RecruitingPhase 2NCT07074665

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

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


Sponsor

University of Oxford

Enrollment

40 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called 10µg R21/50µg Matrix-M and a biological treatment called 5µg R21/50µg Matrix-M for people with malaria (plasmodium falciparum). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICAL5µg R21/50µg Matrix-M

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.

BIOLOGICAL10µg R21/50µg Matrix-M

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.


Locations(1)

Unité de Recherche Clinique de Nanoro (URCN)

Nanoro, Burkina Faso

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NCT07074665


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