Scientists deliberately infect volunteers with malaria to advance research
NCT ID NCT05071079
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to safely give healthy Thai adults a controlled malaria infection using frozen infected blood cells. Researchers will monitor participants closely in a hospital to find the best dose for future studies. The goal is to learn more about the malaria parasite and help develop better treatments or vaccines.
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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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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- 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: The volunteer must meet all of the following criteria to be eligible for the study: 1. Healthy Thai adult aged 20 to 55 years with weight at least 50 kg. 2. Red blood cells positive for the Duffy antigen/chemokine receptor (DARC) 3. Women only: Must practice continuous effective contraception for the duration of study period until 3 months post-challenge. 4. COVID-19 vaccination at least two doses of COVID-19 vaccines approved by WHO. 5. Agreement to refrain from blood donation during the course of the study and for 1 year after the initiation of antimalarial treatment. 6. Willing to be admitted in the Hospital for Tropical Diseases for clinical monitoring, until antimalarial treatment is completed and their symptoms are settling. 7. Willing to take a curative antimalarial treatment following CHMI. 8. Willing to reside in Bangkok and its vicinity for 2 months after malarial treatment initiation. 9. Able to read and write in Thai. 10. Provide written informed consent to participate in the trial 11. Answer all questions on the informed consent quiz correctly 12. Educational level: has at least an undergraduate degree Exclusion Criteria: The volunteer must NOT enter the study if any of the following apply: 1. Positive malaria qPCR OR malaria film 2. 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) 3. Presence of chronic disease or chronically use of medication 4. 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) 5. Use of immunoglobulins or blood products (e.g. blood transfusion) at any time in the 1 year preceding enrolment 6. Receipt of an investigational product, any vaccine in the 30 days preceding enrolment (D0), or planned receipt during the study period 7. 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. 8. Any confirmed, or suspected immunosuppressive, or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent, severe infections, and chronic infection 9. Immunosuppressant medication within the past 6 months preceding enrolment (D0) (inhaled and topical steroids are allowed) 10. History of allergic disease or reactions likely to be exacerbated by malaria infection 11. Female participant who is pregnant as evidenced by positive beta-human chorionic gonadotropin (β-HCG) test, lactating, or planning pregnancy during the course of the study 12. Contraindications to the use of antimalarial treatment (e.g. chloroquine, atovaquone / proguanil or dihydroartemisinin/piperaquine) 13. Use of medications known to have a potentially clinically significant interaction with the antimalarial drug that will be used in this study (chloroquine, atovaquone / proguanil or dihydroartemisinin/piperaquine) 14. Known existing positive family history in both 1st AND 2nd degree relatives \< 50 years old for cardiac disease 15. History of cardiac arrhythmia, including clinically relevant bradycardia 16. Family history of congenital QT prolongation or sudden death 17. Any clinical condition, including using medications, known to prolong the QT interval. 18. Screening electrocardiogram (ECG) demonstrates a QTc interval ≥ 450 ms. 19. Suspected or known or history of alcohol abuse 20. Suspected or known or history of drug abuse. 21. Concurrently participating in another clinical study, at any time during the study period 22. Haemoglobin \< 11 g/dL 23. Positive hepatitis B surface antigen or seropositive for hepatitis C virus 24. Finding on safety laboratory values as defined below: * Abnormal AST (AST \> 40 U/L for male, and \> 32 U/L for female \[upper normal range\]) * Abnormal ALT (ALT \> 41 U/L for male, and \> 33 U/L for female \[upper normal range\]) * Abnormal serum creatinine (Scr) (Creatinine \[Cr\] \> 1.17 mg/dL for male, and \> 0.95 mg/dL for female \[upper normal range\]) * Abnormalities corrected calcium and magnesium blood levels 25. Blood group Rhesus negative 26. Blood incompatibility to the inoculum 27. Positive for COVID-19 diagnosed by RT-PCR
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Faculty of Tropical Medicine
RECRUITINGBangkok, 10400, Thailand
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Other studies related to the condition(s) this trial covers.
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- Scientists deliberately infect volunteers with malaria to study the disease