Table 2.
Adverse events and reactions in the phase 1 trial
| Placebo (n=10) | 25 μg dose (n=20) | 50 μg dose (n=20) | p value | |
|---|---|---|---|---|
| Overall adverse events within 30 days | ||||
| Any | 6 (60%) | 14 (70%) | 18 (90%) | 0·1786 |
| Grade ≥3 | 0 | 0 | 2 (10%) | 0·3469 |
| Solicited adverse events within 7 days | ||||
| Any | 3 (30%) | 12 (60%) | 14 (70%) | 0·1286 |
| Grade ≥3 | 0 | 0 | 1 (5%) | 1·0000 |
| Solicited systemic adverse reactions | ||||
| Any | 1 (10%) | 4 (20%) | 5 (25%) | 0·7423 |
| Fever | 0 | 2 (10%) | 0 | 0·3469 |
| Headache | 0 | 1 (5%) | 1 (5%) | 1·0000 |
| Fatigue | 0 | 0 | 1 (5%) | 1·0000 |
| Weakness | 0 | 0 | 1 (5%) | 1·0000 |
| Cough | 0 | 1 (5%) | 3 (15%) | 0·5123 |
| Impaired appetite | 1 (10%) | 0 | 0 | 0·2000 |
| Nausea | 0 | 0 | 2 (10%) | 0·3469 |
| Muscle pain | 0 | 1 (5%) | 0 | 1·0000 |
| Solicited local adverse reactions | ||||
| Any | 2 (20%) | 9 (45%) | 12 (60%) | 0·1298 |
| Grade ≥3 | 0 | 0 | 1 (5%) | 1·0000 |
| Injection-site pain | 2 (20%) | 4 (20%) | 11 (55%) | 0·0527 |
| Swelling | 0 | 1 (5%) | 3 (15%) | 0·5132 |
| Grade ≥3 swelling | 0 | 0 | 1 (5%) | 1·0000 |
| Induration | 0 | 2 (10%) | 5 (25%) | 0·187 |
| Redness | 1 (10%) | 4 (20%) | 4 (20%) | 0·8016 |
| Grade ≥3 redness | 0 | 0 | 1 (5%) | 1·0000 |
| Rash | 0 | 0 | 1 (5%) | 1·0000 |
| Itch | 0 | 4 (20%) | 7 (35%) | 0·1012 |
| Unsolicited adverse reactions | ||||
| Any | 4 (40%) | 6 (30%) | 6 (30%) | 0·8535 |
Data are n (%). p values are calculated with Fisher's exact test.