Malaria vaccine trial targets kids with HIV
NCT ID NCT05385510
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the safety and immune response of the R21/Matrix-M malaria vaccine in 122 African children aged 5-36 months, some living with HIV and some without. The goal was to see if the vaccine is safe and produces an immune response in these children. The trial has been completed.
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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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122 people
The number who actually took part.
- Started
-
Jan 2023
- Finished
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Sep 2025
- 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: * The child must be 5-36 months of age at enrolment (i.e. up to the day of their third birthday). * Group 1: The child must have HIV infection (documented positive DNA PCR) with WHO stage 1 or 2 HIV disease, whether or not they are receiving ART. * Group 2: The child must not have HIV infection (absence of HIV infection must be confirmed by documented negative DNA PCR at screening). * Witnessed, signed/thumb-printed informed consent, obtained from the parent(s)/guardian(s) of the child * Parents/guardians of the child are able and willing to comply with the requirements of the protocol, in the opinion of the investigator * The child must be a permanent resident of the study area and likely to remain resident for the duration of the trial. Exclusion Criteria: * Previous receipt of a malaria vaccine. * Enrolment in another malaria intervention trial that could interfere with the results of this study. * History of severe allergic disease or reactions, including anaphylaxis or angioedema * History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines, or history of allergic reactions to previous vaccinations * Clinically significant laboratory abnormality as judged by the study clinician including haemoglobin of ≤8.0 g/dL . * Major congenital defects. * Receipt of blood transfusion, immunoglobulins and/or any blood products within the three months preceding enrolment * Malnutrition requiring hospital admission at the time of enrolment. * HIV disease of stage 3 or 4, as defined by the WHO clinical staging \[23\] * Confirmed or suspected immunosuppressive or immunodeficient state (other than due to HIV infection). o This may include asplenia, use of immunosuppressant medication within the past 6 months (except for topical steroids or short-term oral steroids (course lasting \<14 days). * Autoimmune conditions (except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease) * Any other clinically significant disease or disorder, or social situation, elicited in medical history, physical examination or laboratory tests that, in the opinion of the study clinician, may: * Put the participants at risk because of participation in the trial, or * Influence the result of the trial, or * Affect the participant's ability to participate in the trial * These may include: diseases or disorders of the pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal systems, cancer, bleeding disorders, abnormalities of screening laboratory tests or examinations * Receipt of an investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Current participation in another clinical trial if likely to affect data interpretation of this 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.
Contacts and locations
Locations
-
MRC/UVRI & LSHTM Uganda Research Unit
Entebbe, Uganda
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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