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NCT00057499 · ClinicalTrials.gov registry record · Phase 1
Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00057499 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 12 participants.
The verdict
NCT00057499, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels. T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune system attacks the body itself. In addition to regulating blood sugar, insulin may have the ability to protect cells in the pancreas from attack by the immune system. This study will evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction. Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or slowing of the ongoing autoimmunity, and this will result in an appreciable difference in functioning B cell mass compared to the placebo treated group by the end of the study.
Interventions
- BIOLOGICAL IBC-VS01
- BIOLOGICAL IBC-VS01 placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2003-03 |
| Est. Completion | 2007-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00057499
The ClinicalTrials.gov registry entry for NCT00057499 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 2 interventions - of which IBC-VS01 is the first listed.
NCT00057499 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00057499 about?
NCT00057499 is a clinical study titled "Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics". Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels. T1DM is an autoimmune disease. ...
What is the current status of trial NCT00057499?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2003-03. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00057499?
The interventions under investigation include: IBC-VS01 (BIOLOGICAL), IBC-VS01 placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT00057499?
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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