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Home > "E" Clinical Trials Conditions > Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics  Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
For Condition: Diabetes Mellitus,Insulin-Dependent Diabetes Mellitus
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Immune Tolerance Network
Synopsis: 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.
Details: The vaccine in this study, IBC-VSO1, is a synthetic, metabolically inactive form of insulin designed to prevent pancreatic ß-cell destruction. It does not cause fluxuations in blood sugar. This study will evaluate whether the vaccine protects against autoimmune attack at the onset of T1DM, before pancreas function has deteriorated. This experimental treatment must occur early because 60% to 85% of ß-cells are already destroyed by the time of T1DM diagnosis. If ß-cell destruction can be halted, a prolonged remission period after diagnosis may occur, with a subsequent delay in diabetes-related complications. Participants must have been diagnosed with T1DM for no more than 1 month at the time of enrollment in this study. Participants will be randomized to either a vaccine group or a control group. Participants in the vaccine group will receive one injection of IBC-VS01; participants in the control group will receive a placebo. Participants will then be monitored for 2 years. Participants will have ten follow-up visits, which will include blood tests for immunological and genetic analysis. Throughout the study, metabolic tests are also performed to measure the remaining capacity of self insulin production of the body.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/35 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Diagnosed with type 1 diabetes mellitus within 30 days prior to study entry Exclusion Criteria - History of treatment with oral hypoglycemic agents or ongoing use of medications known to influence glucose tolerance - Complications related to routine vaccinations - Pregnancy or planned pregnancy within the time frame of the study - Prior participation in a trial for prevention of type 1 diabetes mellitus (unless the individual is known to have been in the placebo arm of a completed prior prevention trial)
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
TihamerOrban, Principal Investigator, Joslin Diabetes Center
Children's Hospital *Recruiting*
Boston, Massachusetts,
United States
Recruiting
Joslin Diabetes Center *Recruiting*
Boston, Massachusetts,
United States
Recruiting
Additional Information:
Study ID Numbers: ITN-012AI; DAIT BD012
Study Start Date: March 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057499
Other Diabetes Mellitus Studies:
1. African-American Diabetes Intervention Project
2. Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
Related Studies:
Other Diabetes Mellitus Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
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