R21/Matrix-M in African Children Against Clinical Malaria

Phase 3 Active not recruiting 4800 enrolled University of Oxford Ifakara Health Institute Clinical Trial Facility, Bagamoyo Research and Training Centre, PO Box 74, Bagamoyo, Tanzania · collab Institut de Recherche en Sciences de la Sante, Burkina Faso · collab Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest · collab KEMRI-Wellcome Trust Collaborative Research Program · collab London School of Hygiene and Tropical Medicine · collab Malaria Research and Training Center, Bamako, Mali · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

A Phase III randomized controlled multi-centre trial to evaluate the efficacy of the R21/Matrix-M vaccine in African children against clinical malaria

Timeline

Start: 2021-04-29
Primary completion: 2023-03-21
Completion: 2028-04

Outcome

Met primary endpoint

paper 12-month vaccine efficacy was 75% (95% CI 71-79; p<0·0001) at the seasonal sites and 68% (61-74; p<0·0001) at the standard sites PMID 38310910 ↗

Publications

Datoo MS, Dicko A, Tinto H, Ouedraogo JB, Hamaluba M, Olotu A, Beaumont E, Ramos Lopez F, Natama HM, Weston S, Chemba M, Compaore YD, Issiaka D, Salou D, Some AM, Omenda S, Lawrie A, Bejon P, Rao H, Chandramohan D, Roberts R, Bharati S, Stockdale L, Gairola S, Greenwood BM, Ewer KJ, Bradley J, Kulkarni PS, Shaligram U, Hill AVS; R21/Matrix-M Phase 3 Trial Group. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial. Lancet. 2024 Feb 10;403(10426):533-544. doi: 10.1016/S0140-6736(23)02511-4. Epub 2024 Feb 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Matrix-M1 Adjuvant	Other / unclassified	5 ug	—
Subject	Matrix-M1 Adjuvant	Other / unclassified	50 ug	—
Background	Hepatitis A vaccine	Vaccine	—	—
Background	Meningococcal Vaccine	Vaccine	—	—
Background	Rabies vaccine	Vaccine	—	—