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
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.
Lay Summary of Results -
Invasive non-typhoid Salmonella (iNTS) is a serious health threat in sub-Saharan Africa, causing many illnesses and deaths. The Oxford Vaccine Group tested a new vaccine made from outer membrane vesicles (iNTS-GMMA) that targets two common types of this bacteria, S. Enteritidis and S. Typhimurium. The goal of the study was to see how safe and effective the vaccine is.
The SALVO study was conducted in Oxford, UK and involved healthy adults aged 18–55, who were randomly given either the vaccine or a placebo (an inactive substance). The vaccine was given in three doses over six months. A total of 31 participants took part, and 26 of them completed the study.
Results showed that the vaccine was generally safe, with no serious side effects. The most common side effects were mild pain or tenderness in the arm after vaccination. About half of the participants reported mild or moderate side effects within 28 days after receiving the vaccine.
The vaccine was also effective in triggering the immune system. It increased levels of antibodies against the bacteria, and the immune response persisted for up to 1 year after the first vaccination. Further studies of the immune responses to the vaccine are ongoing.
In conclusion, the iNTS-GMMA vaccine was found to be safe and triggered a strong immune response, suggesting it could move forward for further testing in larger trials.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