drugset / Trial / NCT06507605
Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
Phase 1
Completed
240 enrolled
Serum Institute of India Pvt. Ltd.
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a Phase 1, individually randomized, double-blind, dose escalating study designed to evaluate the safety, tolerability, and immunogenicity of Pfs230D1 conjugate vaccines, R21 nanoparticle vaccine, or their combination conjugate vaccines, formulated on Matrix-M in healthy African adults aged 18 to 50 years.
Timeline
- Start
- 2024-08-30
- Primary completion
- 2026-01-24
- Completion
- 2026-01-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pfs230D1-CRM197 | Vaccine | 6 ug | Intramuscular |
| Subject | Pfs230D1-CRM197 | Vaccine | 12 ug | Intramuscular |
| Subject | Pfs230D1-CRM197 | Vaccine | 20 ug | Intramuscular |
| Subject | Pfs230D1-CRM197 | Vaccine | 40 ug | Intramuscular |
| Subject | Pfs230D1-EPA | Vaccine | 20 ug | Intramuscular |
| Subject | R21 | Vaccine | 5 ug | Intramuscular |
| Subject | R21 | Vaccine | 10 ug | Intramuscular |