drugset / Trial / NCT07183371
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M
Phase 2
Active not recruiting
360 enrolled
University of Oxford
Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR) · collabEuropean Vaccine Initiative · collabEuropean and Developing Countries Clinical Trials Partnership (EDCTP) · collabInstitut de Recherche en Sciences de la Sante, Burkina Faso · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the malaria vaccine candidates R78C with Matrix-M™, and the combination of RH5.1 and R21 with Matrix-M™, in children aged 5-36 months in Burkina Faso.
Timeline
- Start
- 2025-12-15
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | R21 | Vaccine | 5 ug | Intramuscular |
| Subject | R78C | Vaccine | 10 ug | Intramuscular |
| Subject | RH5.1 | Vaccine | 10 ug | Intramuscular |
| Comparator | Avaxim 80 | Vaccine | 80 unknown | Intramuscular |
| Background | Matrix-M1 Adjuvant | Other / unclassified | 50 ug | Intramuscular |
| Comparator | Menveo | Vaccine | — | Intramuscular |
| Background | Rabivax-S | Vaccine | — | Intramuscular |