Actively Recruiting
Vivax Malaria Human Infection Studies in Thailand
Led by University of Oxford · Updated on 2026-01-12
6
Participants Needed
1
Research Sites
290 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
M
Mahidol University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vivax Malaria Human Infection Studies in Thailand
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 20 to 55 years weighing 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 Glucose-6-phosphate dehydrogenase (G6PDH) levels
- At least two doses of WHO-approved COVID-19 vaccine
- Agree to use effective contraception during the study and for 3 months post-challenge
- Agree to refrain from blood donation during the study and for 1 year after
- Willing to take curative antimalarial treatment after challenge
- Willing to be admitted to Hospital for Tropical Diseases for monitoring and treatment
- Willing to live in Bangkok during the study until treatment completion
- Reachable by mobile phone 24/7 between challenge and treatment completion
- Able to read and write Thai and answer informed consent questions correctly
- Provided written informed consent
- At least undergraduate education level
- Low cardiovascular risk (less than 10% in next 10 years)
You will not qualify if you...
- History of clinical malaria
- Positive malaria PCR, film, or serology indicating recent exposure
- History of severe allergy to mosquito bites
- Any physical or psychological medical condition posing risk or interfering with study
- Chronic disease or chronic medication use
- Plans to travel outside Bangkok during challenge and 3 months after
- Use of antibiotics with antimalarial activity within 30 days before challenge
- Use of immunoglobulins or blood products in the past year
- Inability for venipuncture to allow blood donation
- Receipt or planned receipt of investigational products or vaccines impacting study
- Immunosuppressive or immunodeficient states including HIV, asplenia, splenectomy
- Immunosuppressant medication use in past 6 months (except inhaled/topical steroids)
- History of allergic diseases worsened by malaria
- Female participants who are pregnant, lactating, or planning pregnancy
- Contraindications to antimalarial drugs used in study
- Use of medications interacting with study antimalarials
- Use of medications causing QT interval prolongation
- Family history of early cardiac disease or congenital QT prolongation
- History of cardiac arrhythmia or bradycardia
- QTc interval ≥ 450 ms on ECG
- History or suspicion of alcohol or drug abuse
- Participation in another clinical study during this study
- Low hemoglobin levels (men <13 g/dL, women <12 g/dL)
- Abnormal liver, kidney, calcium, magnesium, or blood sugar lab values
- Thalassemia or hemoglobinopathies
- Positive tests for blood- or vector-borne infections including HIV, HBV, HCV, dengue, Zika, chikungunya, filariasis, JE, malaria antigen, HTLV, syphilis
- Positive COVID-19 test by RT-PCR
AI-Screening
AI-Powered Screening
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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
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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