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NCT00654108 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT00654108 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 62 participants.
The verdict
NCT00654108, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
Enterotoxigenic Escherichia (E.) coli (ETEC) bacteria are the main cause of traveler's diarrhea and are significant pathogens affecting children and elderly individuals of developing countries. The purpose of the study is to determine the safety of the ETEC-Cholera vaccine and the body's ability to protect itself against ETEC and cholera infection after receiving the vaccine. The study will enroll a total of 64 healthy volunteers, 18 to 45 years old at the Cincinnati Children's Hospital. The study will provide increasing doses of the vaccine or placebo (inactive substance) to 4 groups consisting of 16 participants each. Participants will remain in the inpatient unit for observation for about 11 days. All subjects will be treated with Cipro, an antibiotic, for 5 days. Study procedures include: blood samples, vital signs, physical examinations, and stool samples. Volunteers will be involved in the study for about 8 months including telephone contacts.
Interventions
- DRUG Ciprofloxacin
- BIOLOGICAL Peru-15-pCTB
- OTHER Sodium bicarbonate/Ascorbic Acid/Aspartame Buffer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2008-06-02 |
| Est. Completion | 2010-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00654108
The ClinicalTrials.gov registry entry for NCT00654108 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ciprofloxacin is the first listed.
NCT00654108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00654108 about?
NCT00654108 is a clinical study titled "Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects". Enterotoxigenic Escherichia (E.) coli (ETEC) bacteria are the main cause of traveler's diarrhea and are significant pathogens affecting children and elderly individuals of developing countries. The purpose of the study is to determine the safety of the ETEC-Cholera vaccine and the body's ability to ...
What is the current status of trial NCT00654108?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2008-06-02. Estimated completion is 2010-12-31.
What interventions are being tested in trial NCT00654108?
The interventions under investigation include: Ciprofloxacin (DRUG), Peru-15-pCTB (BIOLOGICAL), Sodium bicarbonate/Ascorbic Acid/Aspartame Buffer (OTHER).
Who is sponsoring clinical trial NCT00654108?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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