Note paper of the Vacc-iNTS project

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

The international project Vacc-iNTS, coordinated by Sclavo Vaccine Association and funded for 5 years by the European Commission, aims to advance development of the vaccine by conducting a Phase 1 clinical study of adults in Europe and Africa.

Invasive non-typhoidal salmonellosis is an emerging neglected infectious disease of sub-Saharan Africa that mainly affects children (under 5 years old) and immunocompromised individuals. In 2017, it was estimated to be responsible for about 31,600 deaths among children with a case-fatality rate of about 14%. Its difficult diagnosis and increasing antibiotic resistance strongly advocate for rapid development of an effective vaccine that is currently not available.

The Vacc-iNTS consortium, made up of 12 partners from 8 different countries aims to advance the development of an urgently needed iNTS vaccine by conducting a Phase I clinical study in adults of Europe and Africa. Vacc-iNTS consortium includes 4 iNTS disease-endemic countries:  Burkina Faso, Ghana, Kenya and Malawi. Vacc-iNTS will investigate the immunogenicity and safety of the iNTS-GMMA vaccine, a novel vaccine based on outer membrane blebs released by genetically modified bacteria, developed by the GSK Vaccine Institute for Global Health (GVGH) using the GSK-owned outer membrane (GMMA) technology. This technology is characterized by a simple, robust and scalable manufacturing process that makes it a suitable platform for the development of vaccines against poverty-related diseases. Exploratory immunological analyses and sero-epidemiology studies will also be performed to support further vaccine development. Vacc-iNTS will strengthen a collaborative network to enhance disease awareness and drive advocacy.

The Vacc-iNTS project represents an important step towards developing a vaccine to counter a poverty-related disease negatively impacting the health and economies of resource-poor countries. The 5-year project has a total budget of € 6.8 MM and is funded by the European Union’s Horizon 2020 Research and Innovation Programme.

Facts about Vacc-iNTS:

    • Title: Advancing a GMMA-based vaccine against invasive non-typhoidal salmonellosis through Phase 1 trial in Europe and sub-Saharan Africa Acronym: Vacc-iNTS
    • Start Date: 01 October 2019 – End Date: 30 September 2024
    • Coordinator: Sclavo Vaccines Association (Italy)
    • EU funding: 6.8 MM EUR
    • Project funder: This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 815439

The Vacc-iNTS network of experts from academic, industry and non-profit organizations.

Participants:

    • Sclavo Vaccines Association (Italy)
      • Fondazione Achille Sclavo ONLUS (Italy)
    • GSK Vaccines Institute for Global Health (Italy)
      • GSK Biologicals (Belgium)
    • University of Oxford (United Kingdom)
    • Kenya Medical Research Institute (Kenya)
    • University of Cambridge (United Kingdom)
    • University of Siena (Italy)
    • Institute of Tropical Medicine Antwerp (Belgium)
    • University of Liverpool (United Kingdom)
      • University of Malawi (Malawi)
    • University of Otago (New Zealand)
    • Université Ouaga I Professeur Joseph Ki-Zerbo (Burkina Faso)
    • Kwame Nkrumah University of Science and Technology Kumasi (Ghana)
    • MMGH Consulting GMBH (Switzerland)

Fondazione Achille Sclavo is heading activities aimed at increasing knowledge and awareness of iNTS disease burden in Sub-Saharan Africa. Moreover, Fondazione Achille Sclavo is responsible for the preparation of a dossier on iNTS disease providing its neglected status to be presented to WHO.

Vacc-iNTS project is also supported by the outcomes coming from the S-AFRIVAC project carried out within the health research grant from the Tuscany Regional government and managed by Fondazione Achille Sclavo in 2016-2018 years.

For more information please see:

  • the flyer of the project here
  • the Vacc-iNTS project website here