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CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study Identification, Study Status, Oversightv8
  2. Notable Primary and study completion dates: Jun 30, 2024 to Aug 1, 2027v7
  3. Minor 2 versions Re-verified since Nov 9, 2022, no change to tracked fieldsv5-v6
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 260 to confirmed 87
    • Site details revised
    v4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Lead sponsor: University of Maryland to University of Maryland, Baltimorev2
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups: Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination. The Vivotif typhoid vaccine used in this study is 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 vaccine.
Trial Details
NCT Number NCT03970304
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)
Typhoid Vaccination
Enrollment 87 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov