NCT05270265

Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine

A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Vivax Malaria Vaccine Candidate Pvs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.

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 18 months. All volunteers will receive three doses of Pvs25-IMX313 in Matrix-M1, 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, Vivax

Interventions

Type	Name	Description
BIOLOGICAL	Pvs25-IMX313/Matrix-M1	Three doses of Pvs25-IMX313 in Matrix-M1 at different concentrations

Timeline

• Start date: 2022-02-09
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-03-08
• Last updated: 2026-01-15
• Results posted: 2026-01-15

Locations

1 site across 1 country: United Kingdom