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NCT00564863 · ClinicalTrials.gov registry record · Phase 1
Dose-Finding Study of CS19 Expressing ETEC Challenge Strains
A Phase 1 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00564863 is a Phase 1 study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 25 participants.
The verdict
NCT00564863, a Phase 1 study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This will be a strain and dose-finding study in which CS19-ETEC strain WS0115A will be administered at a starting inoculum of 5 x 108 colony forming units (cfu) to 5 subjects as the initial step to establish a human disease model. If an 80% attack rate (AR) for predefined diarrheal disease is achieved without high output diarrhea, the same inoculum will be given to 5 - 10 more subjects for confirmation of AR. If an 80% AR is not achieved, AR and severity of disease will be evaluated to determine if the dose should be increased. The same sequence may be conducted with DS26-1 as necessary. If the WS0115A strain causes high output diarrhea, the dose will be adjusted down and further dose characterization continued. An iterative process will be used to select the optimal strain and dose with each step reviewed and approved by the medical monitor.
Interventions
- BIOLOGICAL CS19 expressing ETEC strain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-09-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00564863
The ClinicalTrials.gov registry entry for NCT00564863 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CS19 expressing ETEC strain is the first listed.
NCT00564863 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00564863 about?
NCT00564863 is a clinical study titled "Dose-Finding Study of CS19 Expressing ETEC Challenge Strains". This will be a strain and dose-finding study in which CS19-ETEC strain WS0115A will be administered at a starting inoculum of 5 x 108 colony forming units (cfu) to 5 subjects as the initial step to establish a human disease model. If an 80% attack rate (AR) for predefined diarrheal disease is achiev...
What is the current status of trial NCT00564863?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2007-09. Estimated completion is 2008-09-04.
What interventions are being tested in trial NCT00564863?
The interventions under investigation include: CS19 expressing ETEC strain (BIOLOGICAL).
Who is sponsoring clinical trial NCT00564863?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
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