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Last Updated: 30/04/2024
Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant in healthy adults in the UK
Objectives
The objective of this study is to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.
Principal Institution
Principal Investigators / Focal Persons
Rationale and Abstract
This is an open-label, single-center, non-randomized, first-in-human Phase Ia study. 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.
Study Design
Study type: Interventional
Enrollment: 25 participants
Primary purpose: Prevention
Allocation:Non-Randomized
Interventional Model: Parallel assignment
Masking: Open label
NCT number: NCT05270265
Phase: Phase I
External reference
Thematic Categories
Date
Feb 2022 — Sep 2023
Project Site
Deep Dives
Related Resources
