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RECRUITING
NCT07074665
PHASE2

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

Sponsor: University of Oxford

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-18

Completion Date

2027-03

Last Updated

2026-02-23

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

5µg 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.

BIOLOGICAL

10µg 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