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Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers

Study acronym: PanChol
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later across 2 updates Jan 31, 2026 → Nov 30, 2026
See other at-risk trials from Centre for Infectious Disease Research in Zambia

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 25 words
  2. Primary completion pushed from Jan 31, 2026 to Aug 31, 2026v3 Show 4 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Oct 1, 2025 to May 20, 2026
    • Study completion pushed from Jan 31, 2026 to Jan 31, 2027
    • Site details revised
  3. Eligibility criteria shortened, about 46 words
    • Secondary endpoints: details revised at 1 of 2 entries
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Cholera is a serious diarrheal disease that can be fatal within hours of onset. The current available cholera vaccines to prevent the disease are not very effective. Panchol is a new oral cholera vaccine that may be an improvement over the currently available vaccines in use. The goal of this study is to learn safety of this new oral cholera vaccine and the body's immune response to the vaccine. The researchers will compare the PanChol vaccine to placebo to see the side effects experienced in participants. The participants will be adults aged between 18 and 55 years and they will be required to: 1. Be admitted to hospital until they stop passing the cholera vaccine in their stool. During admission, all side effects will be recorded by the researchers. 2. After discharge, the participants will visit the research site every month for 3 months with an optional visit at the 4th month for the researchers to assess the participants' general health.
Trial Details
NCT Number NCT07107516
Lead Sponsor Centre for Infectious Disease Research in Zambia
Conditions
(from sponsor)		 Cholera Vaccination Reaction
Related terms Cholera
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov