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Safety and Immunogenicity Study of the DuoChol Oral Cholera Vaccine in Healthy Participants

Study acronym: DuoChol
StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Mar 2026 to Jul 2027
    • Start date: Dec 2025 to Jan 2027
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this phase I, open-label, randomized, active-controlled Trial is to evaluate the safety and immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old healthy participants in Sweden. This first-in-human study is intended to obtain initial data on the DuoChol oral cholera vaccine safety and its effect on immune responses in a cholera non-endemic setting to guide future studies in cholera endemic population. The Investigators will evaluate the safety and immunogenicity after each dose vaccination of DuoChol Oral Cholera Vaccine/Dukoral®. The participants will be randomly assigned to receive 2 vaccinations at 14-day intervals of DuoChol or Dukoral® in a 2:1 ratio. Participants in the DuoChol arm will receive one capsule of DuoChol on days 0 and 14. Participants in the Dukoral® arm will receive the standard dose as indicated in the Dukoral® package insert. The Investigators will follow-up the participants for 4 weeks after the second vaccination. The study is funded by Wellcome Trust, grant number : 226726/Z/22/Z.
Trial Details
NCT Number NCT07270796
Lead Sponsor International Vaccine Institute
Conditions
(from sponsor)		 Cholera Vaccination Reaction
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov