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New malaria vaccine trial aims to stop recurrent fever

NCT ID NCT07373301

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Malaria Vaccine and Drug Development Center (MVDC)

    Cali, Valle del Cauca Department, 61000, Colombia

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Other studies related to the condition(s) this trial covers.