CompletedNot Applicable

Vivax Malaria Human Infection Studies in Thailand

Thailand5 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 range

20 Years – 55 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 completion2025-09-12

View on ClinicalTrials.gov More Plasmodium Vivax Infection trials

Plain-language summary

Who can participate

Age range

20 Years – 55 Years

Sex

ALL

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