-154 (N = 226) | Placebo (N = 75) | ARCT-154 (N = 448) | Placebo (N = 152) | ARCT-154 (N = 8059) a | Placebo (N = 8048) a | |||
Female gender | n (%) | 35 (46.7) | 14 (56.0) | 109 (48.2) | 36 (48.0) | 194 (43.3) | 67 (44.1) | 4099 (50.9) | 4088 (50.8) | |
Age (years) | Median (Q1, Q3) | 31 (25, 40) | 33 (27, 43) | 38 (28, 49) | 42 (29, 53) | 45 (36, 54) | 43 (34, 55) | 48 (37, 57) | 48 (37, 57) | |
Ethnicity | Kinh | n (%) | 74 (98.7) | 24 (96.0) | 217 (96.0) | 75 (100) | 443 (98.9) | 148 (97.4) | 8025 (99.6) | 8001 (99.4) |
Others | 1 (1.3) | 1 (4.0) | 9 (4.0) | 0 (0) | 5 (1.1) | 4 (2.6) | 34 (0.4) | 47 (0.6) | ||
Weight (kg) | Median (Q1, Q3) | 59 (50, 68) | 55 (49, 62) | 58 (51, 66) | 58 (50, 64) | 60 (53, 67) | 58 (50, 67) | 56 (51, 63) | 56 (50, 63) | |
BMI (kg/cm2) | Median (Q1, Q3) | 23 (19, 25) | 22 (19, 24) | 23 (21, 26) | 23 (21, 25) | 24 (22, 26) | 23 (21, 26) | 23 (21, 25) | 23 (21, 25) | |
Risk of severe COVID-19 b | ||||||||||
18-59- year-olds with co-morbidities | n (%) | 0 (0) | 0 (0) | 70 (31.0) | 25 (33.3) | 177 (39.5) | 59 (38.8) | 2816 (34.9) | 2810 (34.9) | |
≥ 60 years | 0 (0) | 0 (0) | 22 (9.7) | 8 (10.7) | 58 (12.9) | 21 (13.8) | 1401 (17.4) | 1401 (17.4) | ||
Vaccination compliance | Received dose 1 | n (%) | 75 (100) | 25 (100) | 226 (100) | 75 (100) | 448 (100) | 152 (100) | 8056 (100) | 8044 (100) |
Received dose 2 | 74 (98.7) | 25 (100) | 225 (99.6) | 75 (100) | 434 (96.9) | 145 (95.4) | 7869 (97.6) | 7831 (97.3) | ||
Anti-N protein antibody negative | n (%) | In phases 1, 2 and 3a all (100%) ARCT-154 participants & all (100%) Placebo participants were negative | 8005 (99.3) | 7999 (99.4) | ||||||
Anti-N protein antibody positive | n (%) | 54 (0.7) | 49 (0.6) | |||||||
