Last Updated: 27/02/2026
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
Objectives
This study aims to:
- assess the safety and reactogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area.
- assess the humoral immunogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area.
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.
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Primary Purpose: Prevention
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Allocation: Non-Randomized
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Interventional Model: Parallel Assignment
- Masking: None (Open Label)
- Clinical trial ID: NCT06958198
Sep 2025 — Oct 2026
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