Table 6.

Predicted elimination of grade 3 AEs for biomarker-based thresholds

Grade 3 AEs	MC-001 (N = 6)	MC-003 infectivity and drug controls (N = 11)	MC-003 vaccinated (N = 14)	PfSPZ-Cvac PYR (N = 6)	All studies (N = 37)
As observed in the active studies
Volunteers (%)	1 (16.7%)	5 (45.5%)	6 (42.9%)	3 (50.0%)	15 (40.5%)
Total number	4	14	16	4	38
Before or on the day of TBS positivity
Volunteers (%)	1 (16.7%)	5 (45.5%)	5 (35.7%)	2 (33.3%)	13 (35.1%)
Total number	3	10	14	2	29
Before or on the day of biomarker equivalent to ≥ 250 estimated parasites/mL
Volunteers (%)	1 (16.7%)	2 (9.1%)	1 (7.1%)	0 (0.0%)	4 (10.8%)
Total number	2	2	1	0	5
Before or on the day of any biomarker positivity
Volunteers (%)	1 (16.7%)	1 (9.1%)	0 (0.0%)	0 (0.0%)	2 (5.4%)
Total number	2	1	0	0	3

AE = adverse event; PYR = pyrimethamine; TBS = thick blood smear. Adverse events were identified here as any AE that eventually became a grade 3 AE. For example, if a participant had a grade 1 AE on day 6, but it became a grade 3 on day 8, the starting date was counted as day 6.