The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained. Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years, or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas. An additional adaptive trial for COVID-19 is also being conducted on these randomized double blinded type 1 diabetic subjects receiving BCG or placebo injections. An expanded study arm has been approved for repeat dosing of BCG in adult Type I diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years
2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years
Immunobiology Labs CNY 149
Charlestown, Massachusetts, United States
Change in HbA1c values in juvenile onset type 1 diabetics
A change in the hemoglobin A1c (HbA1c) measurement compared to self
Time frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection
Insulin use in juvenile onset type 1 diabetics (AOO<21 years)
A change in insulin (IDAA1c) use as reported at study visits compared to self in juvenile onset type 1 diabetes.
Time frame: 4 weeks and 1, 2, 3, 4, and 5 years after initial BCG/placebo injection
Endogenous insulin levels in the blood in juvenile onset type 1 diabetics (AOO<21 years)
A change in c-peptide and proinsulin levels (as an analog for endogenous insulin) in the blood compared to self.
Time frame: 4 weeks and 1, 2, 3, 4, and 5 years after initial BCG/placebo injection
Autoimmunity in juvenile onset type 1 diabetes (AOO<21 years)
A change in autoantibodies and autoreactive T cells to monitor the drug mechanism for autoimmune changes.
Time frame: 4 weeks and 1, 2, 3, 4, and 5 years after initial BCG/placebo injection
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