Can a single shot of a genetically weakened malaria parasite train the body to fight off the real thing?
NCT ID NCT07730177
First seen Jul 28, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This trial tests a new malaria vaccine, PfSPZ-LARC2, made from live but genetically weakened malaria parasites that stop developing in the liver and never reach the bloodstream. The goal is to see if a single dose can safely and effectively protect healthy adults in Burkina Faso from malaria when they are later exposed to the parasite under controlled conditions. The vaccine is designed to trigger a strong immune response without causing actual malaria illness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a genetically weakened malaria vaccine called PfSPZ-LARC2, given as a single injection
- What this could lead to
- If successful, this could pave the way for a single-dose vaccine that provides strong, lasting protection against malaria.
- What could go wrong
- This is an early phase 1 trial with only 45 participants, so safety and efficacy are not yet established. The vaccine is genetically modified, and long-term effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 to 50 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: 1. Healthy males and females, based on clinical and laboratory findings (note: an effort will be made to recruit roughly equal numbers of males and females, although a balanced sex ratio is not required) 2. From 18 to 50 years of age 3. Adults with a Body Mass Index (BMI) 18 to 30 Kg/m\^2 4. Residence in the study area for the duration of the study 5. Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study 6. Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period 7. Agreement to provide contact information of a third-party household member or close friend to study team 8. Agreement not to participate in another clinical trial during the study period 9. Agreement not to donate blood during the study period (until final clearance is completed) 10. Able and willing to complete the study visit schedule over the study follow up period 11. Willingness to undergo HIV, hepatitis B (HBV), hepatitis C (HCV), and sickle cell testing 12. Able to demonstrate their understanding of the study by responding correctly to 18 out of 20 true/false statements (in a maximum of two repeat attempts for those who failed to pass in the first attempt) 13. Signed written informed consent, in accordance with local practice 14. Has not been treated with any antimalarial medication for at least two weeks before the initial clearance treatment. 15. Female volunteers must be non-pregnant (as demonstrated by a negative urine pregnancy test) and provide consent / assent of their willingness to take protocol-defined measures not to become pregnant during the study and safety follow-up period. Acceptable measures to not become pregnant include oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner, or sterile sexual partner during the entire study. Women with a history of surgical or chemical sterilization (e.g., tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider. 16. Ability to complete pre-vaccination drug clearance without significant untoward effects. Exclusion Criteria: 1. Unable to provide informed consent including inability to pass the test of understanding 2. Receipt of a malaria vaccine in a prior clinical trial 3. History of a splenectomy or sickle cell disease. 4. History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache 5. Current use of systemic immunosuppressant pharmacotherapy 6. Receipt of a live vaccine within 4 weeks of first immunization or of 3 or more non-live vaccines within 2 weeks of first immunization 7. Women who are breast-feeding, pregnant or planning to become pregnant during the study period 8. Known allergy to artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DHA-P), or any component of the investigational products 9. History of anaphylaxis or other life-threatening reaction to a vaccine 10. Participation in any study involving investigational vaccine or drug within 4 weeks before enrollment that in the estimation of the site PI might adversely affect the individual's safety or the quality of data to be collected 11. Evidence of increased cardiovascular disease risk; defined as \>10% five-year risk by non-laboratory method 12. Plan to participate in another investigational vaccine/drug research during the study 13. Plan for major surgery between enrollment until last study visit 14. Use or planned use of any drug with anti-malarial activity that would precede or coincide with vaccination through to 56 days after controlled human malaria infection (CHMI) 15. Anticipated use of medications known to cause drug interactions with DHA-P (antiarrhythmics, neuroleptics, macrolide antibiotics, fluoroquinolones, imidazole and triazole antifungal agents, quinine, halofantrine, pentamidine and saquinavir, certain non-sedating antihistamines, all of which can affect QT intervals ) or AL (the same list of drugs affecting QT intervals plus rifampin, carbamazepine, phenytoin, St. John's wort and antiretroviral drugs) 16. Positive HIV, HBsAg or HCV serology 17. Positive sickle cell trait or disease testing 18. History of or evidence for other chronic disease conditions including cancer, diabetes, renal failure, hypertension, and tuberculosis 19. History of arrythmias or cardiac disease, or an abnormal electrocardiogram, defined as one showing prolonged QT interval, pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram 20. Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving (grade 1 abnormalities are allowed) 21. Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse affecting social function) that, in the judgment of the site PI, impairs the participant's ability to give informed consent, increases the risk to the participant of participation in the study, affects the ability of the participant to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study 22. Inability to complete a course of malaria treatment before receipt of investigational product
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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.
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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Groupe de Recherche Action en Santé (GRAS)/Unité de Recherche Clinique de Sabou
Ouagadougou, 06, Burkina Faso
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