drugset / Trial / NCT05357560
A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21
Phase 1
Completed
107 enrolled
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP) · collabMedical Research Council Unit, The Gambia · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia
Timeline
- Start
- 2023-07-10
- Primary completion
- 2025-12-11
- Completion
- 2025-12-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | R21 | Vaccine | 5 ug | Intramuscular |
| Subject | R21 | Vaccine | 10 ug | Intramuscular |
| Subject | RH5.2 VLP | Vaccine | 5 ug | Intramuscular |
| Subject | RH5.2 VLP | Vaccine | 10 ug | Intramuscular |
| Subject | RH5.2 VLP | Vaccine | 50 ug | Intramuscular |
| Background | Matrix-M1 Adjuvant | Other / unclassified | 50 ug | Intramuscular |