A Clinical Study to Assess the Feasibility of a Controlled Human Plasmodium Vivax Malaria Infection Model Through Sporozoite Infection in Thai Adults
This study is a human challenge study to assess the feasibility and safety of controlled human malaria infection (via P. vivax sporozites) in healthy volunteers, and to develop a bank of P. vivax-infected blood for use in future controlled human P. vivax malaria infection studies. Additional objectives are to obtain data on host immune response to P. vivax infection and pre-treatment gametocytaemia. This study is funded by the UK Wellcome Trust. The grant reference number are Oxford/MORU: 212336/Z/18/Z and 212336/Z/18/A, and Mahidol University: 212336/A/18/Z and 212336/A/18/A.
• Healthy adult aged 20 to 55 years with weight more than 50 kg.
• Blood group O.
• Red blood cells positive for the Duffy antigen/chemokine receptor (DARC).
• Normal CYP2D6 genotype.
• Normal blood levels of Glucose-6-phosphate dehydrogenase (G6PDH) by the WHO definition.
• COVID-19 vaccination at least two doses of COVID-19 vaccine(s) approved by WHO.
• Agree to practice continuous effective contraception for the duration of study period until 3 months post-challenge.
• Agreement to refrain from blood donation during the course of the study and for 1 year after the end of their involvement in the study.
• Willing to take a curative antimalarial regimen following challenge.
• Willing to be admitted in the Hospital for Tropical Diseases for blood donation and clinical monitoring, until antimalarial treatment is completed and their symptoms are settling.
• Willing to reside in Bangkok for the duration of the study, until all antimalarial treatment has been completed.
• Reachable (24/7) by mobile phone during the period between challenge CHMI and completion of all antimalarial treatment.
• Able to read and write in Thai and able to answer ALL questions on the informed consent questionnaire correctly.
• Provided written informed consent to participate in the trial.
• Educational level: has at least an undergraduate degree.
• Cardiovascular risk assessment is low (less than 10% in the next 10 years according to the cardiovascular risk assessment from Thai NCD Division, DDC, MoPH (2016)