Salmonella Vaccine Study in Oxford (SALVO)
Research type
Research Study
Full title
A Phase 1 Clinical Study to Determine the Safety and Immunogenicity of a Novel GMMA Vaccine Against Invasive Non-Typhoid Salmonella
IRAS ID
1005098
Contact name
Maheshi Ramasamy
Contact email
Sponsor organisation
Research Governance, Ethics and Assurance Team, University of Oxford
Eudract number
2020-000510-14
ISRCTN Number
ISRCTN51750695
Research summary
Nontyphoidal Salmonellae are types of bacteria that can cause gut infections resulting in diarrhoea, both in the UK and globally. However, under some circumstances, these bacteria can cause a more severe illness where infection spreads beyond the gut into the blood stream, a condition termed invasive non-typhoidal Salmonellosis (iNTS). iNTS disease is an under-recognised cause of disease and death in Sub Saharan Africa. In these regions, it primarily occurs in young children, particularly those with malaria and malnutrition. High death rates, difficulties in diagnosing this infection in the developing world, increasing resistance of the bacteria to common antibiotics, and spread via contaminated food and water make development of an effective and affordable vaccine against iNTS an essential control measure.
A new and innovative vaccine (iNTS-GMMA), has been developed which is based on the formation of bacterial outer surface particles. This vaccine facilitates exposure of components of the bacteria to the human immune system without the risk of causing infection. Developed by GSK Biologicals and GSK Vaccines Institute for Global health (GVGH), the aim of this vaccine is to confer immune protection to the most common African strains of the bacteria causing iNTS disease.
This study is a first-in-human clinical trial involving 30-42 healthy adult participants who will be randomly allocated to receive either iNTS-GMMA or a placebo. The main objective of this trial is to evaluate the safety of the iNTS-GMMA vaccine in healthy adults in the UK. The secondary objective is to investigate the human immune response to iNTS-GMMA vaccine. The trial will be participant-observer blind.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0059
Date of REC Opinion
29 Apr 2022
REC opinion
Further Information Favourable Opinion