Table 1 Distribution of solicited and unsolicited adverse reactions and distribution of all assessed adverse events, grouped by blinded vaccination 1–3 and the optional 4th booster vaccination.
MSP1 | Vaccination 1–3 (blinded) | Vaccination 4 (optional—open) | ||||||
|---|---|---|---|---|---|---|---|---|
SumayaVac-1 | GLA-SE | 0.9% NaCl | SumayaVac-1 | |||||
25 µg | 50 µg | 150 µg | 5 µg | 1 ml | 25 µg | 50 µg | 150 µg | |
N = 6 | N = 12 | N = 6 | N = 4 | N = 4 | N = 5 | N = 9 | N = 4 | |
Solicited systemic reaction | 7 (2) | 15 (7) | 8 (3) | 1 (1) | 2 (1) | 0 (0) | 4 (1) | 0 (0) |
Immediate | 1 (1) | 2 (1) | 1 (1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Delayed | 6 (3) | 13 (7) | 7 (3) | 1 (1) | 2 (1) | 0 (0) | 4 (1) | 0 (0) |
Solicited local reaction | 15 (5) | 58 (12) | 12 (4) | 10 (4) | 11 (3) | 3 (3) | 8 (5) | 3 (3) |
Immediate | 5 (3) | 4 (4) | 1 (1) | 1 (1) | 3 (2) | 0 (0) | 0 (0) | 1 (1) |
Delayed | 10 (3) | 54 (12) | 11 (4) | 9 (4) | 8 (4) | 3 (3) | 8 (5) | 2 (2) |
Unsolicited adverse events | 63 (6) | 147 (12) | 55 (6) | 43 (4) | 33 (33) | 19 (5) | 30 (9) | 15 (4) |
All adverse events | 85 (6) | 220 (12) | 75 (6) | 54 (4) | 46 (4) | 22 (5) | 42 (9) | 18 (4) |
Serious | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Permanent | 0 (0) | 1 (1) | 1 (1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Mild/moderate/severe | 73/12/0 | 209/10/1 | 72/3/0 | 51/3/0 | 46/0/0 | 17/5/0 | 38/4/0 | 17/0/1 |
Related/unrelated | 54/31 | 160/60 | 55/20 | 33/21 | 35/11 | 15/7 | 33/9 | 14/4 |
