Typhoid fever caused by Salmonella Typhi Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Antibody levels of IgM and IgG specific against porins in serum (during visits 2, 5, 6 and 7) and IgA in stool (during visits 2, 5, 6 and 7) via enzyme-linked immunosorbent assay (ELISA) 2. Number of porins-specific T cells from blood (during visits 2, 5, 6 and 7) via flow cytometry 3. Amount of porins-specific B cells in blood (during visits 2, 5, 6 and 7) via ELISPot | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacteria bearing mutations in their DNA sequences in comparison with bacteria from the original inoculum administered during vaccination | — |
Countries
Switzerland