Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Malaria vaccine trial targets kids with HIV

NCT ID NCT05385510

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

122 people

The number who actually took part.

Started

Jan 2023

Finished

Sep 2025

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 to 36 months

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: * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HIV infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.