The Vacc-iNTS project for the manufacture and clinical development of a vaccine against invasive non-typhoidal salmonellosis (iNTS) disease funded by the European Commission has started.
Invasive non-typhoidal salmonellosis is an emerging neglected infectious disease of sub-Saharan Africa that mainly affects children under 5 years of age and immunocompromised subjects. In 2017, iNTS was estimated to be responsible for about 31,600 deaths among children younger than 5 years, with a case-fatality rate of about 14%. The 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 including 3 iNTS disease- endemic 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 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. The 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 network of experts from academic, industry and non-profit organizations met in Siena on the 24-25th October 2019 for the project kick-off meeting. The 5-year project has a total budget of € 6.8 MM and it is funded by the European Union’s Horizon 2020 Research and Innovation Programme.
Dr. Rino Rappuoli, vaccinologist, Scientific Coordinator of the Project and Chief Scientist and Head External R&D at GSK stated: “This project is an important step in the fight against a neglected disease that is claiming a very large number of lives of children living in Sub-Saharan Africa. The development of this vaccine against a pathogen with alarming antibiotic resistance, is a success of the joint efforts of industry, public and not-for-profit sectors”.
Donata Medaglini, Professor at the University of Siena and Project Coordinator commented: “The project Vacc-iNTS is an unprecedented effort to test this new vaccine that for the first time tackles the problem of protecting populations against invasive non-typhoidal salmonellosis. Thanks to the collaboration between industry and leading research institutions in Europe, New Zealand, Kenya, Burkina Faso, Malawi and Ghana, our hope is to make this vaccine against this deadly disease available in endemic countries as early as possible”.
“The Vacc-iNTS network will generate data to accelerate further vaccine development and tackle major roadblocks in advancing an effective deployment and uptake by limited-resources public health systems of a sustainable iNTS vaccine; MMGH will contribute to the project by helping designing an effective and broad-reaching advocacy and knowledge-transfer strategy” says Stefano Malvolti, Managing Director and co-founder of MMGH Consulting. “The successful experience of the Hib-initiative and Pneumo and Rota ADIPs, that saw several of us involved in different capacities, offer a wealth of lessons learnt and transferrable practices that can greatly contribute to the acceleration of the iNTS project implementation”.
The Vacc-iNTS project represents an important step forward in the development of a vaccine to counter a poverty-related disease responsible for a huge health and socioeconomic impact in resource-poor countries.
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
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
- Sclavo Vaccines Association (Italy)
- Fondazione Achille Sclavo ONLUS
- GSK Vaccines Institute for Global Health (Italy)
- GSK Biologicals
- 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
- 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)