Clinical Trial: Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics


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Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition	Treatment or Intervention	Phase
Insulin-Dependent Diabetes Mellitus Diabetes Mellitus	Vaccine: IBC-VS01	Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Official Title: Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus

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.

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)