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Study to evaluate the immune responses against Salmonella Typhi after vaccination with Vivotif®

Open, controlled monocentric clinical study to evaluate the specific immune responses against Salmonella Typhi porins after vaccination with the commercial live oral typhoid vaccine Ty21a Vivotif®

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18360696
Enrollment
20
Registered
2015-08-13
Start date
2015-06-15
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Typhoid fever caused by Salmonella Typhi Infections and Infestations

Interventions

1. Vaccinated group (n=15): Vivotif® (Typhoid Vaccine Live Oral Ty21a) is a live attenuated vaccine for oral administration only. The vaccine contains the attenuated strain Salmonella Typhi Ty21a. Thr

Sponsors

Kantonsspital St.Gallen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime frame
Bacteria bearing mutations in their DNA sequences in comparison with bacteria from the original inoculum administered during vaccination

Countries

Switzerland

Contacts

Public ContactWerner Albrich
werner.albrich@kssg.ch+41 (0)71 494 26 53

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026