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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
Sponsor: University of Oxford
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.
Official title: 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
Key Details
Gender
All
Age Range
5 Months - 36 Months
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2025-12-15
Completion Date
2026-12
Last Updated
2026-03-11
Healthy Volunteers
Yes
Conditions
Interventions
R21
A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein
RH5.1
A soluble protein vaccine against the RH5 antigen
R78C
A soluble RIPR EGF-CyRPA fusion protein vaccine
Matrix-M™
A saponin-based vaccine adjuvant
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
Menveo
Menveo is a tetravalent meningitis vaccine that consists of one vial of MenA powder and one vial of Men CWY solution.
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).
Locations (1)
Institut de Recherche en Sciences de la Sante - Clinical Research Unit of Nanoro (IRSS-URCN)
Nanoro, Burkina Faso