Table 1.
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 |
Please observe different numbers of volunteers (N) in each group. The figures in cells (except bottom two lines) represent the number of events followed by the number of participants in brackets. The original clinical data underpinning this table are compiled in the Supplementary Table 3.
Solicited systemic reaction to the vaccine: solicited predefined systemic symptoms, at least possibly related.
Solicited local reaction to the vaccine: solicited predefined local symptoms, at least possibly related.
Immediate: occurring within 30 min.
Delayed: occurring between >30 min and 29 days.