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

 

A BCG Vaccine Can Help A Reversal Of Type 1 Diabetes

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Type 1 diabetes (T1D) is a chronic autoimmune disease affecting about 30,000 people every year in the United States. JDRF says about three million people were affected by the type 1 diabetes (T1D) in the United States.


A BCG vaccine can cure and reverse type 1 diabetes and can lower the HbA1c or blood sugar (glucose) levels.

An individual with type 1 diabetes is at an enhanced risk of heart diseases (such as heart attack and stroke) and hypoglycemia (a low blood sugar levels). An earlier study shows a one-third cut in the risk of heart disease with every ten percent drop in the A1c levels.



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A long-term clinical trial and a follow-up study was successful 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 an old vaccine for the protection of tuberculosis (TB) and for the treatment of early-stage bladder cancer.

An earlier study on the 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 shows a successful restoration of the immune response and insulin-secretion in the mice models.

Currently, researchers are conducting Phase 1 clinical trial. Researchers are using the BCG vaccine to increase the tumor necrosis factor (TNF) levels as a direct TNF is toxic to humans. In this trial, three adult participants with type 1 diabetes have received two doses of BCG vaccine with a four-week gap between each shot.


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After five years, researchers observed the signs of improvement in the A1c levels of the participants. At that time, researchers gave a similar dose of BCG vaccine to five more adult participants with type 1 diabetes. Recently they gave a similar dose to 111 participants. All the participants of the trial are adults with a long-standing type 1 diabetes with an average disease duration of 19 years.

After an eight-year follow-up study, the first participants of Phase 1 clinical trial are showing improvement in the insulin-secretion and reduction in the A1c or blood sugar (glucose) levels. The trial shows the following.


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  • More than ten percent of the drop in the A1C levels at three years.
  • More than 18 percent of the drop in the A1C levels at four years.
  • Reduction in the A1C levels was continued for four more years. The A1C levels have reached an average level of 6.65 percent (a close to normal A1C levels) at the end of eight years.
  • There are no hypoglycemia events.

Researchers found that the BCG vaccine can change the immune system and can change the biochemical reactions taking place within a cell (cellular metabolism). The BCG vaccine can cause a shift in the glucose metabolism in the patient with type 1 diabetes. The vaccine can force the lymphocytes (a subtype of white blood cell) to eat more sugar (glucose) for energy. The new lymphocytes will lower the blood sugar levels by drawing glucose from the blood (a metabolic process called aerobic glycolysis).


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The clinical trial shows the regeneration and restoration of insulin-secreting beta cells in the pancreas (which were destroyed previously by the immunity) with the generic Bacillus Calmette-Guerin (BCG) vaccine.

Now, the participants of the trial are checking the blood sugar levels fewer in number. The participants of the trial are still taking insulin but the daily dose of insulin was cut by one-third. There are no adverse side effects in the participants of the trial with the BCG vaccine. The BCG vaccine is considered to be a safe vaccine.

This study validates the use of BCG vaccine in lowering the A1c levels of adult patients with type 1 diabetes. The participants of Phase 1 clinical trials are showing a long-term reversal of type 1 diabetes. But the reversal of type 1 diabetes should be replicated in a larger clinical trial.


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Researchers are going to conduct the FDA-approved Phase 2 trial with the BCG vaccine. They are also trying to shorten the period between the administration of BCG and improvement in the insulin-secretion by giving more BCG vaccine to about 150 participants with long a long-standing type 1 diabetes.

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 was 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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