Descripción del proyecto
Se diseñan bacterias para producir vacunas contra la salmonelosis no tifoidea invasiva
La salmonelosis no tifoidea invasiva (iNTS, por sus siglas en inglés) es una nueva preocupación importante para la salud pública, especialmente en el África subsahariana, donde los casos de muerte superan considerablemente a los de la fiebre tifoidea. Esta enfermedad, que habitualmente afecta a bebés, niños y adultos con deficiencias inmunitarias, presenta morbilidad en el 20-25 % de los casos, por lo que se necesitan urgentemente vacunas. El proyecto financiado con fondos europeos Vacc-iNTS ha empleado una nueva metodología para la producción de vacunas que es simple, de bajo coste y muy eficaz al inducir una respuesta inmune en el cuerpo. Se va a probar en ensayos clínicos de fase 1 y ya se está planificando la recopilación de datos para respaldar las actividades de las fases 2 y 3.
Objetivo
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.
Ámbito científico
- 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
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SC1-2018-Two-Stage-RTD
Régimen de financiación
RIA - Research and Innovation actionCoordinador
53100 Siena
Italia