Study to evaluate the immune responses against Salmonella Typhi after vaccination with Vivotif®
- Conditions
- Typhoid fever caused by Salmonella TyphiInfections and Infestations
- Registration Number
- ISRCTN18360696
- Lead Sponsor
- Kantonsspital St.Gallen Hospital
- Brief Summary
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28570603 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1. Ability to understand the experimental nature of the vaccine evaluation and the participant informed consent form
2. Written informed consent documented by date and signature to be obtained prior to any study specific procedure
3. Age 18-50 years old
4. Regular bowel movement (1+ defecation per day)
5. Willingness to adhere to the strict timing schedule for the study evaluation
6. Willingness to provide stool and blood samples in the indicated visits
1. Previous use of an oral vaccine against Salmonella in the past three years
2. Gastrointestinal infection caused by any Salmonella species during the past 3 years
3. Positive HIV serology or any known immune deficiency
4. Current or planned pregnancy during the course of the study
5. Unwillingness to use at least one method of birth control in women of childbearing age during the course of the study
6. Are breastfeeding
7. Suffer from obstipation
8. Suffer from hypersensitivity to any component of the vaccine or the enteric-coated capsule
9. Use of an immune modulator in the past year
10. Use of systemic corticosteroid treatment in the past 30 days
11. Use of antibiotics within 1 week preceding and during the present study
12. Current use of proton-pump inhibitors
13. Participation in another study with investigational drug within the 30 days preceding and during the present study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method