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Invasive non-typhoidal salmonellosis (iNTS) is an emerging bacterial neglected infectious disease that mainly affects children under 5 years of age and immunocompromised subjects. In 2017, iNTS was estimated to cause 59.100 deaths globally with an average case fatality rate of 14.5% (Lancet Infect Dis 2018-2019). The majority of cases are observed in sub-Saharan Africa, where iNTS is among the leading cause of community-acquired bloodstream infections. Salmonella enterica serovars Typhimurium and Enteritidis are the most commonly associated with invasive disease, causing 90% of cases (PLoS NTD 2017). There is no licensed vaccine against iNTS, and the emergence of antimicrobial-resistant strains is compromising efficacy of current affordable antimicrobials. High case fatality rates, difficult diagnosis and increasing antibiotic resistance strongly advocate for rapid development of an effective vaccine.

The aim of the Vacc-iNTS research project on “Advancing a GMMA-based vaccine against invasive non-typhoidal salmonellosis through Phase 1 trial in Europe and sub-Saharan Africa” is to advance the development of the iNTS-GMMA candidate vaccine against the invasive non-typhoidal salmonellosis (iNTS).

iNTS is an emerging bacterial neglected infectious disease responsible for a huge health and socioeconomic impact in sub-Saharan Africa. The Vacc-iNTS research project aims at bridging the gap between preclinical and early clinical development of a novel vaccine against iNTS. The iNTS-GMMA vaccine, based on the cost-effective GMMA technology, is composed of highly immunogenic outer membrane blebs used as antigen delivery system from the two most common African iNTS serotypes (Typhimurium and Enteritidis).

The objective of the Vacc-iNTS project is to conduct a Phase I study to demonstrate the safety and immunogenicity of the iNTS-GMMA candidate vaccine in healthy European and African adults, and to strengthen a collaborative network of iNTS experts to raise awareness of disease burden and favor vaccine deployment in limited-resource settings.

Vacc-iNTS is a consortium of 12 partners from 8 different countries, including iNTS-endemic countries, that involves experts from academic and research institutions. The project has a duration of 5 years and is funded by the European Commission for a total budget of 6 871 188.73 €.

COORDINATOR: Sclavo Vaccines Association
CALL IDENTIFIER: H2020-SC1-2018-Two-Stage-RTD
START DATE: 01 October 2019
DURATION: 60 months
PARTNERS: 12 from 8 countries