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CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Primary and study completion dates: May 31, 2025 to May 31, 2029v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary and study completion dates: Oct 2023 to May 31, 2025
    • Site contact updated
    v7
  5. 3 versions Re-verified since Apr 13, 2021, no change to tracked fieldsv4-v6
Show 2 earlier versionsHide 2 earlier versions
  1. Lead sponsor: University of Maryland to University of Maryland, Baltimorev3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2018 to Nov 5, 2018
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups: Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination. Both vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and/or cholera vaccine.
Trial Details
NCT Number NCT03705585
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)		 Typhoid and/or Cholera Vaccination
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov