Diabetes, Heart and Cardiovascular Diseases News Chronicle.  Diabetes, Cardiovascular and Heart Diseases
 Article 341
    Published on July 26, 2018

BCG vaccine provides long-term reversal of type 1 diabetes

Type 1 diabetes (T1D) is a chronic autoimmune disease affecting about 30,000 people in the United States every year. JDRF says about three million people are affected by the type 1 diabetes (T1D) in the United States. An individual with type 1 diabetes is at an enhanced risk of heart diseases (such as heart attack and stroke) and hypoglycemia (low blood sugar levels) events. Earlier studies show the risk of heart diseases can be reduced by about one-third for every ten percent drop in the A1c levels.

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Long-term clinical trials and follow-up studies have got successful results in curing type 1 diabetes (or reinstating near-normal blood sugar levels) with the bacillus Calmette-Guerin (BCG) vaccine (a tuberculosis vaccine). The BCG vaccine is a cheap and oldest vaccine for the protection of tuberculosis (TB) and for the treatment of bladder cancer at an early stage.

An earlier study by the researchers on mice models with type 1 diabetes has shown that type 1 diabetes can be cured by increasing the production of tumor necrosis factor (TNF). That study result shows successful restoration of immune response and insulin production in the mice models.

Currently, researchers are conducting Phase 1 clinical trial. Researchers used BCG vaccine to increase tumor necrosis factor (TNF) levels safely as direct dosing of TNF is toxic in humans. In this trial, three adult participants with type 1 diabetes have received two doses of BCG vaccine with four weeks gap between each shot. After five years, researchers observed signs of improvement in the A1c levels in those three patients. At that time, researchers gave a similar BCG vaccine to five more adult participants with type 1 diabetes. Recently they gave a similar dosage to 111 participants. All the trial participants are adults with long-standing type 1 diabetes with an average disease duration of 19 years.

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After a eight-year follow-up studies, the participants of the initial Phase 1 clinical trial are showing improvement in the insulin production and reduction in A1c or blood sugar levels.

  • More than ten percent drop at three years.
  • More than 18 percent drop at four years.
  • Reduction in HbA1c levels continued for four more years. The HbA1c levels have reached average levels of 6.65 percent (a close to normal HbA1c levels) by the end of eight years.
  • There are no hypoglycemia events.

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Researchers found that the BCG vaccine changes the immune system and changes the biochemical reactions taking place within a cell (cellular metabolism). The BCG vaccine causes a shift in the glucose metabolism process in the body of the type 1 diabetes patient. The vaccine makes lymphocytes cells in the white cells (or immunity cells) to eat more sugar or glucose for energy by drawing glucose from the blood (a metabolic process called aerobic glycolysis). The clinical trials show regeneration and restoration of insulin-producing beta cells in the pancreas (which were destroyed previously by the immunity) with the generic bacillus Calmette-Guerin (BCG) vaccine.

Now the trial participants are checking their blood sugar levels for less number of times. The trial participants are still under insulin but daily dosage requirement is one-third less. There are no adverse side effects in the trial participants with the BCG vaccine. BCG vaccine is considered to be a safe vaccine.

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This study validates the use of BCG vaccine in lowering A1c levels in adult patients with type 1 diabetes. The participants under the Phase 1 clinical trials are showing a long-term reversal of type 1 diabetes but this reversal should be replicated in a larger trial. Researchers are going to conduct the FDA-approved phase 2 trial with the BCG vaccine. They are also trying to shorten the period between BCG dosage and subsequent improvement in the insulin production by giving more BCG vaccine dosage to about 150 participants with long longstanding type 1 diabetes.

BCG vaccine cures and reverse type 1 diabetes and reduce HbA1c or blood sugar glucose levels.
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A report was presented at the 78th Scientific Sessions of the American Diabetes Association, Orlando. The principal investigator and senior author of the trial were Dr. Denise L. Faustman, MD, Ph.D., director, Massachusetts General Hospital and also an associate professor of Medicine, Harvard Medical School, Harvard University, Boston, Massachusetts, United States. The study findings were published June 21, 2018 in the npj Vaccines journal. Title of the article was "Long-term reduction in hyperglycemia in advanced type 1 diabetes: the value of induced aerobic glycolysis with BCG vaccinations." DOI: doi.org/10.1038/s41541-018-0062-8

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