NCT07183371

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 5 Months – 36 Months
• Healthy volunteers: Accepted

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.

Detailed description

There will be three study groups, each comprising of 120 children aged between 5 and 36 months at the time of first vaccination living in a malaria endemic area and will be recruited at one site in Burkina Faso. Participants will be randomised to receive either three doses of the malaria candidate vaccines R78C/Matrix-M and three doses of a commercially available rabies vaccine, three doses of RH5.1+R78C/Matrix-M and three doses of R21/Matrix-M or six doses of commercially available control vaccines. Follow up will be for six months following the last vaccination.

Conditions

• Malaria,Falciparum

Interventions

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

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-09-19
• Last updated: 2026-03-11

Locations

1 site across 1 country: Burkina Faso