Table 1.
Demographic characteristics of the participants in the Abdala trial at enrollment.
| Variable | Short schedule (0-14-28 days) |
Long schedule (0-28-56 days) |
Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | RBD 25 μg | RBD 50 μg | Subtotal | Placebo | RBD 25 μg | RBD 50 μg | Subtotal | |||
| PHASE 1 (19-54 years) | ||||||||||
| N | 22 | 22 | 22 | 66 (50·0) | 22 | 22 | 22 | 66 (50.0) | 132 (100) | |
| Sex – no. (%) | Female | 11 (50·0) | 7 (31·8) | 9 (40·9) | 27 (40·9) | 10 (45·5) | 12 (54·5) | 11 (50·0) | 33 (50·0) | 60 (45·5) |
| Male | 11 (50·0) | 15 (68·2) | 13 (59·1) | 39 (59·1) | 12 (54·5) | 10 (45·5) | 11 (50·0) | 33 (50·0) | 72 (55·5) | |
| Age | years | 37·9 ± 10·0 | 40·7 ± 7·3 | 44·4 ± 9·2 | 41·0 ± 9·2 | 41·1 ± 9·4 | 39·9 ± 9·4 | 44·2 ± 8·3 | 41·7 ± 9·1 | 41·3 ± 9·1 |
| Ethnicity – no. (%) |
White | 4 (18·2) | 4 (18·2) | 7 (31·8) | 15 (22·7) | 7 (31·8) | 3 (13·6) | 2 (9·1) | 12 (18·2) | 27 (20·5) |
| Black | 11 (50·0) | 2 (9·1) | 6 (27·3) | 19 (28·8) | 6 (27·3) | 4 (18·2) | 8 (36·4) | 18 (27·3) | 37 (28·0) | |
| Mestizo | 7 (31·8) | 16 (72·7) | 9 (40·9) | 32 (48·5) | 9 (40·9) | 15 (68·2) | 12 (54·5) | 36 (54·5) | 68 (51·5) | |
| BMI | Kg/m2 | 25·2 ± 4·0 | 26·5 ± 4·7 | 25·5 ± 3·3 | 25·7 ± 4·0 | 24·4 ± 3·3 | 25·9 ± 3·3 | 26·3 ± 4·4 | 25·5 ± 3·7 | 25·6 ± 3·9 |
| PHASE 2 (19-80 years; short schedule: 0-14-28 days) | ||||||||||
| Age group: 19 - 54 years | Age group: 55 - 80 years | |||||||||
| N | 153 | 149 | 151 | 453 (62·4) | 89 | 93 | 91 | 273 (37·6) | 726 (100) | |
| Sex – no. (%) | Female | 76 (49·7) | 80 (53·7) | 76 (50·3) | 232 (51·2) | 28 (31·5) | 40 (43·0) | 37 (40·7) | 105 (38·5) | 337 (46·4) |
| Male | 77 (50·3) | 69 (46·3) | 75 (49·7) | 221 (48·8) | 61 (68·5) | 53 (57·0) | 54 (59·3) | 168 (61·5) | 389 (53·6) | |
| Age | years | 35·7 ± 12·0 | 35·6 ± 11·4 | 30·1 ± 12·5 | 35·0 ± 12·0 | 65·7 ± 8·0 | 63·2 ± 7·5 | 64·0 ± 7·3 | 64·3 ± 7·2 | 46·5 ± 17·3 |
| Ethnicity – no. (%) |
White | 53 (34·6) | 63 (42·3) | 51 (33·8) | 167 (36·9) | 28 (31·5) | 24 (25·8) | 35 (38·4) | 87 (31·9) | 254 (35·0) |
| Black | 34 (22·2) | 20 (13·4) | 17 (11·3) | 71 (15·7) | 25 (28·1) | 17 (18·3) | 16 (17·6) | 58 (21·2) | 129 (17·8) | |
| Mestizo | 66 (43·1) | 66 (44·3) | 83 (55·0) | 215 (47·5) | 36 (40·4) | 52 (55·9) | 40 (44·0) | 128 (46·9) | 343 (47·2) | |
| BMI | Kg/m2 | 25·1 ± 4·2 | 25·2 ± 4·1 | 24·7 ± 4·1 | 25·0 ± 4·1 | 25·9 ± 4·0 | 27·2 ± 4·4 | 26·6 ± 4·4 | 26·6 ± 4·3 | 25·6 ± 4·3 |
Plus-minus values are means ± SD.
BMI: Body-mass index (is the weight in kilograms divided by the square of the height in meters. The calculation was based on the weight and height measured at the time of screening). RBD: receptor binding domain.