Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine

Table 2 Summary of adverse events

	Cohort 1 (N=2)	Cohort 2 (N=2)	Cohort 3 (N=2)	Cohort 4^b (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%); 1^a	1 (12.5%); 1^a
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%); 1^a	1 (12.5%); 1^a

^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

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