Clinical Trial

Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-28; most recent amendment 2026-07-06.
Status change: Recruiting → Active, Not Recruiting 2026-07-06
Status change: Not Yet Recruiting → Recruiting 2025-11-16
Trial Details
NCT Number NCT07147400
Lead Sponsor Serum Institute of India Pvt. Ltd.
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Prevention of Malaria Transmission and Clinical Malaria
Enrollment 1,200 participants
Start Date 2025-08-22
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-08