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Dose Finding Trial of R21/Matrix-M in School Children
Sponsor: University of Oxford
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
Conditions
Interventions
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.
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