non-typhoidal Salmonella
Conditions
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written or witnessed/thumb printed informed consent obtained from the participant. Aged between 18 – 45 years In good health as determined by study clinician by: Medical history, Physical examination and heamatology and biochemistry laboratory assessments and Clinical judgement of the investigators Participants satisfying all screening requirements. Participants seronegative for HIV, hepatitis B, and hepatitis C. Females willing to use effective contraception and should be on contraception for at least one month prior to receiving the first vaccine and for the duration of the study. Able to attend the scheduled visits and to comply with all study procedures
Exclusion criteria
Exclusion criteria: History of significant organ/system disease that could interfere with the trial conduct or completion in the clinical judgement of the investigators. Have any known or suspected impairment or alteration of immune function Study significant abnormalities on screening that are either unlikely to resolve or do not resolve on repeat testing Known exposure to non typhoidal Salmonella during lifetime of the subject participant as documented by patient records (e.g., history of microbiologically-confirmed NTS infection) History of any reaction or hypersensitivity likely to be exacerbated by any component of the study. Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination Prior receipt of a typhoid vaccine or the Shigella GMMA vaccine. Plan to receive any vaccine other than the study vaccine within 4 weeks after vaccination. COVID19 vaccines are an exception. Scheduled procedures requiring general anaesthesia during the study Participant who is terminally ill Receipt of immunoglobulin or any blood product transfusion within 3 months of study start Participation in another clinical research study involving an investigational product or a non-investigational intervention (drug or invasive medical device) in the past 12 weeks, or are planning to do so at any point within the trial period Inability, in the opinion of the Investigator, to comply with all study requirements including likelihood of successful venepuncture during the trial Female participants who are pregnant, breastfeeding/lactating or planning pregnancy during the course of the study Weight less than 45kg or a BMI 40 kg/m2 Any other significant disease or disorder which, in the opinion of the Investigator, may: • Put the participants at risk because of participation in the study • Influence the result of the study • Impair the participant’s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and reactogenicity of the iNTS-GMMA vaccine. The following solicited adverse events will be assessed: 1.Tenderness and pain at the injection site 2.Induration at the injection site 3.Redness at the injection site 4.Swelling at the injection site 5.Headache 6.Malaise 7.Myalgia 8.Nausea and/or vomiting 9.Diarrhoea 10.Abdominal Pain 11.Anorexia 12.Fever 13.Arthralgia 14.Fatigue Blood parameters (haematology/biochemistry) Any unsolicited symptom(s) not listed above in addition to any other AE, SAE or SUSAR | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody concentration against S. Typhimurium O antigen and S. Enteritidis O-antigen determined by enzyme linked immunosorbent assay (ELISA) before and 28 days after each dose. Exploratory outcomes include Immunological assays to study the immune responses to vaccines, including but not limited to: 1. Antibody concentration against other potential antigens including porins determined by enzyme linked immunosorbent assay (ELISA) before and after each dose 2. Serum bactericidal antibody (SBA) titre against a panel of vaccine homologous strains before and after each dose 3. Functional antibody analyses which may include opsonophagocytic assays and glycosylation 4. Measurement of antibody persistence 6 months after 3rd dose of vaccine. 5. Quantification of circulating vaccine-induced B-cells responses specific for vaccine antigens before and after each dose 6. Quantification of vaccine-induced, antigen specific T-cell responses and associated cytokine production before and after each dose 7. Gene expression profile after immunization and DNA storage for investigation of the genetic associations with the immune response 8. Faecal antibody concentration against O antigen determined by enzyme linked immunosorbent assay (ELISA) before and after each dose of the vaccine 9 Stool carriage of non-typhoidal Salmonella before and after each dose. | — |
Countries
Kenya
Contacts
Public ContactCommunity Liason Manager
Head Community Liaison group
Outcome results
None listed