NCT05400746

A Study of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs48/45 in Matrix-M Adjuvant in the UK

A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs48/45 in Matrix-M Adjuvant in Healthy Adults Living in the UK

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open label, single-site, first-in-human, dose-escalation Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs48/45 in Matrix-M adjuvant in healthy adults living in the UK

Detailed description

Volunteers will be recruited into one of three groups (n=8-10 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford over approximately 12 months. All volunteers will receive three dose of Pfs48/45 in 50 µg Matrix-M, administered intramuscularly and given four weeks apart. Enrolment will be staggered with clinical and safety reviews, follow-up visits and monitoring via a diary card.

Conditions

• Malaria
• Plasmodium Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	Pfs48/45 in Matrix-M	Three doses of Pfs48/45 in Matrix-M at different doses

Timeline

• Start date: 2022-11-02
• Primary completion: 2023-10-19
• Completion: 2023-10-19
• First posted: 2022-06-02
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

1 site across 1 country: United Kingdom