Mucosal insulin vaccination for type 1 diabetes prevention.

Mucosal administration of autoantigen, if efficacious, is an attractive therapeutic approach for prevention of type 1 diabetes. It can prevent or delay autoimmune diabetes in animal models, but although shown to be safe has not yet been proven effective in human studies. Efficacy may depend upon the dose and route at which antigen is administered, the stage in type 1 diabetes pathogenesis at which treatment is initiated, and the study cohort that is treated. Here we address these issues and propose a clinical translation possibility for mucosal insulin administration in genetically at risk individuals.