drugset / Trial / NCT05400746

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

NCT05400746 ↗

Phase 0 Terminated 17 enrolled University of Oxford
Non-randomizedParallel-groupOpen-labelPrevention

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

Timeline

Start
2022-11-02
Primary completion
2023-10-19
Completion
2023-10-19

Outcome

Outcome not reported

Stopped (Enrollment): “Significant delays in vaccine adjuvant supply due to an out of specification within the context of the grant timeline. Limited safety and immunological data could be accrued from incomplete regimens.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pfs48/45 Vaccine 10 ug Intramuscular
Subject Pfs48/45 Vaccine 50 ug Intramuscular
Background Matrix-M1 Adjuvant Other / unclassified 50 ug Intramuscular