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

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

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.
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Coordinator

SCLAVO VACCINES ASSOCIATION

Address

Piazza La Lizza 7
53100 Siena

Italy

Activity type

Research Organisations

EU Contribution

€ 1 152 311,51

Participants (11)

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GSK VACCINES INSTITUTE FOR GLOBAL HEALTH SRL

Italy

EU Contribution

€ 1 576 515

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

United Kingdom

EU Contribution

€ 2 227 288,92

KENYA MEDICAL RESEARCH INSTITUTE

Kenya

EU Contribution

€ 107 575,33

THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE

United Kingdom

EU Contribution

€ 545 942,74

UNIVERSITA DEGLI STUDI DI SIENA

Italy

EU Contribution

€ 341 017,51

PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE

Belgium

EU Contribution

€ 31 296,56

THE UNIVERSITY OF LIVERPOOL

United Kingdom

EU Contribution

€ 432 034,73

UNIVERSITY OF OTAGO

New Zealand

EU Contribution

€ 50 000

UNIVERSITE OUAGA I PROFESSEUR JOSEPH KI-ZERBO

Burkina Faso

EU Contribution

€ 192 980,26

KWAME NKRUMAH UNIVERSITY OF SCIENCE AND TECHNOLOGY KUMASI

Ghana

EU Contribution

€ 194 226,17

MMGH CONSULTING GMBH

Switzerland

EU Contribution

€ 20 000

Project information

Grant agreement ID: 815439

Status

Grant agreement signed

  • Start date

    1 October 2019

  • End date

    30 September 2024

Funded under:

H2020-EU.3.1.3.

Coordinated by:

SCLAVO VACCINES ASSOCIATION

Italy