The Power of Malaria Vaccine Trials Using Controlled Human Malaria Infection

Author Summary Controlled human malaria infection (CHMI) in healthy human volunteers is an important and powerful tool in clinical malaria vaccine development. However, to obtain meaningful estimates of protective efficacy, it is important to include an appropriate minimum number of participants, while minimizing the risks and burden for volunteers. Existing power calculations have limited value due to important influential assumptions. To optimize power calculations for malaria vaccine trials, we developed a non-linear, Bayesian statistical model for parasite kinetics as measured by quantitative real-time polymerase chain reaction, using ex…