A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.

Phase 1/2 Recruiting 480 enrolled University of Oxford European and Developing Countries Clinical Trials Partnership (EDCTP) · collab Institut de Recherche en Sciences de la Sante, Burkina Faso · collab Wellcome Trust · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

This is 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

Timeline

Start: 2023-04-03
Primary completion: 2026-05-30
Completion: 2026-05-30

Outcome

Mixed primary results

paper Comparing the RH5.1/Matrix-M delayed third-dose regimen with the pooled control groups resulted in a vaccine efficacy of 55% (95% CI 20 to 75%; p=0·0071). PMID 39672183 ↗

paper The same analysis showed a vaccine efficacy of 40% (-3 to 65%; p=0·066) when comparing the monthly regimen with the pooled control groups. PMID 39672183 ↗

Publications

Natama HM, Salkeld J, Some A, Soremekun S, Diallo S, Traore O, Rouamba T, Ouedraogo F, Ouedraogo E, Dabone KCS, Kone NA, Compaore ZMJ, Kafando M, Bonko MDA, Konate F, Sorgho H, Nielsen CM, Pipini D, Diouf A, King LDW, Shaligram U, Long CA, Cho JS, Lawrie AM, Skinner K, Roberts R, Miura K, Bradley J, Silk SE, Draper SJ, Tinto H, Minassian AM. Safety and efficacy of the blood-stage malaria vaccine RH5.1/Matrix-M in Burkina Faso: interim results of a double-blind, randomised, controlled, phase 2b trial in children. Lancet Infect Dis. 2025 May;25(5):495-506. doi: 10.1016/S1473-3099(24)00752-7. Epub 2024 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RH5.1	Vaccine	10 ug	Intramuscular
Subject	RH5.2	Unknown	5 ug	—
Background	Matrix-M1 Adjuvant	Other / unclassified	50 ug	Intramuscular