Clinical trials are now evaluating the value of the BCG vaccine in the prevention and treatment of this and other immune conditions. Information provided by (Responsible Party): Denise Louise Faustman, MD, Massachusetts General Hospital, No Study Results Posted on ClinicalTrials.gov for this Study. 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. ScienceDirect ® is a registered trademark of Elsevier B.V. ScienceDirect ® is a registered trademark of Elsevier B.V. Faustman and colleagues are recruiting type 1 diabetes patients for a phase II clinical trial of the BCG vaccine; the study will not start until funding becomes available. This has led to the discovery of novel antibodies to correct this misregulation as well as a drug screening initiative to discover a role for existing and affordable therapies. By continuing you agree to the use of cookies. The discovery that individuals with type 1 diabetes … Copyright © 2018 Elsevier Inc. All rights reserved. BCG contains the avirulent tuberculosis strain Mycobacterium bovis and produces a response in the vaccinated host driven in part by induction of tumor necrosis factor (TNF). Induction of TNF through BCG vaccination or through selective agonism of TNF receptor 2 (TNFR2) has demonstrated desirable cellular immune effects in preclinical and clinical trials in type 1 diabetes. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Copyright © 2020 Elsevier B.V. or its licensors or contributors. Please remove one or more studies before adding more. COVID-19 is an emerging, rapidly evolving situation. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). About a decade after BCG was first studied in humans with type 1 diabetes, a double-blind, placebo-controlled phase I trial of repeat BCG vaccination was conducted in adults with long-standing type 1 diabetes (mean duration of diabetes: 15.3 years) at a single center in the United States. About Study Results Reporting on ClinicalTrials.gov, U.S. Department of Health and Human Services. The Value of BCG and TNF in Autoimmunity (Second Edition), https://doi.org/10.1016/B978-0-12-814603-3.00002-1. We therefore divided a group of 100 T1D subjects into the highest 50% and the lowest 50% based on … The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 14 Six type 1 diabetic subjects were randomly assigned to BCG or placebo (two injections spaced 4 weeks apart) … However, interest in this old vaccine has recently grown for potential new uses in certain forms of autoimmunity, including type 1 diabetes. After an onset delay, repeat BCG vaccination was associated with stable, long-term lowering of HbA1c in type 1 diabetes for > 5 years without hypoglycemia. The Potential of TNF Induction From BCG for the Treatment of Type 1 Diabetes. Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. ClinicalTrials.gov Identifier: NCT02081326. One of these effects is the selective death of autoreactive T cells that cause disease. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The second is the expansion of beneficial regulatory T cells (Tregs) that can help to restore immune balance. In patients with a mean disease duration of 15 years, a phase I trial showed that two BCG vaccinations spaced 4 weeks apart selectively eliminated autoreactive T cells, induced beneficial Tregs, and allowed for a small, transient restoration of insulin production. T he BCG vaccine against tuberculosis can reverse Type 1 diabetes to almost undetectable levels, an eight-year study has shown. We use cookies to help provide and enhance our service and tailor content and ads. The Faustman Lab has identified a key family of immune cells responsible for regulating the immune response. For example, in type 1 diabetes, the insulin-producing cells in the pancreas are attacked by autoreactive T cells. In human clinical trials, administration of the BCG vaccine to adults with long-standing type 1 diabetes appears to have great promise. These findings support the hygiene hypothesis, which suggests that early life exposure to microbes is actually beneficial to the development of the immune system and is an important determinant of sensitivity to autoimmune diseases such as type 1 diabetes. Nearly a century old, the Bacille Calmette-Guérin (BCG) vaccine is best known for its global use in tuberculosis prevention. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Why Should I Register and Submit Results? Continuing study of the BCG vaccine and early but advancing studies of TNFR2 agonism pathway for BCG-induced tolerance suggest a path forward for possible immune reversal of the type 1 diabetic autoimmune process. Since BCG treatment lowers blood sugars leading to lowered HbA1c values, it was important to rule out metabolically that blood sugar control was the consequence, not the cause, of the shift in type 1 diabetes (T1D) lymphocytes from high oxidative phosphorylation to aerobic glycolysis.
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