RecruitingNot Applicable

Vivax Malaria Human Infection Studies in Thailand

Thailand6 participantsStarted 2020-10-05

Plain-language summary

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.

Who can participate

Age range20 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). * CYP2D6 alleles consistent with normal metaboliser status * 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 cardiovascu…

What they're measuring

Successful infection of controlled P. vivax sporozoite human challenge

Timeframe: up to 21 days after challenge

(Serious) Adverse Event(s) occurrences of controlled P. vivax sporozoite human challenge

Timeframe: up to 90 days after challenge

Collection and freezing down of up to 250 mL P. vivax-infected blood from each of the 6 volunteers.

Timeframe: up to 21 days after challenge

Trial details

NCT IDNCT04083508

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Nicholas Day, MD

+66-(0)2-3549170 nickd@tropmedres.ac

View on ClinicalTrials.gov More Plasmodium Vivax Infection trials

Plain-language summary

Who can participate

Age range20 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Successful infection of controlled P. vivax sporozoite human challenge

Timeframe: up to 21 days after challenge

(Serious) Adverse Event(s) occurrences of controlled P. vivax sporozoite human challenge

Timeframe: up to 90 days after challenge

Collection and freezing down of up to 250 mL P. vivax-infected blood from each of the 6 volunteers.

Timeframe: up to 21 days after challenge