Starting on the 1st of March, the PEDVAC-iNTS project aims to advance the clinical development of an urgently needed vaccine against invasive Non-Typhoidal Salmonellosis (iNTS).The European & Developing Countries Clinical Trial Partnership 2 (EDCTP2) funded project will conduct a pediatric Phase I/II study in Ghana, a sub-Saharan Africa country with high medical need. The EDCTP2 programme is supported by the European Union.
Invasive Non-Typhoidal Salmonellosis is an important overlooked poverty-related infectious disease in sub- Saharan Africa (sSA), associated with increasing antibiotic resistance (AMR) and classified by the World Health Organization as a high priority pathogen for developing new antibiotics. Despite an estimated 59,100 iNTS deaths in 2017 and 14.5% case fatality rate particularly in children <5 years of age in sSA, no vaccine is currently available. Medical need, difficult diagnosis and increasing AMR strongly advocate for rapid development of an effective vaccine.
PEDVAC-iNTS is a public-private consortium involving experts from academic institutions, research institutes, small and medium-sized enterprises (SMEs) and non-profit organizations. The PEDVAC-iNTS consortium, made up of 7 institutions from Europe, and Ghana, aims at advancing the development of an urgently needed iNTS vaccine by conducting this pediatric Phase I/II study in Ghana.
The PEDVAC-iNTS project will advance the clinical development of the iNTS-GMMA vaccine, based on the highly cost-effective GMMA-technology developed by GlaxoSmithKline Biologicals SA (GSK) and GSK Vaccines Institute for Global Health and includes outer membrane exosomes released by genetically modified Salmonella enterica strains belonging to the most common serovars that cause iNTS in Africa. PEDVAC-iNTS will use an age de-escalation and dose escalation approach by: first assessing safety, in small cohorts of Ghanaian adults, children and infants, and subsequently defining the optimal vaccine dose for further development, in a larger number of infants. Serological and transcriptomic analyses will be also conducted to further profile the vaccine immune response. Additionally, antimicrobial susceptibility of iNTS-causing Salmonella strains, isolated in Ghana, will be evaluated to enhance the database of AMR pathogens in sSA.
In addition to the clinical development goal, the PEDVAC-iNTS project will strengthen a collaborative network of experts, including partners from African countries, to also enhance disease awareness in resource-limited endemic countries where iNTS is causing a significant public health burden. The PEDVAC-iNTS network also aims to work with global and regional policy and decision makers to establish the necessary preconditions for successful iNTS vaccine implementation in sSA.
“The PEDVAC-iNTS project is a unique collaborative effort to further advance the clinical study of much-needed iNTS-GMMA vaccine by conducting a pediatric Phase I/II study in Ghana, a sub-Saharan Africa country with high medical need. The PEDVAC-iNTS consortium will generate data to accelerate vaccine development and enhance disease awareness in resource- limited endemic countries where iNTS disease is causing a significant public health burden. Thought this collaboration/With the PEDVAC-iNTS studies, we have high hopes to advance the development of a successful iNTS vaccine that meets the necessary preconditions for successful implementation in endemic countries as early as possible” says Prof. Donata Medaglini, project coordinator.
The PEDVAC-iNTS project represents an important step forward in the development of a vaccine against a pathogen with alarming antibiotic resistance and in the fight against a poverty-related disease that is claiming a very large number of childhoods lives in Sub-Saharan Africa and that has a huge health and socioeconomic impact in resources-poor countries.
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)