A Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso
(Acronyme : VAC091)
Prof. Halidou Tinto – Principal Investigator (IRSS-URCN, Nanoro, Burkina Faso)
Dr. Angela M. Minassian – Chief Investigator (University of Oxford, UK)
Professor Simon J Draper – Senior Laboratory Investigator
Dr Magloire Natama
This Phase IIb, double-blind, randomised, controlled clinical trial is designed to evaluate the safety, immunogenicity, and efficacy of two blood-stage malaria vaccine candidates, RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM, in healthy infants aged 5-17 months in Burkina Faso.
The trial is being conducted at a single site (IRSS-URCN, Nanoro). A total of 480 infants are enrolled and randomised into five groups receiving either one of the study vaccines or a rabies vaccine (control) on monthly or delayed dosing regimens. Each participant will be followed for 12 months after the final vaccination. The primary objective is to assess the protective efficacy of the vaccines against clinical malaria within six months of the last vaccination. The study also examines safety and immune responses over a 12-month period.
European and Developing Countries Clinical Trials Partnership (EDCTP)
(via the Multi-Stage Malaria Vaccine Consortium – MMVC)
University of Oxford
Institut de Recherche en Sciences de la Santé – Clinical Research Unit of Nanoro (IRSS-URCN), Burkina Faso
University of Oxford, UK
2023
Input your search keywords and press Enter.