Actively Recruiting
A Controlled Human Vivax Malaria Infection Study Through Inoculation of Infected Erythrocytes
Led by University of Oxford · Updated on 2026-01-12
48
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
W
Wellcome Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objectives of this study are to assess the safety and feasibility of blood-stage controlled human P. vivax malaria infection (CHMI) in healthy adult Thai volunteers through experimental injection of cryopreserved P. vivax infected erythrocytes, and to choose the optimal inoculation dose for future P. vivax CHMI studies. In this study, blood-stage CHMI will be conducted in 8 volunteers per inoculum stock who will each be infected with P. vivax by experimental injection with cryopreserved P. vivax infected erythrocytes, which were collected from the controlled human Plasmodium vivax malaria infection model through experimental sporozoite infection in Thai adults (NCT04083508) . There are currently 4 stocks of inocula from 6 volunteers in the NCT04083508 study, which have differing quantities and stages of parasites. The total number of volunteers of this study will be up to 48 (8 volunteers per inocula stock). The volunteers will be monitored closely as in-patients in the Hospital for Tropical Diseases, and will be treated according to the Research Proposal. 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.
CONDITIONS
Official Title
A Controlled Human Vivax Malaria Infection Study Through Inoculation of Infected Erythrocytes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Thai adults aged 20 to 55 years weighing at least 50 kg
- Red blood cells positive for Duffy antigen/chemokine receptor (DARC)
- Women must use effective contraception throughout the study and for 3 months after challenge
- At least two doses of WHO-approved COVID-19 vaccines received
- Agree not to donate blood during the study and for 1 year after antimalarial treatment
- Willing to stay admitted in the Hospital for Tropical Diseases during monitoring and treatment
- Willing to take curative antimalarial treatment after challenge
- Willing to live in Bangkok area for 2 months after starting malarial treatment
- Able to read and write Thai
- Provide written informed consent
- Correctly answer all informed consent quiz questions
- Have at least an undergraduate degree
You will not qualify if you...
- Positive malaria test by qPCR or blood film
- Any physical or psychological medical condition risking participant safety or study results
- Chronic diseases or chronic medication use
- Use of antibiotics with antimalarial activity in last 30 days
- Use of immunoglobulins or blood products within past year
- Receipt of investigational products or vaccines in past 30 days or planned during study
- Prior investigational vaccine affecting trial data or P. vivax
- Immunosuppressive or immunodeficient conditions, including HIV, asplenia, severe infections
- Immunosuppressant medication within past 6 months (except inhaled/topical steroids)
- History of allergic diseases worsened by malaria
- Pregnancy, lactation, or planning pregnancy during study
- Contraindications to antimalarial drugs used in study
- Use of medications interacting with study antimalarials
- Family history of cardiac disease or arrhythmias under 50 years
- History of cardiac arrhythmia or clinically relevant bradycardia
- Family history of congenital QT prolongation or sudden death
- Clinical conditions or medications prolonging QT interval
- Screening ECG with QTc interval ≥ 450 ms
- History or suspicion of alcohol or drug abuse
- Participation in another clinical study during this study
- Hemoglobin below 11 g/dL
- Positive hepatitis B surface antigen or hepatitis C serology
- Abnormal liver enzymes, kidney function, calcium, or magnesium levels
- Blood group Rhesus negative
- Blood incompatibility with inoculum
- Positive COVID-19 test by RT-PCR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Faculty of Tropical Medicine
Bangkok, Thailand, 10400
Actively Recruiting
Research Team
N
Nicholas Day, MD
CONTACT
J
Jetsumon Sattabongkot Prachumsri, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here