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Bcg Vaccine Diabetes

Second Tuberculosis Vaccine Treatment For Type 1 Diabetes Underway

Second Tuberculosis Vaccine Treatment For Type 1 Diabetes Underway

A clinical trial to investigate whether repeated injections of the tuberculosis vaccine bacille Calmette-Guérin holds promise… The researchers announced the start of their phase 2 trial at the American Diabetes Association (ADA) 75th Scientific Sessions in Boston. Study author Denise Faustman, MD, director of the immunobiology laboratory at Massachusetts General Hospital in Boston, added that, “BCG is showing so much promise in worldwide trials [for conditions such as multiple sclerosis].” The BCG vaccine works by increasing levels of tumor necrosis factor (TNF) in the body, Faustman said. In type 1 diabetes, higher TNF levels appear to reduce abnormal white blood cells responsible for the related autoimmunity, and stimulate production of protective regulatory T cells. The phase 1 trial of the vaccine lasted 20 weeks. The average time the study volunteers had diabetes was 15 years. They were randomly assigned to receive two injections of the vaccine or a placebo. The treatment was associated with temporary elimination of diabetes-causing T cells as well as a small, transient return of insulin secretion. The new randomized, double-blind trial will include 150 adults aged 18 to 60 years. Volunteers will receive two injections, of either the vaccine or a placebo, 2 weeks apart. Then they’ll be given a single injection annually for the next 4 years. This summer, she and her colleagues will begin enrolling patients ages 18 to 60 in a larger five-year trial. Participants will have low but detectable levels of insulin secretion from the pancreas. They’ll receive two injections, four weeks apart, of either BCG or placebo, and then annual injections for the next four years. Faustman said initially they’ll need to do blood tests every 2 weeks or so. Eventually, blood Continue reading >>

Human Study Re-ignites Debate Over Controversial Diabetes

Human Study Re-ignites Debate Over Controversial Diabetes "cure"

* TB vaccine seen attacking disease-caused autoimmunity * Long-term type 1 diabetes patients produce insulin again * Effect lasts for a week, further trials to boost dosing NEW YORK, Aug 8 (Reuters) - A controversial experimental cure for type 1 diabetes, using a tuberculosis vaccine invented a century ago, appears to temporarily vanquish the disease, according to a study in a handful of patients led by a scientist long criticized by her peers. There is no guarantee the results from this early-stage trial, published on Wednesday in the journal PLoS One, will stand up in larger studies, which are now under way. Other diabetes researchers criticized it for going beyond the evidence in its claims about what caused the observed effects. If the findings do hold up, however, they would mean that the generic bacillus Calmette-Guerin (BCG) vaccine, in use since 1921, can regenerate insulin-secreting cells in the pancreas, whose loss causes the disease. "We think we're seeing early evidence of effectiveness," said immunology researcher Denise Faustman of Massachusetts General Hospital, who led the trial. "This simple, inexpensive vaccine attacks the autoimmunity underlying type 1 diabetes." That autoimmunity, in which the immune system turns on the body's own cells rather than invaders, destroys insulin-producing "islet" cells in the pancreas. As a result, patients have to regularly inject themselves with insulin to control their blood sugar, or glucose. Also known as juvenile diabetes, the disease affects as many as 3 million Americans, estimates JDRF (formerly the Juvenile Diabetes Research Foundation). Another 30,000 people in the United States, half of them adults, are diagnosed every year with the disease, which has long been considered incurable. "We found that even low do Continue reading >>

How Bcg Vaccine Works To Stimulate The Reversal Of Type-1 Diabetes

How Bcg Vaccine Works To Stimulate The Reversal Of Type-1 Diabetes

Researchers from the Faustman Laboratory at Massachusetts General Hospital, who successfully carried out Phase I of bacillus Calmette-Guérin (BCG) human clinical trials, presented the interim results of their phase II research at the 77th Scientific Sessions of the American Diabetes Association on June 10. The researchers have previously found that proper BCG treatment could result in permanent reversal from the autoimmune disease. During the presentation, principal investigator Dr. Denise Faustman offered an explanation with regard to how the BCG potentially works to prevent and treat type-1 diabetes. How BCG Vaccine Works Against Type-1 Diabetes According to Dr. Faustman, the effectiveness of the BCG vaccine lies in how it encourages a permanent increase in regulatory genes that prevent an autoimmune response. Their findings show that the BCG vaccine targets rogue T-cells that mistakenly attack insulin secreting islets. When the attacks let up, the immune system gets a much need reboot to enable cells to properly function and Tregs, the immune system "brakes" which should have been able to stop rogue cells, would be able to function properly again and stop further attacks. "The vaccine actually resets your genes to restore normality," Dr. Faustman said. BCG Vaccine Human Clinical Trials Dr. Faustman's research team was the first to confirm positive results with using the BCG vaccine to target abnormal cells that cause autoimmune diseases. Specifically, mice with advanced type-1 diabetes fully recovered from the disease using the treatment. Findings from the Phase I trials, which concluded in 2012, show that the vaccine BCG may be capable of fully restoring balance in human genes to stimulate remission from Type-1 diabetes, but administration of the vaccine only happe Continue reading >>

Can A Tuberculosis Vaccine Combat Type 1?

Can A Tuberculosis Vaccine Combat Type 1?

Human trials show the vaccine might repair the pancreas in those who have long had Type 1. Sometimes, promising Type 1 diabetes treatments are developed from treatments for other conditions. If you have Type 1 diabetes, there’s good reason to be interested in what’s happening with the BCG vaccine, a treatment used to curb the spread of tuberculosis. BCG stands for “bacillus Calmette-Guerin,” a weakened strain of bacteria that has been used in humans for over 90 years, typically for the prevention of tuberculosis. In the US, we don’t routinely give the BCG vaccine because there’s a relatively low risk of contracting this lung disease. Around the world, however, infants are routinely immunized with this safe and well-tested drug. Although BCG therapy has had mixed results in treating Type 1 diabetes in past trials, more recent studies show promise, especially in people who have been living with the disease for some time. One of the things that BCG does is stimulate the production of a hormone called tumor necrosis factor (TNF). Studies conducted in our lab at Massachusetts General Hospital over a decade ago showed that temporarily elevating TNF helps to reverse Type 1 diabetes in mice, in part by stopping the autoimmune attack on the pancreas. This allows the pancreas to heal, regenerate, and begin to produce some insulin again. We were able to translate these findings into human clinical trials using the BCG vaccine. Our Phase I study showed that repeat BCG vaccination in people who had been living with Type 1 diabetes for an average of 15 years could kill the “bad” white blood cells that attack the pancreas, leading to early signs of pancreatic repair, accompanied with a temporary boost in insulin production. Following these positive results, a Phase II Continue reading >>

Get Information On Our Clinical Trials

Get Information On Our Clinical Trials

BCG Human Clinical Trials Program The Faustman Lab is conducting clinical trials in long-term type 1 diabetes through the BCG Human Clinical Trial Program. This program is testing Bacillus Calmette-Guérin (BCG), an inexpensive generic drug that temporarily elevates levels of TNF (a signaling protein involved in the body’s immune responses), to see if it will benefit patients living with type 1 diabetes by eliminating the disease-causing T cells that attack and destroy the insulin-secreting cells of the pancreas. Under the direction of Dr. Faustman and David Nathan, MD, director of the MGH Diabetes Center, a double-blind, placebo-controlled Phase I human clinical trial was conducted and demonstrated that BCG vaccination is not only safe in individuals with advanced type 1 diabetes, but may also be effective in reversing long-term disease. In the study, BCG was administered to adults who had been living with type 1 diabetes for an average of 15 years. Treatment helped eliminate the defective T cells that mistakenly attack and destroy the insulin-producing cells of the pancreas, also temporarily restoring the ability of the pancreas to produce small amounts of insulin. The results of the Phase I study were published in 2012. Major Findings from the Phase I Trial The major findings from the Phase I study were: • The BCG vaccine with multi-dosing was safe in advanced type 1 diabetes. • Although the drug was given in relatively small doses, we saw targeted death of the “bad” T cells that attack the insulin-secreting islets, an early sign that BCG has the potential to stop the autoimmune attack and successfully reverse disease. • In people living with diabetes for an average of 15 years, there was a transient increase in/restoration of pancreatic insulin secretion Continue reading >>

Can Tb Vaccine Stop Type 1 Diabetes?

Can Tb Vaccine Stop Type 1 Diabetes?

Maybe. A small clinical study found "proof of principle" that the BCG tuberculosis vaccine might help adults with long-standing type 1 diabetes. Over a decade ago, Denise Faustman, MD, PhD, and colleagues at Massachusetts General Hospital and Harvard Medical School showed that the BCG vaccine worked in diabetic mice. By stimulating positive immune responses, the vaccine stopped the haywire immune responses that cause diabetes. Once this happened, the animals' insulin-making cells regenerated. Other researchers duplicated the mouse studies. This led to "a lot of happy mice," Faustman says. But translating the findings to humans hasn't been easy. For starters, it required learning a lot more about the immune system and a lot more about type 1 diabetes. It didn't look promising. A 1999 study found no effect of BCG vaccination in kids newly diagnosed with type 1 diabetes. "When we started, there wasn't too much enthusiasm about trying to reverse diabetes in people 15 to 20 years out with this disease," Faustman tells WebMD. She persisted. "Surprisingly, our data was so good we got a signoff on doing a safety trial from the FDA," she says. "Even more surprising was that in this safety study, at a very low dose and after only two BCG vaccinations, we started seeing indications that this vaccine is doing the same thing in people as it does in the mouse." Hopeful Signs but No Lasting Effect In the study, six insulin-dependent adults with type 1 diabetes received either two doses of BCG or two fake vaccinations. The two groups were compared to one another, to 57 diabetes patients, and to 16 people without diabetes. In the three patients who received the vaccine: "Bad" anti-insulin T cells began dying off. New "good" regulatory T cells increased. There were signs of new, albeit t Continue reading >>

J Ayub Med Coll Abbottabad 2017;29(1)

J Ayub Med Coll Abbottabad 2017;29(1)

1 EDITORIAL BCG VACCINE - AN INNOVATION FOR DIABETES TREATMENT IN PAKISTAN? Zohair Lilani, Afrinah Ahmed, Rabbia Tazeem, Erum Naeem Karachi Medical and Dental College, Karachi-Pakistan Pakistan is a third world country with very small health budget and a diabetes prevalence of about 6.9% among adults, accounting for over 86,000 deaths. If phase 2 trials testing the ability of BCG to reverse type 1 Diabetes become successful in remission of insulin from pancreas this would be very useful to treat diabetes in Pakistan as BCG is readily available, less expensive, has less storage problems, less side effects and doesn't require skilful person to administer. Keywords: Diabetes; BCG; Pakistan J Ayub Med Coll Abbottabad 2017;29(1): According to International Diabetes Federation's published statistics about diabetes in Pakistan in 2015, Pakistan has a diabetes prevalence of about 6.9% among adults, accounting for over 86,000 deaths.1 IDDM (also known as diabetes type 1) is an autoimmune disorder in which body's own T cells react with beta cells of pancreas resulting in depletion of insulin which is responsible for glucose uptake in the cells.2 Diabetes also forms a major risk factor of MI and increases mortality due to masking of alarming symptoms. It also leads to serious irreversible complications like neuropathy, retinopathy etc. According to Phase 1 randomized control trials, which was published in the August 8 20123, the BCG (Bacillus Calmette- Guérin) vaccine induces the production of TNF which eliminates auto reactive "bad" T cells resulting in remission of insulin production from the pancreas. Another study in July 1 20014, also demonstrated reversal of type 1 diabetes by restoration of endogenous beta cell function by inducing TNF alpha through BCG vaccine. On the o Continue reading >>

Practical Cure Project Update: Bcg

Practical Cure Project Update: Bcg

Summary: The BCG Human Clinical Trial Program is one of twelve T1D Practical Cure projects currently in human trials. A phase I trial was completed in 2012 and confirmed the safety of using BCG in patients with established T1D. An eight-year follow-up report on phase I participants is expected by the end of 2017. A phase II 150 person trial hoping to demonstrate the effectiveness of BCG in reversing T1D in established adults is currently recruiting. There are 25 more patient slots available for type 1 diabetics interested in participating in the trial. This is the second in a series of reports detailing individual research projects currently in human trials with the potential to deliver a Practical Cure. The twelve Practical Cure projects that will be profiled were identified and summarized in the 2016 State of the Cure for Type 1 Diabetes, which was published during the first week of January 2017 (Click here to view). This report focuses on the BCG Human Clinical Trial Program at Massachusetts General Hospital and features an interview with the lead researcher Dr. Denise Faustman. The program is testing BCG (bacillus calmette-guérin), a drug currently used as a vaccine for tuberculosis, as a possible cure or permanent reversal for established type 1 diabetes. BCG is unique in that it is an inexpensive generic drug which, if approved, would be a cost-effective treatment for type 1. The trial is funded entirely by private philanthropic donations and is not supported by any for-profit research efforts or JDRF. BCG Background Faustman’s hypothesis is that the administration of BCG can stop the autoimmune attack in T1D and enable the restoration of near normal HbA1c values in part from beta cell regeneration. The rationale for why this works, according to Faustman, is ba Continue reading >>

Massachusetts General Hospital Launches Phase Ii Trial Of Bcg Vaccine To Reverse Type 1 Diabetes

Massachusetts General Hospital Launches Phase Ii Trial Of Bcg Vaccine To Reverse Type 1 Diabetes

A phase II clinical trial testing the ability of the generic vaccine bacillus Calmette-Guérin (BCG) to reverse advanced type 1 diabetes has received approval from the U.S. Food and Drug Administration (FDA). The approval of this trial, which will shortly begin enrolling qualified patients, was announced today at the 75th Scientific Sessions of the American Diabetes Association (ADA) by Denise Faustman, MD, PhD, director of the Massachusetts General Hospital (MGH) Immunobiology Laboratory and principal investigator of the study. The five-year trial will investigate whether repeat BCG vaccination can clinically improve type 1 diabetes in adults between 18 and 60 years of age who have small but still detectable levels of insulin secretion from the pancreas. Faustman's research team was the first group to document reversal of advanced type 1 diabetes in mice and subsequently completed a successful phase I human clinical trial of BCG vaccination. She announced the FDA approval to launch the phase II trial during her ADA presentation, "Low Levels of C-Peptide Have Clinical Significance for Established Type 1 Diabetes." "We have learned a lot since the early studies in mice - not just about how BCG works but also about its potential therapeutic benefits, similar to what are being seen in trials against other autoimmune diseases," says Faustman. "We are so grateful to all of the donors, large and small, who have made this trial possible - especially the Iacocca Foundation, which has believed in us and has been a supporter since our early days. Our goal is to complete enrollment and also to raise the remaining funds needed for the trial by the end of this year." A generic drug with over 90 years of clinical use and safety data, BCG is currently approved by the FDA for vaccinati Continue reading >>

Bcg Vaccine - Can It Reverse Type 1 Diabetes Mellitus?

Bcg Vaccine - Can It Reverse Type 1 Diabetes Mellitus?

Type 1 diabetes is an autoimmune disease characterized by the destruction of pancreatic islet cells , which are critical to glucose metabolism by producing insulin,by autoreactive T cells. These lymphocytes mistakenly attack pancreatic islet cells as if they were a foreign body, like a viral or bacterial infection. In addition, regulatory T-cells (which are often called Tregs) modulate the immune system and would generally reduce the effect of an autoimmune attack. Tregs act like brakes that normally prevent the mistaken attacks, like on the pancreatic islet cells, without affecting the whole immune system. A branch of diabetes research has suggested that Tregs could be the key to treating type 1 diabetes. Once the pancreatic islet cells are damaged, they no longer produce hormones, especially insulin , that help regulate the levels of blood glucose. Without insulin, the blood glucose levels increase rapidly leading to long-term damage to eyesight, kidneys, limbs, heart and other organs. In fact, type 1 diabetes can be deadly if the uncontrolled blood sugar leads to a life-threatening condition called diabetic ketoacidosis . Without regular insulin injections, a patient has little chance of living beyond a short period of time, and even then it could be a horrifically painful demise. It is not known what causes this autoimmune disease, although there is strong evidence that genetics is the most important factor. However, other things may be implicated, like vaccine-preventable diseases , which could be important co-factors in the development of the disease. Just to be clear, vaccines are not linked to type 1 diabetes . Currently, there are no known cures for type 1 diabetes. The only treatment for the disease are regular injections of human insulin, manufactured from g Continue reading >>

Repeat Bcg Vaccinations For The Treatment Of Established Type 1 Diabetes

Repeat Bcg Vaccinations For The Treatment Of Established Type 1 Diabetes

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. Published Phase I data on repeat BCG vaccinations in long term 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. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained. Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas. 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 Established Type 1 Diabetes Study Start Date : June 2015 Estimated Primary Completion Date : July 2020 Estimated Study Completion Date : July 2023 Resource links provided by the National Library of Medicine U.S. FDA Resources Arm Intervention/treatment Experimental: Bacillus Calmette-Guérin 2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years Biological: Bacillus Calmette-Guérin 2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years Placebo Comparator: Saline Continue reading >>

Bcg Vaccine Could Restore Proper Immune Response In Type 1 Diabetes

Bcg Vaccine Could Restore Proper Immune Response In Type 1 Diabetes

The results of a new clinical trial testing a type 1 diabetes vaccine have been presented at the 75th Scientific Sessions of the American Diabetes Association. The genetic vaccine bacillus Calmette-Guerin (BCG) has been shown to reverse advanced type 1 diabetes in mice, and could help to restore proper immune response to insulin-producing beta cells. The findings of this FDA-approved clinical trial were presented by principal investigator Dr Denise Faustman, PhD, director of the Massachusetts General Hospital Immunobiology Laboratory. The BCG vaccine is based on a harmless strain of bacteria related to one that causes tuberculosis. It is also approved by the FDA for treatment of bladder cancer. Faustman explained the BCG could induce a permanent gene expression that restores regulatory T cells (Tregs), helping to prevent the immune system attack which characterises type 1 diabetes. "BCG is interesting because it brings into play so many areas of immunology that we as a community have been looking at for decades, including Tregs and the hygiene hypothesis," said Faustman. "Repeat BCG vaccination appears to permanently turn on signature Treg genes, and the vaccine's beneficial effect on host immune response recapitulates decades of human co-evolution with myocbacteria, a relationship that has been lost with modern eating and living habits." Researchers worldwide have been examining the benefits of Tregs, but Faustman said that existing therapies have struggled to achieve long-term results. However, with BCG able to restore Tregs, this provides a clearer picture as to how vaccination works to reset the immune system within type 1 diabetes. Faustman's team was the first to document type 1 diabetes reversal in mice and in a subsequent phase I trial demonstrated successful hu Continue reading >>

Effect Of Bacillus Calmette-guerin Vaccination On New-onset Type 1 Diabetes. A Randomized Clinical Study.

Effect Of Bacillus Calmette-guerin Vaccination On New-onset Type 1 Diabetes. A Randomized Clinical Study.

OBJECTIVE: We undertook this study to test whether Bacillus Calmette-Guerin (BCG) vaccine preserves beta-cell function and increases the remission rate in children with new-onset type 1 diabetes. RESEARCH DESIGN AND METHODS: This was a randomized double-blind placebo-controlled trial offered to children referred to the Barbara Davis Center for Childhood Diabetes or the Baystate Medical Center with a diagnosis of new-onset type 1 diabetes. There were 94 children aged 5-18 years who received either BCG or saline intradermally within 4 months of onset of symptoms and who were then evaluated at 3-month intervals for 2 years. The primary end point was remission, defined as insulin independence for 4 weeks. Secondary end points were C-peptide levels (fasting and in response to a mixed meal challenge), insulin dose, and HbA1c. RESULTS: Of the patients, 47 were randomized to each arm; 7 in the placebo group and 9 in the BCG group did not complete 1 year of the study and are not included in the analysis. One patient from each group achieved remission. Fasting and stimulated C-peptide levels did not differ by treatment arm but declined in both groups and were lower initially and during the entire 2-year period in younger children. Insulin requirements and HbA1c levels did not differ in the two groups. CONCLUSIONS: Vaccination with BCG at the time of onset of type 1 diabetes does not increase the remission rate or preserve beta-cell function. OBJECTIVE: The purpose of this study was to compare measurements of glucose obtained via iontophoretic extraction with the GlucoWatch automatic glucose biographer (Cygnus, Inc., Redwood City, CA) with capillary blood glucose values that were determined 1) in a controlled outpatient clinic setting and 2) in a home setting. RESEARCH DESIGN AND Continue reading >>

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