Last Updated: 27/02/2026

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

Objectives

This Phase IIb trial evaluates the safety, immunogenicity, and efficacy of 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.

Principal Institution

Research Institute of Health Sciences (IRSS), Burkina Faso

Principal Investigators / Focal Persons

Halidou Tinto

Partner Institutions

European Vaccine Initiative (EVI), Germany
Federal Ministry of Research, Technology and Space (BMFTR), Germany

Rationale and Abstract

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. 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.

Study Design