NCT05385471

A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Malaria Candidate Vaccines RH5.1 in Matrix-M and R78C in Matrix-M in Healthy UK Adults

A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Malaria Candidate Vaccines RH5.1 in Matrix-M and R78C in Matrix-M, Both Alone and in Combination, in Healthy UK Adults

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-centre Phase I P. falciparum blood-stage vaccine trial to assess the safety and immunogenicity and efficacy of the candidate malaria vaccines R78C and RH5.1 formulated in adjuvant Matrix-M

Detailed description

Volunteers will be recruited into one of four groups (n=8+1 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. Volunteers in groups 1, 2 and 4 will be followed up for a total of approximately 12 months. There will be 3 sentinel participants in each group (and for each successive vaccination), which will require an independent safety review prior to each successive vaccination. Group 3 is not a first-in-human group and so can be recruited at any time and participants will be followed up for a total of approximately 20 months from first vaccination. All volunteers will be given 10 µg R78C and/or 10 µg RH5.1 soluble protein in combination with 50 µg of Matrix-M via intramuscular (IM) injection in the deltoid region of the non-dominant arm.

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	Matrix M with R78C and/or RH5.1	50 µg of Matrix-M adjuvant with R78C and/or RH5.1 at different doses and timepoints

Timeline

• Start date: 2023-01-13
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2022-05-23
• Last updated: 2025-04-01

Locations

1 site across 1 country: United Kingdom