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NCT03724357 · ClinicalTrials.gov registry record · Phase 4
Blood Donor CVD 9000
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT03724357: Clinical Trial Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT03724357 is a Phase 4 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03724357, a Phase 4 study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood 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
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine.
Interventions
- DRUG Vaxchora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-11-04 |
| Est. Completion | 2021-10-28 |
| Phase | Phase 4 |
Why NCT03724357 stopped before completion
NCT03724357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Vaxchora is the first listed.
NCT03724357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03724357 about?
NCT03724357 is a clinical study titled "Blood Donor CVD 9000". This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood specimens over a follow-up ti...
What is the current status of trial NCT03724357?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2018-11-04. Estimated completion is 2021-10-28.
What interventions are being tested in trial NCT03724357?
The interventions under investigation include: Vaxchora (DRUG).
Who is sponsoring clinical trial NCT03724357?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03724357's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 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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