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Advancing a GMMA-based vaccine against invasive non-typhoidal salmonellosis through Phase 1 trial in Europe and sub-Saharan Africa

Project description

Bacteria engineered to produce vaccines for invasive non-typhoidal salmonellosis

Invasive non-typhoidal Salmonella (iNTS) disease is a major emerging public health concern, particularly in sub-Saharan Africa, where cases of fatality greatly exceed those due to typhoid fever. Commonly affecting infants, young children, and immuno-compromised adults, morbidity occurs in 20-25 % of cases. Vaccines are desperately needed here. The EU-funded Vacc-iNTS project has used a new methodology for vaccine production that is simple, low-cost and very effective at inducing an immune response in the body. They are going to test it in Phase 1 clinical trials and are already planning data collection to support Phase 2 and 3 activities.

Objective

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.

Call for proposal

H2020-SC1-BHC-2018-2020

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Sub call

H2020-SC1-2018-Two-Stage-RTD

Coordinator

SCLAVO VACCINES ASSOCIATION
Net EU contribution
€ 837 070,56
Address
PIAZZA LA LIZZA 7
53100 Siena
Italy

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Region
Centro (IT) Toscana Siena
Activity type
Research Organisations
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Total cost
No data

Participants (14)