Trial intelligence / Profile preview

Immune Response of Concomitant Vivotif and Dukoral Vaccines

NCT06104345Phase 4

Key facts

Status
Completed
Start
Oct 2023
Primary completion
Jun 2024
Countries
1
Sponsor
Helsinki University Hospital
Modality
Vaccines & Immunotherapeutics
Conditions
typhoid fevercholera
01

Overview

Phase 4, randomised, open-label trial in typhoid fever and cholera comparing Vivotif, Dukoral and Dukoral+Vivotif (3 arms). Primary endpoint: Magnitude of antigen-specific plasmablast responses to oral typhoid fever and cholera vaccines. Started Oct 2023; status: completed.

02

Design

3 arms
Study design
RandomizedOpen-label
  • Vivotif

    Three oral doses of typhoid fever vaccine (Vivotif) on Days 0, 2 and 4.

  • Dukoral

    Two oral doses of cholera vaccine (Dukoral) on Days 0 and 7.

  • Dukoral+Vivotif

    Oral typhoid fever and cholera vaccines administered simultaneously according to their schedules.

03

Who it enrols

Healthy volunteers aged 18-65 without recent typhoid/cholera vaccination or antibiotic/immunosuppressant use.

04

Endpoints

Primary

  • Magnitude of antigen-specific plasmablast responses to oral typhoid fever and cholera vaccines

Secondary

  • Titer of antigen-specific antibodies in lymphocyte supernatants (ALS)

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