Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

August 30, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Prevention of Malaria Transmission and Clinical Malaria
Interventions
BIOLOGICAL

R21

R21 is a portion of Pf circumsporozoite protein fused with hepatitis B surface antigen in the form of non-infectious virus-like particles (VLPs) produced in yeast cells (Hansenula) by recombinant DNA technology.

BIOLOGICAL

Pfs230D1-CRM197

Recombinant Pfs230 domain 1 (Pfs230D1; a subdomain of a surface antigen of gametocytes, gametes, and zygotes, in the mosquito stage of Pf conjugated to CRM197 and adjuvanted with 50μg of Matrix-M.

BIOLOGICAL

Pfs230D1-EPA

Recombinant Pfs230D1 conjugated to a recombinant Pseudomonas aeruginosa ExoProtein A (EPA)

OTHER

Matrix-M

Vaccine adjuvant that contains purified saponin (from Quillaja saponaria Molina) and cholesterol and phosphatidyl choline. Matrix-M will be used at a 50μg dose for vaccinations.

Trial Locations (1)

Unknown

University of Science, Technique and Technology of Bamako (Usttb), Bamako

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Serum Institute of India Pvt. Ltd.

INDUSTRY

NCT06507605 - Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults | Biotech Hunter | Biotech Hunter