Table 1.
Baseline characteristics of the SARS-CoV-2-naïve and exposed populations.
|
SARS-CoV-2-naïve population (Immunogenicity-PPS) |
SARS-CoV-2-exposed population (Immunogenicity-FAS Exposed) |
|||||
|---|---|---|---|---|---|---|
|
SCB-2019 N = 381 |
Placebo N = 47 |
Total N = 428 |
SCB-2019 N = 235 |
Placebo N = 28 |
Total N = 263 |
|
| Sex, n (%) | ||||||
| Male | 160 (42.0) | 19 (40.4) | 179 (41.8) | 114 (48.5) | 17 (60.7) | 131 (49.8) |
| Female | 221 (58.0) | 28 (59.6) | 249 (58.2) | 121 (51.5) | 11 (39.3) | 132 (50.2) |
| Age (years) | ||||||
| Mean (SD) | 36.0 (12.5) | 38.5 (13.8) | 36.3 (12.7) | 36.1 (13.2) | 34.9 (14.1) | 36.0 (13.3) |
| Median (range) | 35.0 (18–77) | 39.0 (18–68) | 35.0 (18–77) | 34.0 (18–72) | 31.5 (19–81) | 34.0 (18–81) |
| Age group, n (%) | ||||||
| ≥18 to ≤ 64 years | 374 (98.2) | 45 (95.7) | 419 (97.9) | 224 (95.3) | 27 (96.4) | 251 (95.4) |
| ≥65 years | 7 (1.8) | 2 (4.3) | 9 (2.1) | 11 (4.7) | 1 (3.6) | 12 (4.6) |
| ≥65 to ≤ 74 years | 6 (1.6) | 2 (4.3) | 8 (1.9) | 11 (4.7) | 0 | 11 (4.2) |
| ≥75 years | 1 (0.3) | 0 | 1 (0.2) | 0 | 1 (3.6) | 1 (0.4) |
| ≥18 to ≤ 59 years | 357 (93.7) | 43 (91.5) | 400 (93.5) | 220 (93.6) | 27 (96.4) | 247 (93.9) |
| ≥60 years | 24 (6.3) | 4 (8.5) | 28 (6.5) | 15 (6.4) | 1 (3.6) | 16 (6.1) |
| Race, n (%) | ||||||
| American Indian or Alaska Native | 30 (7.9) | 2 (4.3) | 32 (7.5) | 24 (10.2) | 0 | 24 (9.1) |
| Asian | 199 (52.2) | 20 (42.6) | 219 (51.2) | 174 (74.0) | 22 (78.6) | 196 (74.5) |
| Black or African American | 4 (1.0) | 0 | 4 (0.9) | 0 | 0 | 0 |
| White | 124 (32.5) | 23 (48.9) | 147 (34.3) | 20 (8.5) | 6 (21.4) | 26 (9.9) |
| Other | 24 (6.3) | 2 (4.3) | 26 (6.1) | 17 (7.2) | 0 | 17 (6.5) |
| Ethnicity, n (%) | ||||||
| Hispanic or Latino | 64 (16.8) | 9 (19.1) | 73 (17.1) | 59 (25.1) | 1 (3.6) | 60 (22.8) |
| Not Hispanic or Latino | 317 (83.2) | 38 (80.9) | 355 (82.9) | 176 (74.9) | 27 (96.4) | 201 (77.2) |
| Country, n (%) | ||||||
| Belgium | 131 (34.4) | 23 (48.9) | 154 (36.0) | 20 (8.5) | 6 (21.4) | 26 (22.8) |
| Colombia | 52 (13.6) | 4 (8.5) | 56 (13.1) | 41 (17.5) | 0 | 41 (15.6) |
| Philippines | 198 (52.0) | 20 (42.6) | 218 (50.9) | 174 (70.0) | 22 (78.6) | 196 (74.5) |
| High risk of severe COVID-19, n (%) | ||||||
| No | 307 (80.6) | 36 (76.6) | 343 (80.1) | 187 (79.6) | 24 (85.7) | 211 (80.2) |
| Yes | 74 (19.4) | 11 (23.4) | 85 (19.9) | 48 (20.4) | 4 (14.3) | 52 (19.8) |
| Obesity (BMI ≥ 30 kg/m2) | 46 (12.1) | 2 (4.3) | 48 (11.2) | 26 (11.1) | 1 (3.6) | 27 (10.3) |
| Hypertension | 24 (6.3) | 6 (12.8) | 30 (7.0) | 24 (10.2) | 2 (7.1) | 26 (9.9) |
| Type 2 diabetes mellitus | 7 (1.8) | 1 (2.1) | 8 (1.9) | 4 (1.7) | 0 | 4 (1.5) |
| Asthma | 7 (1.8) | 2 (4.3) | 9 (2.1) | 2 (0.9) | 0 | 2 (0.8) |
| Baseline SARS-Cov-2 serostatus, n (%) | ||||||
| Negative | 381 (100.0) | 47 (100.0) | 428 (100.0) | 1 (0.4)1 | 0 | 1 (0.4) |
| Positive | 0 | 0 | 0 | 234 (99.6) | 28 (1 0 0) | 262 (99.6) |
| Known history of COVID-19 at baseline, n (%) | ||||||
| No | 381 (100.0) | 47 (100.0) | 428 (100.0) | 217 (92.3) | 27 (96.4) | 244 (92.8) |
| Yes | 0 | 0 | 0 | 18 (7.7) | 1 (3.6) | 19 (7.2) |
| Baseline evidence of prior SARS-CoV-2 infection, n (%) | ||||||
| No | 381 (100.0) | 47 (100.0) | 428 (100.0) | 0 | 0 | 0 |
| Yes | 0 | 0 | 0 | 235 (1 0 0) | 28 (1 0 0) | 163 (1 0 0) |
Abbreviations: BMI, body mass index; PPS, per protocol set; FAS, full analysis set; SD, standard deviation.
N is the number of participants in each arm; n is the number of participants with available data.
1
This participant had a history of confirmed COVID-19.