drugset / Trial / NCT07074665
Dose Finding Trial of R21/Matrix-M in School Children
Phase 2
Recruiting
40 enrolled
University of Oxford
Institut de Recherche en Sciences de la Sante, Burkina Faso · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2026-02-18
- Primary completion
- 2026-04
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 5 ug | — |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 10 ug | — |