Projektbeschreibung
Veränderte Bakterien produzieren Impfstoff gegen invasive nicht-typhöse Salmonellose
Die invasive nichttyphoidale Salmonellose (iNTS) wird immer stärker zum Problem für die öffentliche Gesundheit, insbesondere in Afrika südlich der Sahara, wo die Anzahl der Todesfälle noch größer ist als die durch Typhus. Üblicherweise sind Säuglinge, Kleinkinder und immungeschwächte Erwachsene betroffen. 20bis 25 % der Fälle verlaufen tödlich. Impfstoffe werden hier dringend benötigt. Das EU-finanzierte Projekt Vacc-iNTS hat eine neue Herstellungsmethode für Impfstoffe entwickelt, die einfach und kostengünstig ist und einen Wirkstoff ergibt, der sehr gut Immunreaktionen im Körper auslösen kann. Klinische Studien der Phase 1 stehen kurz bevor und es gibt bereits Pläne für Datensammlungen, um die Durchführung von Phase 2 und 3 zu unterfüttern.
Ziel
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.
Wissenschaftliches Gebiet
- 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
Schlüsselbegriffe
Programm/Programme
Thema/Themen
Aufforderung zur Vorschlagseinreichung
Andere Projekte für diesen Aufruf anzeigenUnterauftrag
H2020-SC1-2018-Two-Stage-RTD
Finanzierungsplan
RIA - Research and Innovation actionKoordinator
53100 Siena
Italien