NCT05357560

A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21

A Phase Ib Multi-stage Plasmodium Falciparum Malaria Vaccine Study to Assess the Safety and Immunogenicity of the Blood-stage Vaccine Candidate RH5.2 Virus-like Particle (VLP) in Matrix-M and the Pre-erythrocytic Stage Vaccine Candidate R21 in Matrix-M, Both Alone and in Combination, in Adults and Infants in the Gambia

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 5 Months – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia

Detailed description

A total of 96 volunteers will be enrolled. Adults (18-45 years) will be enrolled into groups 3 -5. Infants (5 -17 months) will be enrolled into groups 1-2 and groups 6-9. All volunteers will be given 3 doses 50 µg of Matrix-M in combination with RH5.2 VLP and/or R21 via intramuscular (IM) injection in the deltoid region of the non-dominant arm for adults and anterolateral thigh for infants. The first 2 doses will be given at months 0 and 1. Groups 2-6 and group 8 will be given the third dose at month 2, and groups 1, 7 and 9 will be given the third dose at month 6.

Conditions

• Malaria, Plasmodium Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	Matrix-M with RH5.2 VLP and/or R21	3 doses of 50 µg of Matrix-M in combination with RH5.2 VLP and/or R21 at different doses and at different timepoints

Timeline

• Start date: 2023-07-10
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-05-03
• Last updated: 2026-03-11

Locations

1 site across 1 country: The Gambia