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

• Register: ISRCTN
• Last refreshed on: 18 September 2023
• Main ID: ISRCTN18360696
• Date of registration: 13/08/2015
• Prospective Registration: No
• Primary sponsor: Kantonsspital St.Gallen Hospital
• Public title: Study to evaluate the immune responses against Salmonella Typhi after vaccination with Vivotif®
• Scientific title: 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®
• Date of first enrolment: 15/06/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN18360696
• Study type: Interventional
• Study design: Open interventional study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Switzerland

Contacts

• Name: Werner Albrich

• Name: Burkhard Ludewig

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Typhoid fever caused by Salmonella Typhi
Infections and Infestations

Intervention(s)

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. Three doses of the vaccine are to be administered in alternate days (1, 3 and 5)
2. Untreated group (n=5): No vaccine/treatment/placebo will be administered to this group

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

14/039

Source(s) of Monetary Support

Kantonsspital St Gallen (Switzerland), Gottfried und Julia Bangerter-Rhyner-Stiftung

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; the Ethikkommission des Kantons St. Gallen, 06/07/2015, ref: EKSG 15/085

Results

• Results available: Yes
• Date Completed: 01/10/2015