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NCT00844493 · ClinicalTrials.gov registry record · Phase 1
Low-dose Challenge Model With Enterotoxigenic E Coli
A Phase 1 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00844493 is a Phase 1 study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 30 participants.
The verdict
NCT00844493, a Phase 1 study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will validate a model for testing new vaccines designed to protect against intestinal infections with enterotoxigenic Escherichia coli (ETEC). ETEC is one of the most common causes of diarrhea in developing countries and is a common cause of travelers diarrhea. Vaccines are now being developed and their development will be facilitated if we have a valid model for testing these vaccines in human volunteers. We anticipate that the new vaccines will be given to volunteers and they will then be given a dose of virulent ETEC bacteria. If the vaccine is effective, the volunteers should not development diarrhea, but if the vaccine is not effective, the volunteers will have diarrhea for a few days. During this study, we will validate a minimum dose of virulent ETEC bacteria which is sufficient to cause diarrhea in healthy adult volunteers and to identify conditions that can make this model reliable. We will also determine, in a follow-up group of volunteers, if being exposed to the ETEC bacteria previously will protect against a subsequent illness when they are exposed to the same bacteria a second time. We believe that the previously exposed group will be protected and we will study the immune response to these exposures to help design vaccines that can accomplish this kind of protection.
Interventions
- BIOLOGICAL E coli strain H10407 and buffer
- BIOLOGICAL E coli H10407 and buffer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00844493
The ClinicalTrials.gov registry entry for NCT00844493 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 2 interventions - of which E coli strain H10407 and buffer is the first listed.
NCT00844493 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00844493 about?
NCT00844493 is a clinical study titled "Low-dose Challenge Model With Enterotoxigenic E Coli". This study will validate a model for testing new vaccines designed to protect against intestinal infections with enterotoxigenic Escherichia coli (ETEC). ETEC is one of the most common causes of diarrhea in developing countries and is a common cause of travelers diarrhea. Vaccines are now being deve...
What is the current status of trial NCT00844493?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-02. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00844493?
The interventions under investigation include: E coli strain H10407 and buffer (BIOLOGICAL), E coli H10407 and buffer (BIOLOGICAL).
Who is sponsoring clinical trial NCT00844493?
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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