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Project description

The overall objective of the Vacc-iNTS project is to advance the development of a candidate vaccine against the invasive non-typhoidal Salmonellosis (iNTS), an emerging bacterial neglected infectious disease of sub-Saharan Africa (sSA). Vacc-iNTS aims at conducting a Phase I clinical trial to demonstrate the safety and immunogenicity of the iNTS-GMMA candidate vaccine in healthy European and African adults and performing preparatory activities for effective vaccine uptake in limited-resource endemic countries. The iNTS-GMMA vaccine is based on the GMMA technology and consists of highly immunogenic bacterial outer membrane exosomes from the most common African Salmonella enterica serovars Typhimurium and Enteritidis. A comprehensive set of pre-clinical data supports the clinical development of the iNTS-GMMA candidate vaccine. The simple, robust and scalable manufacturing process, and thermal stability of the GMMA technology make the iNTS-GMMA vaccine affordable to manufacture and deliver to limited-resource settings. Furthermore, the clinical proof-of-concept for the GMMA technology was achieved with the Shigella sonnei GMMA vaccine tested in European and African adults.   

The major ambition of the Vacc-iNTS project is to bridge the gap between preclinical and early clinical development of a highly promising iNTS vaccine candidate by conducting a two staged Phase I clinical trial and sero-epidemiology studies. Moreover, this project aims at generating the evidence on iNTS disease burden, vaccine demand and public health impact to plan an effective deployment and uptake of the iNTS-GMMA vaccine by endemic countries.

The Vacc-iNTS project builds on a unique and well-placed group of experts with extensive experience in poverty-related diseases including iNTS, clinical trials, vaccine development and public health knowledge, and promotes an intervention against a neglected infectious disease that may not be developed through normal market forces.

Vacc-iNTS specific objectives

  • Manufacturing of the clinical batches of the placebo and iNTS-GMMA vaccine
  • Conduction of a two staged Phase I study to demonstrate safety and immunogenicity of the iNTS-GMMA vaccine in healthy European and African adults
  • In depth analysis of the immunological and molecular signatures elicited by the iNTS-GMMA vaccine in samples obtained from the clinical trial conducted in Europe and Africa
  • Sero-epidemiology studies in high-burden African sites to plan for and select sites for future Phase II and III studies on the iNTS-GMMA vaccine
  • Epidemiological analysis and modelling of iNTS transmission for an accurate estimate of disease burden
  • Planning and evaluation of effective deployment and uptake of the iNTS-GMMA vaccine in low-resource public health systems through the collation of burden, cost of illness, and other epidemiological data to support and pursue a cost-effectiveness analysis for vaccine introduction in endemic countries
  • Training of physicians and laboratory staff from iNTS endemic countries to build capacity and foster specialized knowledge in limited-resource countries
  • Strengthen a multidisciplinary collaborative network of iNTS experts from academia and industry, including disease-endemic sSA countries, to delineate a clear pathway for vaccine uptake by health systems in limited-resource settings