drugset / Trial / NCT06958198
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
Phase 1
Recruiting
56 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 · collabWellcome Trust · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.
Timeline
- Start
- 2025-09-15
- Primary completion
- 2026-10
- Completion
- 2026-10
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 |
| Background | Matrix-M1 Adjuvant | Other / unclassified | 50 ug | Intramuscular |