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.
Written informed consent obtained before any study procedure.
Literate participants aged ≥18 - ≤45 years of African origin.
Female and male participants willing to practice effective contraception from 4 weeks before 1st vaccination (female participants only) and up to 12 weeks after the last vaccination or CHMI (female and male participants)
Female participants must be willing to undergo multiple serum pregnancy tests.
Previous participation in any malaria vaccine trial in the last 3 years.
Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the screening assessment.
Previous history of drug or alcohol abuse interfering with normal social function within one year prior to enrolment.
Previous vaccination with a rabies vaccine.
European Vaccine Initiative
Lead sponsor
Luxembourg Institute of Health
Collaborator
Ifakara Health Institute
Collaborator