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NCT03970304 · ClinicalTrials.gov registry record · Phase 4
CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults
A Phase 4 study of Typhoid Vaccination, sponsored by University of Maryland, Baltimore.
- Active
- Registry status
- Phase 4
- Development phase
- 87
- Enrollment target
- 1
- Study location
NCT03970304: Active Phase 4 study of Typhoid Vaccination, sponsored by University of Maryland, Baltimore.
NCT03970304 is a Phase 4 study of Typhoid Vaccination that is active but no longer recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 87 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03970304, a Phase 4 study of Typhoid Vaccination, is active but no longer recruiting, sponsored by University of Maryland, Baltimore.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 87 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Percentage of responders by cytokine production (Interferon-gamma (IFN-gamma) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry. Responders will be defined as those volunteers showing increases post-immunization of \>0.1% of positive CD8+ cells for IFN-gamma or TNF-α over baseline (pre-immunization) values.) or Tumor Necrosis Factor-alpha (TNF-α)) by mass cytometry or flow cytometry.
Conditions Studied
Interventions
- DRUG Vivotif Typhoid Oral Vaccine
Study Locations (1)
Maryland
- Universtiy of Maryland, Baltimore, Center for Vaccine Development and Global Health - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2013-10-24 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 4 |
What the registry record for NCT03970304 still lists
NCT03970304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Typhoid Vaccination appearing as the primary indexed condition, and to 1 intervention - of which Vivotif Typhoid Oral Vaccine is the first listed.
NCT03970304 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03970304 about?
NCT03970304 is a clinical study titled "CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults". 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 vac...
What is the current status of trial NCT03970304?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 87 participants. The study started on 2013-10-24. Estimated completion is 2027-08-01.
What conditions does trial NCT03970304 study?
This clinical trial studies the following conditions: Typhoid Vaccination.
What interventions are being tested in trial NCT03970304?
The interventions under investigation include: Vivotif Typhoid Oral Vaccine (DRUG).
Who is sponsoring clinical trial NCT03970304?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03970304 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03970304's enrollment target sits among peer trials
87 923rd of 2000 higher than 1,076 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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