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RECRUITING
NCT06958198
PHASE1

A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)

Sponsor: University of Oxford

View on ClinicalTrials.gov

Summary

This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.

Official title: A Phase Ib Age De-escalation, Open Label Study of the Safety and Immunogenicity of the Multi-stage Malaria Vaccine Candidate R21 + RH5.1 + R78C in Matrix-M™ in Adults Aged 18-35 Years and Children Aged 5-17 Months in Burkina Faso

Key Details

Gender

All

Age Range

5 Months - 35 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-09-15

Completion Date

2026-10

Last Updated

2026-03-11

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

R21

A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein

BIOLOGICAL

RH5.1

A soluble protein vaccine against the RH5 antigen

BIOLOGICAL

R78C

A soluble RIPR EGF-CyRPA fusion protein vaccine

BIOLOGICAL

Matrix-M™

A saponin-based vaccine adjuvant

Locations (1)

Institut de Recherche en Sciences de la Santé

Siglé, Boulkiemdé Province, Burkina Faso