Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
Completed · Phase 1 · Has a placebo group
Conditions studied: Insulin-dependent Diabetes Mellitus, Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00057499
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 12
- Starts
- 2003-03-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2017-02-08
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with type 1 diabetes mellitus within 3 months prior to study entry
- Positive for IAA, GAD65, or IA2 antibodies OR positive for GAD65 or IA2 antibodies after 2 weeks of starting insulin treatment
You may not qualify if…
- History of treatment with any oral hypoglycemic agent for more than 3 months
- Ongoing use of medications known to influence glucose tolerance
- History of immunosuppressive or steroid therapy for more than 3 months within the 2 years prior to study entry
- Severe active liver, heart, kidney, or immunodeficiency disease that may limit life expectancy or may require immunosuppression during the study
- Prior complications related to routine vaccinations
- Prior participation in a trial for prevention of type 1 diabetes mellitus. Individuals who are known to have been in the placebo arm of a completed prevention trial are not excluded.
- Any condition that may interfere with a participant's ability to comply with the study
- Pregnancy or planned pregnancy within the time frame of the study
Where it is running
- Children's Hospital — Boston, Massachusetts, United States
- Joslin Diabetes Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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