Vacc-iNTS SIGNED
Advancing a GMMA-based vaccine against invasive non-typhoidal salmonellosis through Phase 1 trial in Europe and sub-Saharan Africa
Total Cost €
0EC-Contrib. €
0Partnership
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Explore the words cloud of the Vacc-iNTS project. It provides you a very rough idea of what is the project "Vacc-iNTS" about.
Project "Vacc-iNTS" data sheet
The following table provides information about the project.
| Coordinator |
SCLAVO VACCINES ASSOCIATION
Organization address contact info |
| Coordinator Country | Italy [IT] |
| Total cost | 0 € |
| EC max contribution | 6˙871˙188 € (0%) |
| Programme |
1. H2020-EU.3.1.3. (Treating and managing disease) |
| Code Call | H2020-SC1-2018-Two-Stage-RTD |
| Funding Scheme | RIA-LS |
| Starting year | 2019 |
| Duration (year-month-day) | from 2019-10-01 to 2024-09-30 |
Partnership
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Project objective
Invasive non-typhoidal Salmonellosis (iNTS) is an important emerging Neglected Infectious Disease in resource-poor settings of sub-Saharan Africa (sSA). No vaccine is currently available. Estimated 263,000 iNTS deaths per year in <5 year olds, a 20% case fatality rate, difficult diagnosis and increasing antibiotic resistance strongly advocate for rapid development of an effective vaccine. Vacc-iNTS bridges the gap between preclinical and early clinical development of a novel vaccine against iNTS, based on GMMA (Generalized Modules for Membrane Antigens) from the most common African iNTS serotypes (Typhimurium and Enteritidis). The highly cost-effective GMMA-technology, developed by partner 2, is based on outer membrane blebs released by genetically modified bacteria. Clinical proof-of-concept for the GMMA-technology was achieved with a Shigella sonnei vaccine in European and African adults. In animals, iNTS-GMMA were highly immunogenic and induced antibodies with bactericidal activity against African iNTS strains. Simple, robust and scalable manufacturing processes for iNTS-GMMA, suited for sSA, have been developed. Vacc-iNTS proposes GMP manufacturing of clinical lots followed by a two-stage Phase 1 trial in healthy European and African adults to investigate safety and immunogenicity of the iNTS-GMMA vaccine. Analysis include serum antibody levels and functionality, cellular responses, transcriptomics and data integration through a systems biology approach. Sero-epidemiological analysis will be conducted to provide essential data for future Phase 2 and 3 trials. Vacc-iNTS will also strengthen a collaborative network of iNTS experts from academia, industry and non-profit including partners from disease-endemic countries of sSA. The network will generate data to accelerate further vaccine development, enhance awareness, drive advocacy and vaccine deployment in limited-resources disease-endemic countries, tackling major roadblocks in advancing a vaccine against iNTS.
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