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NCT03971669 · ClinicalTrials.gov registry record · Phase 4
Blood Donor CVD 5000
A Phase 4 study of Risk Reduction, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT03971669: Recruiting Phase 4 study of Risk Reduction, sponsored by University of Maryland, Baltimore.
NCT03971669 is a Phase 4 study of Risk Reduction that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 150 participants, below the 3,687-participant average among 13 other Risk Reduction trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03971669, a Phase 4 study of Risk Reduction, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
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
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-01-16 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 4 |
What NCT03971669 shows while recruiting
NCT03971669 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 3,687-participant average among 13 other Risk Reduction trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Risk Reduction appearing as the primary indexed condition, and to 1 intervention - of which Vivotif Typhoid Oral Vaccine is the first listed.
NCT03971669 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03971669 about?
NCT03971669 is a clinical study titled "Blood Donor CVD 5000". This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens ov...
What is the current status of trial NCT03971669?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2004-01-16. Estimated completion is 2030-06-30.
What conditions does trial NCT03971669 study?
This clinical trial studies the following conditions: Risk Reduction.
What interventions are being tested in trial NCT03971669?
The interventions under investigation include: Vivotif Typhoid Oral Vaccine (DRUG).
Who is sponsoring clinical trial NCT03971669?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03971669 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
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Where NCT03971669's enrollment target sits among peer trials
150 6th of 13 higher than 8 of 13 other Risk Reduction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Risk Reduction 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.
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