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Promising malaria vaccine trial launches for children in burkina faso

NCT ID NCT06618885

Vaccine Sponsor: European Vaccine Initiative Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 1 time

Summary

This study tests a new malaria vaccine called SUM-101 in 69 healthy children and infants aged 5 months to 5 years in Burkina Faso. The goal is to see if the vaccine is safe and triggers a strong immune response. Participants receive three doses, and some infants also receive a rabies vaccine as a comparison.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

39 people

The number who actually took part.

Started

Aug 2025

Finished

Apr 2026

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

5 months to 5 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: * Resident in the study area villages and participant's parent(s)/legal guardian anticipate being available for vaccination and follow-up for following last dose of vaccination. * Z-score of weight-for-age within ±2SD. Exclusion Criteria: * Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, major congenital defects, malnutrition requiring hospital admission and anaemia. * History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation. * Clinically significant laboratory abnormality as judged by the study investigator. * History of blood transfusion. * Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. * Previous vaccination with experimental malaria vaccines. * Participation in another research study/clinical trial involving receipt of an investigational medicinal product or planned use during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection (no HIV testing); asplenia; recurrent, severe infections and chronic immunosuppressant medication (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed). * Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant´s ability to participate in the trial.

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Conditions

The condition(s) this trial relates to.

malaria prevention target Plasmodium falciparum malaria prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malaria falciparum

Contacts and locations

Locations

  • Groupe de Recherche Action en Santé (GRAS)

    Ouagadougou, 06 BP 10248, Burkina Faso

More trials for these conditions

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