Descrizione del progetto
Batteri ingegnerizzati per produrre vaccini per la salmonellosi invasiva non tifoidea
La salmonella invasiva non tifoidea (iNTS, invasive Non-Typhoidal Salmonella) è una delle principali preoccupazioni emergenti per la salute pubblica, in particolare nell’Africa sub-sahariana, dove i casi di mortalità superano di molto quelli dovuti alla febbre tifoide. Colpendo comunemente neonati, bambini piccoli e adulti immuno-compromessi, la morbilità si verifica nel 20-25 % dei casi. I vaccini risultano pertanto essere disperatamente necessari. Per la produzione di vaccini, il progetto Vacc-iNTS, finanziato dall’UE, ha utilizzato una nuova metodologia semplice, economica e molto efficace per indurre una risposta immunitaria nel corpo. Questa sarà testata in sperimentazioni cliniche di Fase 1, mentre è già in programma la raccolta di dati per supportare le attività di Fase 2 e 3.
Obiettivo
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.
Campo scientifico
- engineering and technologymechanical engineeringmanufacturing engineering
- natural sciencesbiological sciencesmicrobiologybacteriology
- medical and health scienceshealth sciencesinfectious diseases
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines
- medical and health sciencesbasic medicinepharmacology and pharmacydrug resistanceantibiotic resistance
Parole chiave
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SC1-2018-Two-Stage-RTD
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
53100 Siena
Italia