The overall aim of PEDVAC-iNTS is to conduct a pediatric Phase I/II age de-escalation dose finding clinical study in sub-Saharan Africa (sSA) to advance the development of a novel vaccine (iNTS-GMMA) against invasive non-typhoidal Salmonella, a WHO antibiotic-resistant priority pathogen. This effort will significantly contribute towards national and international plans for containment of antimicrobial-resistant Salmonella spread.
The PEDVAC-iNTS overall strategy, schematically illustrated below, envisages GMP manufacture of the iNTS-GMMA vaccine; conduct in Ghana a Phase I/II age-de-escalation study in adults, children and infants, including dose-finding in infants; and evaluation of safety, reactogenicity, and immunogenicity of the iNTS- GMMA vaccine. In parallel, the antimicrobial susceptibility patterns and AMR genetic markers of iNTS strains in Ghanaian patients will be analyzed contributing to integrate information about antimicrobial resistance in sSA.
Specific objectives of the project include:
- Technology transfer, GMP manufacture and release of vaccine and placebo lots
- Pediatric Phase I/II age de-escalation dose finding study to demonstrate safety and immunogenicity of iNTS-GMMA in Ghana
- In depth analysis of immunological and molecular signatures elicited by iNTS-GMMA
- Study of AMR burden of iNTS in Ghana to describe the circulating Salmonella serogroups and associated antibiotic resistance
- Planning and starting effective collaboration with public authorities and international organisations to aid in vaccine progression towards licensure and implementation as an effective tool to contain AMR improving public health in LMIC
- Enhance awareness of iNTS disease and AMR burden through a collaborative network of experts from academia, industry and non-profit organizations including partners from sSA countries