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

NCT06958198 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Malaria,Falciparum

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

Sponsors & Collaborators

  • Institut de Recherche en Sciences de la Sante, Burkina Faso

    collaborator OTHER_GOV

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Wellcome Trust

    collaborator OTHER

  • European Vaccine Initiative

    collaborator OTHER

  • Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR)

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Burkina Faso

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06958198 on ClinicalTrials.gov