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The human glutamic acid decarboxylase 65 (hGAD65) DNA vaccine is an experimental, preclinical plasmid DNA vaccine designed for the prevention of type 1 diabetes (autoimmune diabetes). Developed primarily in an academic research setting at the Second Xiangya Hospital of Central South University in China, the vaccine consists of a plasmid vector (such as pcDNA3.1) encoding the human GAD65 autoantigen (gene GAD2). In preclinical studies using non-obese diabetic (NOD) mice, intramuscular administration of the vaccine significantly reduced the incidence of diabetes, decreased insulitis, and prevented pancreatic beta-cell apoptosis. The therapeutic mechanism involves downregulating NF-ATp and upregulating NF-ATc and interleukin-4 (IL-4), which shifts the T-helper cell response toward a protective Th2 phenotype, thereby inducing immune tolerance to the GAD65 autoantigen.
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