Table 3. Severe or potentially life threatening adverse adverse events.*.
| Placebo (P) (n = 32) n (%) | M/M/P/P (T1) (n = 38) n (%) | MP/MP (T2) (n = 38) n (%) | D/D/M/M (T3) (n = 38) n (%) | D/D/MP/MP (T4) (n = 38) n (%) | Total (N = 184) N (%) | |
|---|---|---|---|---|---|---|
| Abnormal weight loss | 1 (3.1%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (5.3%) | 3 (1.6%) |
| Acute tonsilitis | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2.6%) | 1 (0.5%) |
| Haematuria | 0 (0%) | 0 (0%) | 1 (2.6%) | 0 (0%) | 0 (0%) | 1 (0.5%) |
| Decreased haemoglobin | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2.6%) | 0 (0%) | 1 (0.5%) |
| Headache | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2.6%) | 0 (0%) | 1 (0.5%) |
| Peripheral neuropathy | 0 (0%) | 1 (2.6%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (0.5%) |
| Neutropenia | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2.6%) | 1 (0.5%) |
| Pelvic inflammatory disease | 0 (0%) | 0 (0%) | 1 (2.6%) | 0 (0%) | 0 (0%) | 1 (0.5%) |
| Soft tissue injury | 1 (3.1%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (0.5%) |
| Substance-induced psychotic disorder | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2.6%) | 1 (0.5%) |
| Total | 2 (6.3%) | 1 (2.6%) | 2 (5.3%) | 2 (5.3%) | 5 (13.2%) | 12 (6.5%) |
* All adverse events were graded as severe, apart from 1 potentially life threatening adverse event due to a decreased haemoglobin. There were no fatal events. M/M/P/P: MVA prime, sequential gp140 boost; MP/MP: concurrent MVA/gp140; D/D/M/M: DNA prime, sequential MVA boost; D/D/MP/MP: DNA prime, concurrent MVA/gp140 boost).