iNOVVEL

The Invasive Non-Typhoidal Salmonella (iNTS) Vaccine Value Evaluation and Development (iNOVVEL) was established as a joint project by the International Vaccine Institute and WHO/Vaccine Product & Delivery Research Immunization, Vaccines and Biologicals in 2021 through funding support from the Wellcome Trust. From 2021–2025, it worked to develop a Full Value of Vaccine Assessment to ensure that safe, effective, and affordable iNTS vaccines were available and implemented to decrease the burden of iNTS disease in those most in need.

Age-standardized DALY rates (per 100,000) by location, both sexes combined, 2021
Source: Institute for Health Metrics and Evaluation (IHME). GBD 2021 Cause and Risk Summary: Invasive Non-typhoidal Salmonella (iNTS). Seattle, USA: University of Washington, 2024
  • Estimated to cause over 500,000 cases of invasive disease
  • Leading to more than 79,000 deaths with a high case fatality ratio (14.5%)
  • Affecting mostly infants and young children in low- and middle-income countries in sub-Saharan Africa
  • Exhibits increasing levels of antibiotic resistance

While there are no iNTS vaccines available for use in humans, there are several potential candidate vaccines under development. These vaccine development pathways include a bivalent iNTS vaccine (Salmonella Typhimurium and Salmonella Enteritidis) and a trivalent vaccine (Salmonella typhi combined with iNTS).

Full Value of Vaccine Assessment for invasive Non-Typhoidal Salmonella Vaccines (2021–2025)

The objectives of iNOVVEL included the development of a vaccine research and development roadmap, Preferred Product Characteristics, the definition of the Regulatory Pathway, and provision of the rationale for investment in development and deployment of the vaccine through a Full Value of Vaccine Assessment.

Under the joint leadership through a consensus process, IVI and WHO worked together to develop WHO Preferred Product Characteristics for iNTS vaccines and R&D roadmap for iNTS vaccines following a series of consultation process (WHO Nontyphoidal Salmonella page, Report of a WHO expert consultation) as well as determining the Clinical Development Plan and Regulatory Pathway to bring iNTS vaccines to licensure and WHO prequalification.

Overview of timeline of development of Preferred Product Characteristics and research and development roadmap for iNTS vaccines

Full Value of Vaccine Assessment

IVI in collaboration with other partners (Shift Health, London School of Hygiene and Tropical Medicine, Swiss Tropical and Public Health Institute, and New York University) led the development of a Full Value of Vaccine Assessment to understand the value of investment in an iNTS vaccine and to develop a rationale for the development of a vaccine for iNTS from a multi-stakeholder perspective encompassing the business case, investment case, and broader societal benefits of vaccines.

Meeting reports and publications