Promising malaria vaccine candidates enter key trial in african children
NCT ID NCT07183371
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two experimental malaria vaccines in 360 children aged 5 to 36 months in Burkina Faso, a country where malaria is common. The vaccines aim to prevent malaria caused by the Plasmodium falciparum parasite. Researchers will check how safe the vaccines are, how well they trigger the immune system, and whether they reduce cases of malaria over six months after the final dose.
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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 360 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 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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5 to 36 months
- 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: Only participants who meet all the inclusion criteria will be enrolled into the trial: * Healthy infant aged 5-36 months at the time of first study vaccination * Parent/guardian provides signed/thumb-printed informed consent * Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and the duration of follow-up Exclusion Criteria: The participant may not enter the trial if ANY of the following apply: * Clinically significant congenital abnormalities as judged by the PI or other delegated individual. * Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual. * Weight-for-age Z score of less than -3 or other clinical signs of malnutrition. * History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Sickle cell disease. * Clinically significant laboratory abnormality at grade 2 or above as judged by the PI or other delegated individual. * Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. * Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 28 days following each study vaccination. * History of vaccination with another malaria vaccine. * Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period. * Known maternal HIV infection (no testing will be done by the study team). * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (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. The following adverse events associated with vaccine immunisation constitute absolute contraindications to further administration of vaccine. If any of these events occur during the study, the participant must be withdrawn and followed until resolution of the event, as with any adverse event: • Anaphylactic reaction following administration of vaccine. The following adverse events constitute contraindications to administration of vaccine at that point in time; if any one of these adverse events occurs at the time scheduled for vaccination, the participant may be vaccinated at a later date, or withdrawn at the discretion of the Investigator. The participant must be followed until resolution of the event as with any adverse event: * Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever or symptoms suggestive of possible COVID-19 disease). All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection without fever, i.e. axillary temperature \< 37.5°C. * Temperature of \>37.5°C (99.5°F) at the time of vaccination.
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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.
Contacts and locations
Locations
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Institut de Recherche en Sciences de la Sante - Clinical Research Unit of Nanoro (IRSS-URCN)
Nanoro, Burkina Faso
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Other studies related to the condition(s) this trial covers.
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