NCT05790889

A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.

A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 5 Months – 17 Months
• Healthy volunteers: Accepted

Summary

This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso

Detailed description

During the initial recruitment to Groups 1 and 2, participants will be randomised 1:2 to receive vaccination with the rabies control vaccination or RH5.1/Matrix-M. During recruitment to Groups 3, 4 and 5, participants will be randomised 1:2:2 to receive vaccination with rabies control vaccination, RH5.1/Matrix-M or RH5.2-VLP/Matrix-M Efficacy of vaccination will be assessed by comparing the incidence of malaria cases in the pooled control groups (Groups 1 and 3) to the incidence of malaria in each investigational vaccine group (Groups 2,4 and 5). There are three study vaccines: the IMP, 10μg RH5.1 adjuvanted with Matrix-M; 5μg RH5.2-VLP and Rabies Vaccine. Participants will receive the first vaccination of RH5.1 10μg with 50μg Matrix-M (Groups 2 and 4) or RH5.2 5μg with 50μg Matrix-M (Group 5). After approximately 4 weeks, a second dose will be administered, followed by a third and final vaccination approximately 4 weeks later (Groups 3-5) or approximately 4 months later (Groups 1-2). Second and third vaccinations will be administered at the same dose of both vaccine and adjuvant as at the initial vaccination and will be given within the window period of 5 months. Volunteers will be followed for 12 months from final vaccination. The trial is funded by EDCTP grant number RIA2016V-1649-MMVC and by a Wellcome Trust Translational Award (205981/Z/17/Z)

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	Rabies vaccine	Vaccine
BIOLOGICAL	RH5.1 10μg adjuvated with 50μg Matrix-M	Vaccine
BIOLOGICAL	RH5.2 5μg adjuvated with 50μg Matrix-M	Vaccine

Timeline

• Start date: 2023-04-03
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2023-03-30
• Last updated: 2025-03-07

Locations

1 site across 1 country: Burkina Faso