NCT06958198

A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)

A Phase Ib Age De-escalation, Open Label Study of the Safety and Immunogenicity of the Multi-stage Malaria Vaccine Candidate R21 + RH5.1 + R78C in Matrix-M™ in Adults Aged 18-35 Years and Children Aged 5-17 Months in Burkina Faso

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 5 Months – 35 Years
• Healthy volunteers: Accepted

Summary

This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.

Detailed description

There will be six study groups. Group 1 will consist of 8 adults who will receive three doses of 5 µg R21 + 10 µg RH5.1 + 10 µg R78C. Group 2 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg RH5.1. Group 3 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg R78C. Group 4 will consist of 8 children who will receive three doses of 5 µg R21 + 10 µg RH5.1 +10 µg R78C. Group 5 will consist of 8 children who will receive three doses of 5 µg R21. Group 6 will consist of 16 children who will receive three doses of 10 µg RH5.1 +10 µg R78C. All vaccinations will be given in 50 µg Matrix-M. All groups will receive their vaccinations in a 0-1-6 month regimen. Groups 1 to 4 and 6 will be recruited in a staggered process. There will be a DSMB review prior to age deescalation. There will also be three sentinel participants per group and DSMB reviews prior to each subsequent (second and third) vaccination. Group 5 can be recruited at any time and without need for sentinel participants or DSMB review.

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

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-05-06
• Last updated: 2026-03-11

Locations

1 site across 1 country: Burkina Faso