Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06104345
Other study ID # Dukoral+Vivotif
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 2023
Est. completion date December 2025

Study information

Verified date October 2023
Source Helsinki University Central Hospital
Contact Anu Kantele, MD, PhD
Phone +358503097640
Email anu.kantele@hus.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore the coadministration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines in healthy volunteers aged 18-65 years. The main question it aims to answer is: • Does coadministration impact the immune responses to Vivotif® and Dukoral® vaccines Participants will: - receive either oral typhoid fever (Vivotif®) or oral cholera (Dukoral®) vaccines or both simultaneously - give blood samples for immunogenicity analyses - participate in adverse event follow up Researchers will compare those receiving only one of the vaccines to those receiving both simultaneously to see if coadministration has an impact on antigen-specific responses measured with: - ELISPOT (plasmablast responses specific to Salmonella typhi, Vibrio Cholerae and Enterotoxigenic Escherichia coli) - ELISA (antibodies in lymphocyte supernatants (ALS) and serum antibodies specific to vaccine antigens)


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Male or female subjects aged =18 to =65 years. 2. General good health as established by medical history and physical examination. 3. Written informed consent. 4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study (14 days before immunization to day 28 ± 3). Abstinence is acceptable. 5. Available for all visits scheduled in this study. Exclusion Criteria: 1. Vaccination against typhoid fever or cholera within 5 years before dosing. 2. History of clinical typhoid fever or cholera. 3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study period or vaccination planned during it. 4. Current intake of antibiotics or end of antibiotic therapy <8 days before first IMP administration. 5. Chronic (longer than 14 days) administration of immunosuppressants or other immunemodifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids allowed. 6. Acute or chronic clinically significant gastrointestinal disease. 7. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 8. Pregnancy or lactation. 9. Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever (fever defined as body temperature of =38 °C). 10. Alcohol or drug abuse. 11. Suspected non-compliance. 12. Use of any investigational drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. 13. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator. 14. Employee at the investigational site or relative or spouse of the investigator. 15. Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate in the study, a subject's well-being, or the outcome of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Oral typhoid fever vaccine
Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4.
Oral cholera vaccine
Oral cholera vaccine (Dukoral®) on Days 0 and 7.

Locations

Country Name City State
Finland Meilahti Vaccine Research Center, Helsinki University Hospital Helsinki

Sponsors (2)

Lead Sponsor Collaborator
Helsinki University Central Hospital University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Titer of antigen-specific serum antibodies to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines. Measurement of anti-salmonella, anti-cholera and anti-ETEC antibodies in serum (ELISA) Blood samples on Days 0 and 28 ± 3 for all participants.
Primary Magnitude of antigen-specific plasmablast responses to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines (ASCs/million PBMCs) Measurement of IgA -, IgG- and IgM-secreting antibody cells (ASC ELISPOT) specific to Salmonella typhi (whole cell), Vibrio cholerae (whole cell and CTB-toxin) and Enterotoxigenic Escherichia coli (ETEC whole cell and LTB-toxin). Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.
Secondary Titer of antigen-specific antibodies in lymphocyte supernatants (ALS) to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines. Measurement of anti-salmonella, anti-cholera and anti-ETEC antibodies in ALS samples (ELISA) Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.
See also
  Status Clinical Trial Phase
Completed NCT01895855 - Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera Phase 3
Completed NCT01339845 - Introduction of Cholera Vaccine in Bangladesh N/A
Recruiting NCT05829772 - Impact Study of Cholera Vaccination in Endemic Areas - Seroprevalence
Completed NCT04760236 - Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™ Phase 3
Recruiting NCT04326478 - Single Dose Azithromycin to Prevent Cholera in Children Phase 2
Completed NCT02928341 - Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo N/A
Completed NCT02864433 - Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
Recruiting NCT06003816 - Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI) N/A
Not yet recruiting NCT05771779 - Co-administration Study of OCV, TCV and MR Phase 3
Not yet recruiting NCT06455852 - Correlates of Protection for Cholera N/A
Completed NCT04150250 - Cholera Anti-Secretory Treatment Trial Phase 2
Terminated NCT00624975 - Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants Phase 2
Completed NCT00226616 - Zinc Supplementation in Cholera Patients Phase 3
Completed NCT03373669 - Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine Phase 4
Completed NCT02094586 - A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults Phase 3
Completed NCT02100631 - A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults Phase 3
Completed NCT01823939 - PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera Phase 1
Completed NCT01365442 - Pilot Introduction of Oral Cholera Vaccine in Orissa, India N/A
Completed NCT00128011 - Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine Phase 2
Completed NCT00672308 - Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults Phase 2