Repeat BCG Vaccinations for the Treatment of Pediatric Type 1 Diabetes

Brief description of study

This research study will learn more about whether the Bacillus Calmette–Guérin (BCG) vaccine can help people with type 1 diabetes and improve blood sugar control. This research study will compare one group of pediatric diabetics who will receive two BCG vaccinations to another group of pediatric diabetics who will receive two placebo vaccinations. The placebo vaccine looks exactly like the BCG vaccines, but contains no active vaccine. During this study, you may get a placebo instead of one of the BCG vaccines. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. If you decide to join this research study, it will take you about 5 years to complete the study. During this time, we will ask you to make 13 study visits to Massachusetts General Hospital (MGH) and/or NYU Langone Hospital-Long Island Diabetes Center as well as 4 remote study visits via video conference


Clinical Study Identifier: s19-01527
ClinicalTrials.gov Identifier: NCT05180591


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