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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: Completed Phase 1 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00564863 record still lists
NCT00564863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which CS19 expressing ETEC strain is the first listed.
NCT00564863 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00564863's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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