THU284 BCG Clinical Trial Programs In Advanced Type 1 Diabetes - 2023 Update

Disclosure: W.M. Kühtreiber: None. E. Hostetter: None. A.H. Lee: None. N. Ng: None. G. Wolfe: None. A. Aristarkhova: None. J. Braley: None. H. Zheng: None. D.L. Faustman: None. The bacillus Calmette-Guerin (BCG) vaccine, first introduced a century ago for tuberculosis prevention, is today being tested in double-blinded, randomized clinical trials for treatment of diverse forms of autoimmunity, including type 1 diabetes (T1D) and multiple sclerosis (MS). There are multiple clinical protocols underway at our institution testing various aspects of BCG’s ability to lower HbA1c, reduce insulin requirements and change day-to-day fluctuations in blood sugars, including: 1) Ten-year follow up of a Phase I study of BCG vaccination in longstanding T1D to study the durability of lowered HbA1c values after BCG treatment; 2) Randomized, double-blinded Phase II clinical trial testing the BCG vaccine in adults with longstanding T1D to demonstrate the reproducibility of BCG’s effects seen in the Phase I trial; 3) Radiologic study to quantify and identify through FDG-CAT scans the organs and organ systems that utilize more sugar after BCG treatment; 4) Study in adults with longstanding T1D to evaluate the effects of two doses of BCG compared to 6 doses of BCG over 5 years of observation; and 5) A multi-center clinical trial of adolescents with > 2 years since T1D diagnosis to evaluate the potential benefits of BCG vaccination. To date, we have enrolled 295 patients as part of a planned enrollment of 500, including 272 BCG-vaccinated patients. Global studies on the effects of BCG on the immune system show that the impact of multi-dose vaccination in MS and T1D is optimized by at least 2 years of follow up and that the effects appear durable without further treatment in both MS and T1D to 5+ years. BCG vaccine therapy may provide a safe and affordable medical intervention in individuals with longstanding autoimmunity. Presentation: Thursday, June 15, 2023