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. 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.
Insulin-dependent Diabetes Mellitus
Biological: IBC-VS01 placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus|
- Clinical endpoints including adverse events, local reactions, routine physical exams, insulin dose, and laboratory tests [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- C-peptide levels in response to mixed meal tolerance test [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- HbA1c, GAD65Ab, IAA, IA2Ab, GAD65Ab isotypes [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- CD4- and CD8- Va24JaQ+ [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- T cells' secretion of IL-4 and INF-gamma [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2003|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Experimental: IBC-VS01 vaccine
IBC-VS01 vaccine is dministered twice.
Placebo Comparator: Control Group
IBC-VS01 placebo is administered twice
Biological: IBC-VS01 placebo
The vaccine in this study, IBC-VSO1, is a synthetic, metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction. It does not cause fluctuations 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 beta-cells are already destroyed by the time of T1DM diagnosis. If beta-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 3 months at the time of enrollment in this study. Participants will be randomly assigned 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 will also be performed to measure the remaining capacity of self insulin production of the body.
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Tihamer Orban, MD||Joslin Diabetes Center|