Conditions: Type 1 Diabetes Mellitus
Keywords: immune tolerance immunotherapy antigen-specific tolerance vaccine induced tolerance Beta-cell function T-cells DPT-1 treatment of type 1 diabetes new onset type 1 diabetes juvenile diabetes T1D diabetes mellitus Type 1 diabetes TrialNet TrialNet
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 145
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM).

Detailed description:
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas called islet cells). As these cells are destroyed, the body's ability to produce insulin decreases. Glutamic acid decarboxylase (GAD) is one of the major autoantigens (a protein that the immune system is reacting to) involved in the autoimmune process underlying T1DM.

GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator. Previous studies have shown that it may slow or prevent autoimmune destruction of pancreatic islet cells by introducing "immune tolerance". By administering excess autoantigen, the body may stop its attack on its own cells that produce insulin. If the immune system's attack can be halted in a patient with recent onset T1DM, than residual insulin secretion may be maintained. This may be beneficial in decreasing acute and long-term diabetic complications as well as improving glucose control.

Arms:
arm 1: 3 injections of GAD-Alum vaccine arm 2: 2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone arm 3: 3 injections of Aluminum hydroxide alone

Interventions: intervention 1: GAD-Alum intervention 2: GAD-Alum and Aluminum hydroxide intervention 3: Aluminum hydroxide
Intervention descriptions: intervention 1: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart. intervention 2: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection. intervention 3: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.

Protocol document: