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ACTIVE NOT RECRUITING
NCT02081326
PHASE2

Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2015-06

Completion Date

2031-07

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Bacillus Calmette-Guérin

2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years

BIOLOGICAL

Saline injection

2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years

Locations (1)

Immunobiology Labs CNY 149

Charlestown, Massachusetts, United States