In recent years, however, the mechanism of action underlying the therapeutic potential of BCG and TNF in autoimmune disease has been further elucidated [1], supporting the hypothesis based on animal data that BCG vaccination may be beneficial in type 1 diabetes, especially if the mechanism of action of BCG trigger TNF can be closely followed with sophisticated and early biomarkers of safety. The gene discussed is TNF; the disease is type 1 diabetes mellitus.