The Power of Malaria Vaccine Trials Using Controlled Human Malaria Infection.

ABSTRACT: Controlled human malaria infection (CHMI) in healthy human volunteers is an important and powerful tool in clinical malaria vaccine development. However, power calculations are essential to obtain meaningful estimates of protective efficacy, while minimizing the risk of adverse events. To optimize power calculations for CHMI-based malaria vaccine trials, we developed a novel non-linear statistical model for parasite kinetics as measured by qPCR, using data from mosquito-based CHMI experiments in 57 individuals. We robustly account for important sources of variation between and within individuals using a Bayesian framework. Study power is most dependent on the number of individuals in each treatment arm; inter-individual variation in vaccine efficacy and the number of blood samples taken pe

SUBMITTER: Coffeng LE 

PROVIDER: S-EPMC5230743 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature