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.
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
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
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.
- Conditions
- Malaria (Plasmodium Falciparum)
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in this arm will be given one dose of 5µg R21/50µg Matrix-M Receives: Biological: 5µg R21/50µg Matrix-M |
| Group B | Experimental | Participants 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.
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
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)
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
Safety - SAEs
Serious adverse events (SAEs) following school age booster vaccination.
Measured: 1 year after vaccination
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.
- First posted20 Jul 2025
- Study start18 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria (Plasmodium Falciparum)Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Responsible party
- Sponsor
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.