The study presented here is a Phase 1 exploratory study that was conducted in four sequential single subject cohorts (ANZCTR Trial ID: ACTRN12617001502325) and performed at Q-Pharm Pty Ltd, Brisbane, Australia and the Apheresis Unit at the Royal Brisbane and Women’s Hospital (RBWH), Australia between October 2017 and May 2019. The primary objective of the study was to determine the safety of the P. vivax infection in healthy subjects following inoculation with blood-stage parasites, and the safety of apheresis for collection of P. vivax parasites from experimentally infected subjects. Secondary objectives were to assess the feasibility of apheresis as a method of harvesting, concentrating and subsequently cryopreserving P. vivax parasites from healthy subjects. Exploratory objectives were to evaluate the potential for apheresis to be used as a method for producing a P. vivax human malaria parasite bank, to evaluate the transmission of P. vivax gametocytes to mosquitoes and to collect and store plasma and peripheral blood mononuclear cells harvested using apheresis.

Specific modifications to the study protocol, such as the apheresis procedure, were required between subjects in an attempt to optimize the procedure and meet the objectives. All changes made between subjects were based on the findings from previous subjects.

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