Scientists deliberately infect volunteers with malaria to study the disease
NCT ID NCT04083508
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study aims to see if it's safe and possible to give healthy Thai adults a controlled infection of P. vivax malaria through mosquito bites. Six volunteers will be infected and monitored closely. The goal is to develop a reliable model for future research on malaria and immune responses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mosquito bites infected with P. vivax malaria
- What this could lead to
- If successful, this could create a reliable model to study P. vivax malaria and test future treatments or vaccines.
- What could go wrong
- This is a very early, tiny study (6 people) focused on feasibility, not treatment. It may not lead to any direct benefit for participants or patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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5 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 cardiovascular risk assessment from Thai NCD Division, DDC, MoPH (2016) Exclusion Criteria: * History of clinical malaria. * Positive malaria PCR OR malaria film OR malaria serology (recent exposure) * History of severe allergy to mosquito bite * Presence of any medical condition (either physical or psychological) which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition) * Presence of chronic disease or chronically use of medication. * Plan to travel outside of Bangkok within the period of challenge until 3 months after. * Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin). * Use of immunoglobulins or blood products (e.g. blood transfusion) at any time in the 1 year preceding enrolment. * Venipuncture unlikely to allow blood donation according to the protocol as determined by the investigator. * Receipt of an investigational product or any vaccine in the 30 days preceding enrolment (D0), or planned receipt during the study period. * Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator. * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent, severe infections, and chronic infection. * Immunosuppressant medication within the past 6 months preceding enrolment (D0) (inhaled and topical steroids are allowed). * History of allergic disease or reactions likely to be exacerbated by malaria infection. * Female participant who is pregnant, lactating or planning pregnancy during the course of the study. * Contraindications to the use of antimalarial treatment (e.g. chloroquine or primaquine or atovaquone / proguanil, DHA piperaquine). * Use of medications known to have a potentially clinically significant interaction with antimalarial drug that will be used in this study (chloroquine or primaquine or atovaquone / proguanil, DHA/ piperaquine). * Use of medications known to cause prolongation of the QT interval as state in the section of prohibited drugs that may have effect on prolongation of the QT interval. * Known existing positive family history in both 1st AND 2nd degree relatives \< 50 years old for cardiac disease. * Family history of congenital QT prolongation or sudden death. * Any clinical condition known to prolong the QT interval. * History of cardiac arrhythmia, including clinically relevant bradycardia. * Screening ECG demonstrates a QTc interval ≥ 450 ms * Suspected or known or history of alcohol abuse * Suspected or known or history of drug abuse. * Concurrently participating in another clinical study, at any time during the study period. * Haemoglobin \< 13 g/dL in male, \< 12g/dL in female (Thai Red Cross). * Finding on safety laboratory values as defined below: * AST \> 40 U/L for male, and \> 32 U/L for female (upper normal range), or * ALT \> 41 U/L for male, and \> 33 U/L for female (upper normal range), or * Total Bilirubin \> 1.2 mg/dL, (upper normal range), or * Creatinine (Cr) \> 1.17 mg/dL for male, and \> 0.95 mg/dL for female (upper normal range), or * Abnormalities corrected calcium and magnesium blood levels, or * Fasting blood sugar (FBS) \> 100 mg/dL * Thalassaemia disease or haemoglobinopathies. * Positive for a blood borne or vector borne infectious disease (HIVI-II, HBV, HCV, Dengue, Zika, Chikungunya, Filariasis, JE, and malaria antigen, Anti HTLVI and Anti-HTLVII antibody, Syphilis test (TPHA) * Positive for COVID-19 testing as diagnosed by RT-PCR
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Faculty of Tropical Medicine
Bangkok, 10400, Thailand
More trials for these conditions
Other studies related to the condition(s) this trial covers.