This is a single-centre, open-label study using P. falciparum-induced blood stage malaria
(IBSM) infection to assess the infectivity of sexual life cycle stages of the malaria
parasite (gametocytes) to mosquito vectors. Previous clinical studies have shown that
treatment of participants with the antimalarial drug piperaquine, in addition to effectively
clearing asexual (pathogenic) stages of the malaria life cycle, induces the production of
gametocytes in the blood. The propensity of piperaquine to induce gametocytemia will be
employed in this study to assess gametocyte infectivity to Anopheles mosquitoes. For this
purpose, experimental mosquito feeding directly on participants and artificial membrane
mosquito feeding will be performed. The study will be conducted in 3 cohorts (n=2 per
cohort). Subsequent cohorts will not commence until at least after day 28 of the previous
cohort and review by Safety Review Team. This interval will also allow cohorting of
experimental infection of mosquitoes to optimise logistics and enable iterative improvements
in the system if applicable.
Phase:
Phase 1
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
Army Malaria Institute, Australia Clinical Network Services (CNS) Pty Ltd Q-Pharm Pty Limited QIMR Berghofer Medical Research Institute Sullivan Nicolaides Pathology