Sample size
malaria-exposed
One hundred and thirty-five (135) healthy participants were planned for 3 cohorts of malaria-exposed African adults and children as described above. The sample size was calculated to address the primary objective (safety). In each cohort (assuming n = 29 evaluable participants in the BK-SE36/CpG arm), the probability of seeing at least one SAE was 95% if the underlying risk of an SAE was 10%. If the risk of an SAE was 5% then the probability of seeing at least one SAE was 77%. With 87 vaccinees the probability of detecting at least one SAE was >99% if the risk was 10%; 99% if the risk was 5% and 58% if the risk was 1%.