A Study to Determine if New Types of Malaria Vaccines Are Safe, Effective and Lead to Immunity in Kenyan Adults

Phase 2 Terminated 80 enrolled University of Oxford European and Developing Countries Clinical Trials Partnership (EDCTP) · collab Kenya Medical Research Institute · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase IIb clinical trial in malaria-exposed individuals to assess the immunogenicity, safety and efficacy of the two vaccines in the context of controlled human malaria infection, P. falciparum sporozoite challenge (PfSPZ Challenge).

Timeline

Start: 2022-08-31
Primary completion: 2023-02-26
Completion: 2023-02-26

Publications

Kapulu MC, Orenge F, Kimani D, Kibwana E, Kibet H, Mutahi M, Datoo MS, Bellamy D, Musembi J, Ngoto O, Rashid H, Akinyi S, Mwatasa MH, Nyamako L, Keter K, Gatheru R, Mutiso A, Musyoki J, Mwacharo J, Abebe Y, James ER, Billingsley PF, Ngetsa C, Mosobo M, Makale J, Tawa B, Wamae K, Ochola-Oyier LI, Lawrie A, Ramos-Lopez F, Roberts R, Richie TL, Sim BKL, Hoffman SL, Ewer KJ, Hill AVS, Hamaluba M, Bejon P. Malaria vaccine protection against intradermal or venous parasites: a randomized phase 2b human challenge trial. Nat Med. 2026 Jan;32(1):178-185. doi: 10.1038/s41591-025-04107-6. Epub 2026 Jan 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ChAd63 ME-TRAP	Vaccine	5e+10 unknown	—
Subject	MVA ME-TRAP	Vaccine	2e+08 unknown	—
Subject	Matrix-M1 Adjuvant	Other / unclassified	10 ug	—
Subject	Matrix-M1 Adjuvant	Other / unclassified	50 ug	—

A Study to Determine if New Types of Malaria Vaccines Are Safe, Effective and Lead to Immunity in Kenyan Adults

Summary

Timeline

Publications

Drugs

Indications