A Phase Ib/IIb Randomised Controlled Trial of the safety, immunogenicity and efficacy of a candidate malaria vaccine, R21 adjuvanted with Matrix-M (R21/MM), in 5-17 month old children in Nanoro, Burkina Faso

Objectives

To evaluate the efficacy of R21 adjuvanted with Matrix-M in healthy 5-17 month old children in a malaria endemic area.

Principal Institution

Partner Institutions

European and Developing Countries Clinical Trials Partnership (EDCTP), The Netherlands
Clinical Research Unit of Nanoro (CRUN), Burkina Faso

Rationale and Abstract

Participants will be randomised 2:1 to receive vaccination with the IMP (R21 adjuvanted with Matrix-M; Group 1 and Group 2) or control vaccination with Rabies Vaccine (Group 3). Participants and investigators will be blinded to group allocation for each participant. Efficacy of vaccination will be assessed by comparing the development of malaria between Groups 1 versus Group 2 participants.

There are two study vaccines: the IMP, R21 adjuvanted with Matrix-M; and Rabies Vaccine. Group 1 (active vaccine group) participants will receive 3 vaccinations of R21 5μg with 25μg Matrix-M, 4 weeks apart via the intramuscular route, and a booster vaccination one year following the third vaccination.

Group 2 (active vaccine group) participants will receive 3 vaccinations of R21 5μg with 50μg Matrix-M, 4 weeks apart via the intramuscular route, and a booster vaccination one year following the third vaccination.

Group 3 (control group) participants will receive three vaccinations with rabies vaccine, four weeks apart, all given intramuscularly and a fourth vaccination with rabies vaccine one year following the third vaccination.

After the first booster vaccination, participants in Groups 1 and 2 will be further randomised 2:1 to receive R21 with Matrix-M: control.

NCT number: NCT03896724

Study Design

Study type: Interventional

Enrollment: 450 participants

Allocation: Randomized

Intervention model: Parallel Assignment

Masking: Double

Primary purpose: Treatmen

Project Outputs

Article: Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after 2 years' follow-up in children in Burkina Faso: a phase 1/2b randomised controlled trial Article: Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial

External reference