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EU funding (€6,871,189): Advancing a GMMA-based vaccine against invasive non-typhoidal salmonellosis through Phase 1 trial in Europe and sub-Saharan Africa Hor14 Jun 2019 EU Research and Innovation programme "Horizon"
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Advancing a GMMA-based vaccine against invasive non-typhoidal salmonellosis through Phase 1 trial in Europe and sub-Saharan Africa
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.
Funded Companies:
| Company name | Funding amount |
| Fondazione Achille Sclavo Organizzazione NON Lucrativa Di Utilita Sociale | €0.00 |
| Glaxosmithkline Biologicals SA | €0.00 |
| GSK Vaccines Institute FOR Global Health Srl | €1,576,515 |
| Instituut Voor Tropische Geneeskunde | €31,297 |
| Kenya Medical Research Institute | €107,575 |
| Kwame Nkrumah University OF Science AND Technology Kumasi | €194,226 |
| MMGH Consulting GmbH | €20,000 |
| Sclavo Vaccines Association | €1,152,312 |
| The Chancellor, Masters and Scholars of the University of Oxford | €2,227,289 |
| The Chancellor Masters and Scholars of the University of Cambridge | €545,943 |
| The University of Liverpool | €432,035 |
| Universita Degli Studi Di Siena | €341,018 |
| Universite Ouaga I Professeur Joseph KI-Zerbo | €192,980 |
| University OF Malawi | €0.00 |
| University OF Otago | €50,000 |
Source: https://cordis.europa.eu/project/id/815439
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