Salmonella Vaccine Immunogenicity and Safety (SaVIS) Study
- Conditions
- non-typhoidal Salmonella
- Registration Number
- PACTR202310834458532
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
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
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 < 18.4 kg/m2 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method