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Financement de l’UE (6 871 189 €) : Avancement d’un vaccin à base de GMMA contre la salmonellose invasive non typhoïde dans le cadre d’un essai de phase 1 en Europe et en Afrique subsaharienne Hor14/06/2019 Programme de recherche et d'innovation de l'UE « Horizon »

Texte

Avancement d’un vaccin à base de GMMA contre la salmonellose invasive non typhoïde dans le cadre d’un essai de phase 1 en Europe et en Afrique subsaharienne

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.


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 €

https://cordis.europa.eu/project/id/815439

Cette annonce se réfère à une date antérieure et ne reflète pas nécessairement l’état actuel.