Project: Early clinical development of an oral Shigella vaccine through phase II study in Africa

Acronym ShigOraVax (Reference Number: RIA2018V-2308)
Duration 01/10/2019 - 30/09/2024
Project Topic Shigella is one of the leading causes of diarrhoeal deaths in age groups and is reported as the second most common cause of diarrhoeal deaths in children under 5 years of age, after rotavirus. Still there is no vaccine available for use against Shigella. Additionally, there is paucity of accurate data on the actual burden of disease in the regions most affected. This multidisciplinary, international consortium has assembled to develop a safe, efficacious and affordable Shigella vaccine. This vaccine has been designed to ensure maximum uptake in the low resource setting. Since immunity to Shigella appears to be strain-specific, we will develop a tetravalent whole cell inactivated oral Shigella vaccine ‘ShigOraVax’, containing Shigella flexneri serotypes 2a, 3a, and 6, as well as Shigella sonnei. This vaccine candidate is expected to cover the commonly isolated pathogenic strains of Shigella. The vaccine can be administered orally, has a low cost and is easy to manufacture. Through this project, we intend to develop the proposed Shigella vaccine candidate up to mid clinical stage. Specific objectives of this project include (i) conduct of a phase Ia/b clinical trial in European and African adults followed by (ii) an age de-escalating phase II in Burkina Faso and a multi-centre phase IIb clinical trial in Burkina Faso and Zambia. Moreover, specific epidemiologic data will be generated on the incidence of shigella disease in the two African countries among children under 5 presenting with moderate to severe diarrhoea at primary health care facilities. Partners in our consortium are highly skilled and come from Africa, Europe, and India. The Consortium includes the European Vaccine Initiative (Germany); MSD-Wellcome Trust Hilleman Laboratories (India); Leiden University Medical Centre (Netherlands); Gothenburg University (Sweden); Groupe de Recherche Action en Santé (Burkina Faso); and Centre for Infectious Disease Research in Zambia. Successful completion of this project will strengthen the vaccine pipeline against a major diarrhoeal disease and making it available for late stage clinical development and eventual deployment in the low resource setting, and will in this process strengthen human capacity for vaccine clinical research and development in Burkina Faso and Zambia.
Network EDCTP2
Call Vaccines for diarrhoeal diseases or lower respiratory tract infections

Project partner

Number Name Role Country
1 European Vaccine Initiative Coordinator Germany
5 Centre for Infectious Disease Research in Zambia Limited Partner Zambia
7 Groupe de Recherche Action en Santé sarl. Partner Burkina Faso
9 MSD Wellcome Trust Hilleman Laboratories Partner India
10 University of Gothenburg Partner Sweden