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The PEDVAC-iNTS project

Invasive non-typhoidal salmonellosis (iNTS), an important overlooked infectious disease in sub- Saharan Africa (sSA), is associated with increasing antibiotic resistance (AMR). Despite an estimated 59,100 iNTS deaths 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.

A novel vaccine, based on the highly cost-effective GMMA-technology, currently being developed by GSK Biologicals and GSK Vaccines Institute for Global Health, includes outer membrane exosomes released by genetically modified Salmonella enterica serovars Typhimurium and Enteritidis, the most common causative agents in sSA. Simple, robust and scalable manufacturing processes for iNTS-GMMA vaccine, suited for sSA, have been developed.

PEDVAC-iNTS primary goal is to advance vaccine development for the use in the target population by conducting a pediatric PhaseI/II study in Ghana. The study builds on the efforts undertaken within Vacc-iNTS EC H2020 funded project, investigating vaccine safety and immunogenicity in healthy European adults. PEDVAC-iNTS evaluates additional vaccine lots using an age and dose escalation approach. Firstly, it will assess safety, in small cohorts of Ghanaian adults, children and infants, and subsequently define the optimal vaccine dose, in a larger infant cohort. Serological and transcriptomic analyses to profile the vaccine immune response are conducted. Additionally, antimicrobial susceptibility of iNTS-causing Salmonella strains, isolated in Ghana, is evaluated.

COORDINATING ORGANISATION:Sclavo Vaccines Association (SVA), Italy
CALL IDENTIFIER:H2020-SC1-2018-Two-Stage-RTD
START DATE:01 March 2021
END DATE:28 February 2025
DURATION:48 months
PARTNERS:7 from 4 countries