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NCT01147445 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of ETEC Vaccine
A Phase 1 study of Gastroenteritis Escherichia Coli, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT01147445 is a Phase 1 study of Gastroenteritis Escherichia Coli that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT01147445, a Phase 1 study of Gastroenteritis Escherichia Coli, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli infection) is safe. This vaccine will be tested to see what effects it has on the body and the ability of the vaccine to help the body resist disease. Researchers want to find the highest dose of dmLT vaccine that can be given without causing severe side effects. Most E. coli bacteria are harmless to humans and can even be beneficial. However, some are harmful, and can cause diarrhea. About 32 healthy adults, ages 18-45, will participate in this study. This study will require volunteers to stay in the research facility for several nights. Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures include: stool samples, blood samples, and documenting side effects. Participants will be involved in study related procedures for about 8 months.
Conditions Studied
Interventions
- BIOLOGICAL Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
Study Locations (2)
Maryland
- University of Maryland, School of Medicine, Center for Vaccine Development and Global Health - Baltimore
Ohio
- Cincinnati Children's Hospital Medical Center - Gastroenterology, Hepatology and Nutrition - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-09-13 |
| Est. Completion | 2012-06-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01147445
The ClinicalTrials.gov registry entry for NCT01147445 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 1 condition, with Gastroenteritis Escherichia Coli appearing as the primary indexed condition, and to 1 intervention - of which Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine is the first listed.
NCT01147445 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT01147445 about?
NCT01147445 is a clinical study titled "Phase I Study of ETEC Vaccine". The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli infection) is safe. This vaccine will be tested to see what effects it has on the body and the ability of the vaccine to help the body resist disease. Researchers want to find the highest dose of dmLT vacci...
What is the current status of trial NCT01147445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2010-09-13. Estimated completion is 2012-06-08.
What conditions does trial NCT01147445 study?
This clinical trial studies the following conditions: Gastroenteritis Escherichia Coli.
What interventions are being tested in trial NCT01147445?
The interventions under investigation include: Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01147445?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01147445 being conducted?
This trial has 2 study locations across Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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