Bacillus Calmette-Guerin: Phase I data

Researchers at Harvard and colleagues reported data from a double-blind, placebo-controlled, U.S. Phase I trial showing that 2 doses of a BCG vaccine led to transient increases in dead insulin autoreactive T cells - which normally attack and destroy insulin-producing pancreatic B cells in Type I diabetes - and Treg cells - which suppress the activity of autoreactive T cells. Additionally, the researchers said 1 placebo-treated patient unexpectedly developed acute Epstein-Barr virus (EBV) and subsequently also achieved transient increases in dead insulin autoreactive T cells and Treg cells. Additionally, C-peptide levels transiently increased from baseline to week 20 in the 2 BCG-treated patients by a mean of 3.49 and 2.57 pmol/L, respectively, and by a mean of 3.16 pmol/L in the placebo-treated patient who developed EBV infection compared to a mean of 1.65 pmol/L in reference diabetic subjects. The trial enrolled 6 patients with long-term Type I diabetes (mean of 15.3 years) and 6 healthy non-diabetic controls to receive 2 doses of a BCG vaccine or placebo administered 4 weeks apart. The researchers also compared the 6 long-term diabetics to 2 reference groups consisting of 57 patients with Type I diabetes and 16 healthy controls. ...