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Malaria (Plasmodium Falciparum)Phase 2NCT07074665

Dose Finding Trial of R21/Matrix-M in School Children

A Phase 2 study testing 5µg R21/50µg Matrix-M and 10µg R21/50µg Matrix-M in people with Malaria (Plasmodium Falciparum), run by University of Oxford at 1 site in Burkina Faso.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso. Read more about this study

Who is it for?
Ages 6 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Malaria (Plasmodium Falciparum)
What is being tested?
5µg R21/50µg Matrix-M and 10µg R21/50µg Matrix-M
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBurkina Faso
Study dates
18 Feb 2026to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • The child received four doses of R21/Matrix-M in the phase IIb study evaluating R21/MatrixM in Nanoro, Burkina Faso (VAC 076).
  • Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial.
  • The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study.
  • The child is a permanent resident of the study area and is expected to remain a resident for the duration of the trial.

Who cannot join

  • The child is enrolled in another malaria vaccine trial.
  • The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria vaccine.
  • The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.
  • The child has major congenital defects.
  • The child has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL.
  • The child has been administered immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
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  • The child has malnutrition requiring hospital admission.
  • The child has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.
  • Children currently meeting the WHO criteria for HIV disease of stage 3 or 4 severity. A previous history of stage 3 or 4 disease is not an exclusion. Note: There will be no routine testing for HIV. Positive diagnoses will be recorded at screening if known.
  • The child has received an investigational drug or investigational vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • The child is currently participating in another clinical trial if likely to affect data interpretation of this trial.
  • The child has 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.

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

  • Unité de Recherche Clinique de Nanoro (URCN)

    Nanoro, PO Box 11 BP 218 Ouaga CMS 11

Other trials in Burkina Faso

About this study

Official title: A Phase II Randomised Trial to Evaluate the Safety and Immunogenicity of a R21/Matrix-M Booster Vaccine at Two Different Doses in Burkinabe School Children

This trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso.

Participants (n=30-40) who have previously received four doses of the 5µg R21/50µg Matrix-M malaria vaccine in VAC 076 will be randomised to receive either 5µg R21/50µg Matrix-M or 10µg R21/50µg Matrix-M. Safety and immunogenicity of a booster at school age at these two different doses will be assessed. Participants will be followed up for one year after the booster.

This trial is co-funded by the Serum Institute of India and Coefficient Giving.

Being tested
5µg R21/50µg Matrix-M, 10µg R21/50µg Matrix-M
Keywords
Malaria Vaccine, R21/Matrix-M
Medical subject headings
Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5µg R21/50µg Matrix-MBiological

    R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. The standard paediatric dose is 5µg R21/50µg Matrix-M.

  • 10µg R21/50µg Matrix-MBiological

    R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. 10µg R21/50µg Matrix-M is the standard adult dose.

Study groups in NCT07074665
Study groupRoleWhat they receive
Group AExperimentalParticipants in this arm will be given one dose of 5µg R21/50µg Matrix-M
Receives: Biological: 5µg R21/50µg Matrix-M
Group BExperimentalParticipants in this arm will be given one dose of 10µg R21/50µg Matrix-M
Receives: Biological: 10µg R21/50µg Matrix-M

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reactogenicity

    Reactogenicity of an additional late booster of R21/Matrix-M at different doses, in school age children living in Burkina Faso. This will be measured through: 1) the occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination and 2) the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination.

    Measured: 7 days after vaccination

  2. Safety - unsolicited AEs

    Safety of an additional late booster of R21/Matrix-M at different doses, in school age children living in Burkina Faso will be assessed through the occurrence of unsolicited adverse events for 28 days following the vaccination.

    Measured: 28 days following vaccination

Secondary outcomes (3)

  1. Immunogenicity

    Humoral immunogenicity by anti-CSP antibody concentrations after school age booster of R21/Matrix-M at different doses.

    Measured: At baseline and one, six and twelve months after vaccination

  2. Safety - SAEs

    Serious adverse events (SAEs) following school age booster vaccination.

    Measured: 1 year after vaccination

  3. Safety - deaths

    Any deaths following school age booster vaccination

    Measured: 1 year after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start18 Feb 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074665
Sponsor's protocol ID
VAC101
Status last verified
Aug 2026
First submitted
23 Jun 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Yes de-identified individual participant data collected in this study may be made available to other researchers outside the main trial team. This could include data on vaccinations, health, demographics or immunology results. Any proposals for using the study data will be reviewed and approved by the sponsor trial team.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5µg R21/50µg Matrix-M and 10µg R21/50µg Matrix-M in people with Malaria (Plasmodium Falciparum), run by University of Oxford at 1 site in Burkina Faso.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reactogenicity (time frame: 7 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07074665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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