Safety Considerations for Malaria Volunteer Infection Studies: A Mini-Review.

Malaria clinical studies entailing the experimental infection of healthy volunteers with Plasmodium parasites by bites from infected mosquitos, injection of cryopreserved sporozoites, or injection of blood-stage parasites provide valuable information for vaccine and drug development. Success of these studies depends on maintaining safety. In this mini-review, we discuss the safety risks and associated mitigation strategies of these three types of experimental malaria infection. We aimed to inform researchers and regulators who are currently involved in or are planning to establish experimental malaria infection studies in endemic or non-endemic settings.