New malaria vaccine trial aims to stop recurrent fever
NCT ID NCT07373301
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental vaccine called PvCS/Montanide ISA-51 to see if it can protect against P. vivax malaria, a major cause of recurrent fever and anemia. 72 healthy adults in Colombia will receive either the vaccine or a placebo, then be exposed to infected mosquitoes under medical supervision. Researchers will monitor who gets infected and track side effects to determine if the vaccine is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PvCS/Montanide ISA-51 vaccine (a synthetic peptide from the malaria parasite combined with an immune-boosting adjuvant)
- What this could lead to
- If successful, this could lead to the first licensed vaccine against P. vivax malaria, preventing recurrent fever and illness in tropical regions.
- What could go wrong
- This is a Phase 2 trial with only 72 participants, so results may not apply to larger populations. The vaccine may not provide strong or lasting protection, and side effects like injection-site reactions are possible.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
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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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 Age 18-50 years, male or female. Healthy adults, as determined by medical history, physical examination, and screening laboratory tests. Able and willing to provide written informed consent prior to any study procedure. Available for the full duration of the study, including follow-up through 12 months post-challenge. Group-specific criteria: Malaria-naïve cohort: No prior malaria infection or residence in malaria-endemic areas; negative malaria serology at screening. Semi-immune cohort: Residence ≥ 5 years in a P. vivax-endemic area and documented or self-reported prior malaria exposure. Screening negative for HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus antibodies. For women of childbearing potential: Negative pregnancy test at screening and prior to each vaccination and/or CHMI. Commitment to use effective contraception (hormonal, IUD, barrier methods, or abstinence) from screening through the end of follow-up. Willingness to comply with all study procedures, including repeated blood sampling, controlled human malaria infection (CHMI), and inpatient or outpatient monitoring as required. Exclusion Criteria Previous participation in any malaria vaccine clinical trial or any controlled human malaria infection (CHMI) study. History of severe allergic reactions, including anaphylaxis, to vaccines or vaccine components such as Montanide ISA-51 VG, adjuvants, or synthetic peptides. Clinically significant acute or chronic medical conditions that may increase risk or interfere with study participation, including but not limited to: Cardiovascular disease Hepatic or renal impairment Neurological or psychiatric disorders Autoimmune diseases Hematologic abnormalities Immunodeficiency or immunosuppressive conditions Use of immunosuppressive therapies, systemic corticosteroids, antimalarial medications, or other agents that may interfere with vaccine immune responses within 30 days prior to enrollment. Receipt of immunoglobulins or blood products within 3 months prior to screening. Pregnancy or breastfeeding at screening or planned pregnancy during the study period. Participation in another clinical trial of an investigational product or device within 30 days prior to enrollment or planned participation during the study. Any clinically significant abnormality on screening laboratories, ECG, or physical examination that, in the investigator's judgment, could: Pose a safety risk, Confound study results, or Impair adherence to study procedures. Any condition or circumstance that, in the investigator's opinion, could compromise volunteer safety or the integrity of the trial.
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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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Malaria Vaccine and Drug Development Center (MVDC)
Cali, Valle del Cauca Department, 61000, Colombia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a single dose of tafenoquine finally cure vivax malaria in southeast asia?
- Malaria prevention study pulled before it began
- Could targeted drug dosing stamp out malaria in thai hotspots?
- One shot to stop malaria? new injection tested in rwanda
- New malaria vaccine candidate enters human trial in thailand
- Could a simple device keep mosquitoes away better than spraying?