Table 2.
Cohort 1 (N=2) |
Cohort 2 (N=2) |
Cohort 3 (N=2) |
Cohort 4b (N=2) | Total (N=8) |
|
---|---|---|---|---|---|
Number of subjects with at least one adverse event [n (%)]; number of adverse events | |||||
Any adverse event | 2 (100%); 13 | 1 (50%); 3 | 2 (100%); 5 | 2 (100%); 23 | 7 (87.5%); 44 |
Adverse event of moderate intensity | 1 (50%); 3 | 0 (0%); 0 | 1 (50%); 1 | 2 (100%); 3 | 4 (50%); 7 |
Adverse event of severe intensity | 0 (0%); 0 | 0 (0%); 0 | 0 (0%); 0 | 1 (50%); 1a | 1 (12.5%); 1a |
Adverse event related to GAP vaccine | 0 (0%); 0 | 0 (0%); 0 | 1 (50%); 1 | 2 (100%); 14 | 3 (37.5%); 15 |
Serious adverse event | 0 (0%); 0 | 0 (0%); 0 | 0 (0%); 0 | 1 (50%); 1a | 1 (12.5%); 1a |
aThe severe adverse event (joint dislocation) also met the criteria for a serious adverse event since it required hospitalization and surgery. This event was not considered related to the GAP vaccine. bOne subject in cohort 4 (subject 7) was confirmed to be positive for influenza B at the time of antimalarial treatment