A Challenge Study to Assess the Blood-stage Efficacy of Full-length SUM-101 Malaria Vaccine Candidate

The goal of the study is to test the efficacy using a homologous CHMI of this vaccine candidate early in the development path in a population living in malaria-endemic areas. In the previous Phase Ia and Ib trials, no efficacy endpoints were defined, and therefore there is currently no data on the SUM-101 vaccine efficacy. The proposed clinical trial will enrol malaria pre-exposed healthy adults and will be the second trial where the IMP will be administered to healthy adult participants in Tanzania with some pre-existing immunity against malaria. The vaccination part of this study will be performed in a randomised, double-blinded, controlled design to evaluate the safety, reactogenicity and immunogenicity of the candidate malaria vaccine SUM-101 (MSP1 with GLA-SE as adjuvant). Given that SUM-101 is a malaria vaccine with an important blood-stage component, we propose to use CHMI with the 3D7 P. falciparum strain-infected red blood cells to establish initial vaccine efficacy data after the third vaccination in a malaria-exposed population.

NCT Number	NCT07124156
Lead Sponsor	European Vaccine Initiative Collaborators: Luxembourg Institute of Health, Ifakara Health Institute
Conditions	Malaria Fever
Enrollment	24 participants
Start Date	2026-03-20
Primary Completion	2026-07-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-21