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Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 ...

Jan 6, 2022 — The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic ...

https://www.faustmanlab.org/current-research/

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Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimerfor details.

ClinicalTrials.gov Identifier: NCT05180591

Recruitment Status : Recruiting

First Posted : January 6, 2022

Last Update Posted : April 4, 2022

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Sponsor:

Collaborator:

NYU Langone Health

Information provided by (Responsible Party):

Denise Louise Faustman, MD, Massachusetts General Hospital

Study Description

Brief Summary:

The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on pediatric Type 1 diabetes.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1Diabetes type1Autoimmune Diabetes	Biological: Bacillus Calmette-GuérinBiological: Saline Injection	Phase 2

Detailed Description:

Published Phase I data on repeat BCG vaccinations in long term adult type 1 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. The BCG vaccine also had beneficial metabolic effects that resets the utilization of sugars and significantly improves blood sugars by stably lowering HbA1c values for up to 8 years in subjects in the treatment group and not in the placebo group. In this Phase II Pediatric study, the investigators will attempt to test if even more significant effects can be seen in a pediatric population.

Eligible volunteers will either be vaccinated with BCG twice, one month apart or receive a placebo treatment. Both groups will be followed for five years.

Study Design

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Actual Study Start Date :	March 22, 2022
Estimated Primary Completion Date :	March 2027
Estimated Study Completion Date :	March 2027