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PEDVAC-iNTS starts a Phase 2 clinical trial of a vaccine against invasive Non-Typhoidal Salmonellosis, iNTS-GMMA, in Ghana.

The PEDVAC-iNTS Consortium announced today that the first participant has been vaccinated with the iNTS- GMMA vaccine in a Phase 2 study in Ghana. The iNTS-GMMA vaccine is a candidate vaccine against invasive Non-Typhoidal Salmonellosis (iNTS), a major cause of death and disability in sub-Saharan Africa. There are currently no licensed vaccines against the disease.

The first participant received the iNTS-GMMA vaccine on Friday 09 February 2024, marking a milestone in the development of this innovative vaccine. The trial will assess the safety, reactogenicity, and immune response to the iNTS-GMMA candidate vaccine in adults, children, and infants.   It is sponsored by GSK, the global biopharma company, and the study site is Agogo in the Asante Akim North District of Ghana with Prof Ellis Owusu-Dabo from Kwame Nkrumah University of Science and Technology (KNUST), Ghana as the Principal Investigator.

Invasive Non-Typhoidal Salmonellosis is an often-overlooked infectious disease which predominantly impacts people living in sub-Saharan Africa. It is associated with increasing antimicrobial resistance (AMR), meaning the bacteria which cause it are developing resistance to the antibiotics currently used to treat the disease, and it is classified by the World Health Organization as a high priority pathogen for developing new antibiotics. As a result, preventing the disease is becoming increasingly important. Despite an estimated 48,000 iNTS deaths and 15% case fatality rate in children <5 years of age in sub-Saharan Africa, no vaccine is currently available to prevent iNTS. High medical need, difficult diagnosis and increasing AMR strongly advocate for rapid development of an effective vaccine.

The vaccine is based on the Generalized Modules for Membrane Antigens (GMMA) technology, developed by GSK, which involves a relatively simple and scalable manufacturing process. iNTS-GMMA uses outer membrane vesicles released by genetically modified Salmonella Typhimurium and Enteritidis, the most common serotypes causing iNTS in Africa.

Donata Medaglini, Vice Rector of the University of Siena and Project Coordinator, said  ”We are excited to announce the commencement of the PEDVAC-iNTS clinical study. Building upon the successes of the Vacc-iNTS project, which conducted a Phase I trial of the iNTS-GMMA vaccine in healthy European adults, the PEDVAC-iNTS consortium, comprised of 7 institutions from Europe and Ghana, is dedicated to advancing the development of this critically needed iNTS vaccine. The initiation of this Phase 2 pediatric study in Ghana marks a significant milestone for PEDVAC-iNTS, poised to generate invaluable data and insights crucial to advancing the development of the iNTS-GMMA vaccine and its eventual implementation in Africa.”  

Francesco Berlanda Scorza, Head of Global Health Vaccines R&D at GSK, said “This is an exciting moment in the development of a much needed candidate vaccine against iNTS. At GSK, we’re proud that our innovative GMMA technology has potential to help tackle this disease which, despite causing tens of thousands of deaths every year in some of the most vulnerable populations, is not yet vaccine preventable.”

Ellis Owusu-Dabo, Pro Vice-Chancellor and Professor of Epidemiology and Global Health at Kwame Nkrumah University of Science and Technology, said “it is indeed a delight to witness this day that offers hope for the population of iNTS sufferers who are mainly infants and children within our communities.”

The trial is being conducted as part of the PEDVAC- iNTS project (www.pedvac-ints.eu), which aims to advance the clinical development of an urgently needed vaccine against invasive Non-Typhoidal Salmonellosis (iNTS) under the coordination of the Sclavo Vaccines Association. The PEDVAC-iNTS project is funded by the European & Developing Countries Clinical Trial Partnership 2 (EDCTP2). The EDCTP2 programme is supported by the European Union.

Facts about PEDVAC-iNTS:

Title: Pediatric Phase I/II age de-escalation dose finding study of a vaccine against invasive non-typhoidal salmonellosis in sub-Saharan Africa

Acronym: PEDVAC-iNTS

Duration and start date: 48 months from 1st March 2021

Coordinator: Sclavo Vaccines Association (Italy)

EDCTP contribution: 5,698,963.75 EUR

Project funder: This project is part of the EDCTP2 programme supported by the European Union (Grant Agreement number: RIA2019AMR-2658 PEDVAC-iNTS RIA2019AMR)

Participants:

  • Sclavo Vaccines Association (Italy)
  • GSK Vaccines Institute for Global Health (Italy)
  • Kwame Nkrumah University of Science and Technology Kumasi (Ghana)
  • Bernhard-Nocht-Institut für Tropenmedizin (Germany)
  • Università di Siena (Italy)
  • MMGH Consulting GMBH (Switzerland)
  • VisMederi (Italy)