at a glance
01 October 2019 to 31 December 2025
European Vaccine Initiative
8.6 Mio Euro
Early clinical development of an oral Shigella vaccine through phase II study in Africa
The ShigaPlexIM project aims at advancing the early clinical development of an injectable Shigella vaccine through Phase I and descending age studies with and without an adjuvant in Africa. We will test a safe and highly immunogenic Shigella vaccine, InvaplexAR-Detoxthat has already completed a successful Phase 1 trial in U.S adults without adjuvant where it demonstrated excellent safety and immunogenicity. The current formulation should provide coverage for Shigella flexneri serotypes 2a, 3a and 6. Shigella sonnei LPS will be added at a later stage of development of this product to optimise serotype coverage in future field efficacy trials.
Specific objectives of this project include (i) conduct of a phase Ia/Ib clinical trial in European and African adults with the vaccine administered with or without the mucosal adjuvant, double mutant labile toxin (dmLT) followed by (ii) an age de-escalating phase II in Burkina Faso.
Moreover, specific epidemiologic data will be generated on the incidence of Shigella disease in Burkina Faso and Zambia among children under five presenting with moderate to severe diarrhoea at primary healthcare facilities. The results of this project will strengthen the vaccine pipeline against a major diarrhoeal disease and making it available for late stage clinical development.
Centre for Infectious Disease Research in Zambia (Zambia); European Vaccine Initiative (EVI) (Germany); Groupe de Recherche Action en Santé (GRAS) (Burkina Faso); Leiden University Medical Center (LUMC) (Netherlands); PATH (FATH, Switzerland); University of Gothenburg (Sweden).
This project is part of the EDCTP2 Programme supported by the European Union (RIA2018V-2308). The views and opinions of authors expressed herein do not necessarily state or reflect those of EDCTP.