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A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M

NCT07183371 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-03-11

No results posted yet for this study

Summary

This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the malaria vaccine candidates R78C with Matrix-M™, and the combination of RH5.1 and R21 with Matrix-M™, in children aged 5-36 months in Burkina Faso.

Conditions

  • Malaria,Falciparum

Interventions

BIOLOGICAL

Menveo

Menveo is a tetravalent meningitis vaccine that consists of one vial of MenA powder and one vial of Men CWY solution.

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

BIOLOGICAL

Rabivax-S

Rabivax-S is an inactivated, freeze-dried, single-dose vaccine. The vaccine contains purified, inactivated rabies antigen produced using Vero ATCC CCL 81 cells as the cell substrate, Pitman Moore (PM3218) as the virus strain, and sucrose, glycine and HSA (Human Serum Albumin) as excipients

BIOLOGICAL

Avaxim 80

Avaxim 80 is an inactivated, adsorbed hepatitis A vaccine. Each immunising dose contains 80 antigen units of inactivated hepatitis A virus (GBM strain).

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

  • European Vaccine Initiative

    collaborator OTHER

  • Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR)

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Principal Investigators

  • Halidou Tinto · Institut de Recherche en Sciences de la Sante, Burkina Faso

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT07183371 on ClinicalTrials.gov