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

NCT07074665 | Recruiting Phase 2 DMC

• 1 other identifier: VAC101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Malaria (Plasmodium Falciparum)

Keywords

Malaria Vaccine; R21/Matrix-M

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  28 days following vaccination

Secondary Outcomes (3)

• Immunogenicity

  At baseline and one, six and twelve months after vaccination

• Safety - SAEs

  1 year after vaccination

• Safety - deaths

  1 year after vaccination

Study Arms (2)

Group A

EXPERIMENTAL

Participants in this arm will be given one dose of 5µg R21/50µg Matrix-M

Biological: 5µg R21/50µg Matrix-M

Group B

EXPERIMENTAL

Participants in this arm will be given one dose of 10µg R21/50µg Matrix-M

Biological: 10µg R21/50µg Matrix-M

Interventions

5µg R21/50µg Matrix-M BIOLOGICAL

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.

Group A

10µg R21/50µg Matrix-M BIOLOGICAL

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.

Group B

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator

Study Sites (1)

Unité de Recherche Clinique de Nanoro (URCN)

Nanoro, PO Box 11 BP 218 Ouaga CMS 11, Burkina Faso

RECRUITING

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Central Study Contacts

Mehreen Datoo

CONTACT

+44 7859035715; mehreen.datoo@ndm.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 20, 2025
• Study Start: February 18, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

BU (1)