drugset / Trial / NCT07147400
Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults
Phase 2
Active not recruiting
1200 enrolled
Serum Institute of India Pvt. Ltd.
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a Phase 2, randomized, double-blind, controlled study designed to evaluate the safety, tolerability, immunogenicity, vaccine efficacy, and functional activity of Pfs230D1-CRM197 conjugate vaccine with R21 nanoparticle vaccine formulated on Matrix-M1. Participants (9-50 years of age) will be drawn from Bancoumana and Donéguébougou, Mali and the surrounding areas.
Timeline
- Start
- 2025-08-22
- Primary completion
- 2027-11
- Completion
- 2027-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pfs230D1-CRM197 | Vaccine | 6 ug | Intramuscular |
| Subject | R21 | Vaccine | 10 ug | Intramuscular |
| Subject | Rabivax-S | Vaccine | — | Intramuscular |
| Background | Matrix-M1 | Other / unclassified | 50 ug | Intramuscular |