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GAD-alum (Diamyd) is an antigen-specific immunotherapy vaccine composed of recombinant human glutamic acid decarboxylase 65 (rhGAD65) formulated with an aluminum hydroxide (alum) adjuvant. It is designed to preserve pancreatic beta-cell function in patients with recent-onset type 1 diabetes mellitus by inducing immune tolerance to GAD65, a major autoantigen targeted by the immune system in the disease. By presenting the GAD65 antigen in a non-inflammatory context with alum, the therapy aims to modulate the autoimmune T-cell response and prevent further destruction of insulin-producing cells. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), through the TrialNet Study Group, has evaluated various dosing regimens of GAD-alum, including combinations with additional aluminum hydroxide, in Phase 2 clinical trials to determine its efficacy in preserving endogenous insulin production.
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