NCT06104345

Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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)

Conditions

• Vaccine-Preventable Diseases
• Typhoid Fever
• Cholera

Interventions

Type	Name	Description
BIOLOGICAL	Oral typhoid fever vaccine	Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4.
BIOLOGICAL	Oral cholera vaccine	Oral cholera vaccine (Dukoral®) on Days 0 and 7.

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2023-10-27
• Last updated: 2024-12-05

Locations

1 site across 1 country: Finland