This is a clinical study to assess the safety and feasibility of Plasmodium vivax (P. vivax) controlled blood-stage human malaria infection (CHMI), by inoculation using a newly created source of P. vivax malaria-infected blood. 25 healthy malaria-naïve UK volunteers, aged 18 - 50, will be recruited through the five phases of the study at the CCVTM, Oxford. Volunteers will undergo primary, secondary and tertiary P. vivax blood-stage challenges, which will be induced by injection of P. vivax infected blood. After the first challenge, the optimal dose for blood-stage CHMI will be selected and used for the second and third challenges. Through each challenge period, volunteers will have blood taken at regular intervals to measure the parasite growth, quantify the sexual parasite forms and assess the immune response to P. vivax infection. Transmission of P. vivax from volunteers to the Anopheline mosquito vectors will also be assessed. In each challenge, following diagnosis, volunteers will be treated with a standard antimalarial course of oral artemether-lumefantrine (Riamet), given over 60 hours. Volunteers who take part in this study will be involved in the trial for approximately 2 years, receiving each of the three challenges at intervals of approximately 5 (and up to 9) months. Volunteers will be followed for 3 months after their last challenge.
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Number of Participants With Serious Adverse Events
Timeframe: 36 months
Number of Participants Who Developed Infection/Reached Diagnosis Criteria, Used to Select the Optimal Inoculation Dose to Take Forward to Future P. Vivax CHMI Studies Based on a Protocol-specified Algorithm
Timeframe: 3 months
Feasibility of Primary P. Vivax Blood-stage CHMI as Measured by Successful Infection (Development of Detectable Persistent Parasitaemia by Thick Film and qPCR +/- Clinical Symptoms)
Timeframe: 36 months