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Type 1 Diabetes Vaccine Trial

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 >>

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 >>

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 >>

The Vaccine For Type-1 Diabetes Is Moving Forward

The Vaccine For Type-1 Diabetes Is Moving Forward

TIME Health For more, visit TIME Health. A promising vaccine that has the potential to reverse the symptoms of type I diabetes—an autoimmune disease often diagnosed in childhood—is heading on to a phase II trial, which will test the vaccine on humans with the chronic disease. The vaccine, called bacillus Calmette-Guérin (BCG) has succeed in reversing type 1 diabetes in a trial among mice and in a phase I trial in 103 humans. The new trial, which the researchers announced on Sunday at the Scientific Sessions of the American Diabetes Association, will last for five years and will test the effect of the vaccine on people with type 1 diabetes among adults between ages 18 to 60. The vaccine may be able to improve the disease in people who have small but detectable levels of insulin coming from their pancreas. Lead researcher Dr. Denise Faustman, director of immunobiology at Massachusetts General Hospital (MGH), estimates that about one million people with type 1 diabetes still produce some insulin. BCG is already FDA-approved as a vaccine for tuberculosis and as a bladder cancer treatment. Researchers have shown that the vaccine can eliminates problematic white blood cells that lead to type 1 diabetes by destroying the beta cells that make and release insulin into the blood. Previously, the study authors showed they were able to temporarily eliminate the abnormal white blood cells and provide a small return of insulin. The new trial will provide more frequent doses of the vaccine over a five year periods in 150 adults with the disease. The researchers hope that the vaccine will produce better blood sugar control and could be used to treat advanced disease. “Type 1 diabetics are a pretty skeptical audience,” says Faustman. “There’s been a lot of disappointment [f Continue reading >>

Type 1 Diabetes Vaccine Moving To Next Trial

Type 1 Diabetes Vaccine Moving To Next Trial

Type 1 Diabetes Vaccine Moving To Next Trial Type 1 Diabetes Vaccine Moving to Next Trial Science is taking steps toward reversing type 1 diabetes. Good news: a vaccine that can potentially reverse type 1 diabetes is moving on to the next phase of clinical trials. The vaccine is called bacillus Calmette-Gurin (BCG). It has been used for nearly a century to prevent tuberculosis, and more recently has treated bladder cancer. In a previous trial, BCG succeeded in reversing type 1 diabetes in mice and in 103 humans. This upcoming phase II trial will follow the effect of the vaccine on people who have advanced type 1 diabetes for five years. The participants include 150 adults ages 18 to 60 who still produce small but traceable amounts of insulin in their pancreas. The lead researcher of the trial, Dr. Denise Faustman of the Massachusetts General Hospital in Boston, estimates that about one million people with type 1 diabetes still produce traces of insulin. BCG has been able to eliminate abnormal white blood cells that spark type 1 diabetes. These white blood cells destroy pancreatic beta cells that make and release insulin into the blood. With these white blood cells in check, the hope is that greater insulin production will resume. In past trials, the researchers have been able to temporarily oust the problematic white blood cells, resulting in a small increase in the amount of insulin produced. Each participant will receive frequent doses of the vaccine over the five years, and part of the trial will study how large a dose is needed to make the vaccine effective. In the phase I (preliminary) trial we demonstrated a statistically significant response to BCG, but our goal in (this trial) is to create a lasting therapeutic response, Dr. Faustman said in a statement. We wil Continue reading >>

Fda Approves Mid-stage Trial Of Vaccine To Reverse Type 1 Diabetes

Fda Approves Mid-stage Trial Of Vaccine To Reverse Type 1 Diabetes

FDA approves mid-stage trial of vaccine to reverse type 1 diabetes (Reuters Health) - Diabetes researchers are hoping that an almost century-old vaccine for preventing tuberculosis may also reverse type 1 diabetes. The FDA has approved a mid-stage trial to test the vaccine, called bacillus Calmette-Guerin (BCG), in 150 adults with advanced cases of the disease. The approval was announced Sunday at the 75th Scientific Sessions of the American Diabetes Association by Dr. Denise Faustman, director of the Massachusetts General Hospital Immunobiology Laboratory in Boston and principal investigator of the study. According to the American Diabetes Association, 5 percent of people with diabetes - or roughly three million individuals - have type 1, in which the immune system attacks and destroys insulin-producing beta cells in the pancreas. Faustman told Reuters Health that the BCG vaccine temporarily raises levels of a substance called tumor necrosis factor, or TNF and the higher TNF levels can eliminate the damaging T cells in the blood of individuals with type 1 diabetes. In a small preliminary trial, Faustmans team found that two BCG injections given four weeks apart temporarily eliminated diabetes-causing T cells. Patients also showed evidence of small, temporary return of insulin secretion. 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. Theyll receive two injections, four weeks apart, of either BCG or placebo, and then annual injections for the next four years. If this trial is successful, the next step would be an even larger study in a greater number of patients. In the phase I (preliminary) trial we demonstrated a statis Continue reading >>

Fact Check: Finnish Researchers Set To Start Type 1 Diabetes Vaccine Trials?

Fact Check: Finnish Researchers Set To Start Type 1 Diabetes Vaccine Trials?

Finnish Researchers Set to Start Type 1 Diabetes Vaccine Trials? Scientists at Finnish universities are targeting a strand of viruses linked to Type 1 diabetes, and human trials for a vaccine will begin in 2018. In July 2017, it was announced that Finnish researchers would begin human trials of a Type 1 diabetes vaccine in 2018. On 19 July 2017, the Finnish news web site Yle reported that a group of Finnish researchers had developed a vaccine for Type 1 diabetes, and that human trials were set to begin in 2018: A vaccine for type 1 diabetes developed by Finnish researchers will be tested on mainly Finnish human subjects in late 2018, researchers announced on Tuesday.The scientists first found that the prototype works effectively and safely on mice, and now saythat the vaccine could be in mainstream use within eight years if the coming rounds of tests prove successful. One skeptical reader asked us to check out the story. Yle is Finlands public broadcasting corporation (akin to NPR or the BBC). T he names of the lead researchers and their universities are real, the announcement of vaccine trials is real, and the story is true. On 18 July 2017, the University of Tampere in Finland announced that Professor of Virology Heikki Hyty and his team of researchers had identified a particular strand of enteroviruses (viruses transmitted through the intestines) linked to Type 1 diabetes, and developed a vaccine against them. Already now it is known that the vaccine is effective and safe on mice, Hyty said. The developing process has now taken a significant leap forward as the next phase is to study the vaccine in humans. In the first clinical phase, the vaccine will be studied in a small group of adults to ensure the safety of the vaccine. In the second phase, the vaccine will be Continue reading >>

Type 1 Diabetes Vaccine Moving To Human Trials In Finland

Type 1 Diabetes Vaccine Moving To Human Trials In Finland

It has long been hypothesized that viral infections play a significant role in the development of type 1 diabetes. Researchers in Finland have been investigating this connection for over 25 years and now believe they have targeted the particular virus group that can trigger the disease. After developing a prototype vaccine the team is now moving to human clinical trials in 2018. Though not as common as type 2 diabetes, type 1 diabetes it still affects millions of people worldwide. The disease generally begins in childhood and an estimated 80,000 new cases are diagnosed worldwide every year. Type 1 diabetes occurs when the immune system destroys insulin-producing beta cells in the pancreas. Recent research suggests that enteroviruses could play a strong role in the onset of type 1 diabetes, with several studies showing that the presence of an enteroviral infection significantly increases the chance of a person developing the disease. The causal relationship between an enteroviral infection and type 1 diabetes is still unknown, but one study suggests it could act as "a critical trigger to push an already dysfunctional metabolic equilibrium over the brink." A research group at the University of Tampere initially looked at the more than 100 different enterovirus types found in humans. After pinpointing six specific viral strains that could be associated with type 1 diabetes they ultimately identified the one type that held the biggest risk. A prototype vaccine was then produced and successfully tested on animals. "Already now it is known that the vaccine is effective and safe on mice," says Heikki Hyöty, Professor of Virology and lead on the research. "The developing process has now taken a significant leap forward as the next phase is to study the vaccine in humans." Thre Continue reading >>

A Vaccine For Type 1 Diabetes Is Headed For Human Trials In 2018

A Vaccine For Type 1 Diabetes Is Headed For Human Trials In 2018

After 25 years of dedicated research, a potential vaccine for Type 1 Diabetes developed in Finland is headed for human clinical trials. Type 1 Diabetes By the year 2050, it’s anticipated that in the U.S. alone, 5 million people will be diagnosed with Type 1 Diabetes (T1D). This autoimmune disease, which affects children and adults, is currently unable to be prevented or cured. In order to manage T1D, people with the condition must constantly monitor their blood glucose levels, and manage those levels through insulin injection, activity, and diet in order to avoid life-threatening complications. It has been suggested, for quite some time now, that T1D could be related to viral infection, which has lead some to propose the possibility of creating a vaccine for the disease. In Finland, researchers have been exploring this connection and potential vaccine for approximately 25 years. After such a laborious scientific journey, they believe they’ve found the viral group that can trigger T1D. The hard work seems to have paid off — as the team has created a prototype vaccine which will move into human clinical trials by 2018. The Future of T1D While it’s unlikely that the vaccine would become an immediate cure-all T1D, if the trials prove successful, it will dramatically shift the future of the disease. Up until this point, patients with T1D have been required to vigilantly self-manage. Complications of the disease, which can result when it goes undiagnosed or is ineffectively managed, can range from heart attack to stroke, amputation, kidney failure, and even blindness. The threat of these complications constantly hangs over the heads of those with T1D. Unfortunately, as the team notes, this vaccine would not be a cure for T1D, but if it proves successful in preventing Continue reading >>

Vaccine Therapies For The Prevention Of Type 1 Diabetes Mellitus.

Vaccine Therapies For The Prevention Of Type 1 Diabetes Mellitus.

Vaccine therapies for the prevention of type 1 diabetes mellitus. Autoimmunity Research Unit, The Canberra Hospital, Canberra, Australian Capital Territory, Australia and John Curtin School of Medical Research, Australian National University, Canberra, Australian Capital Territory, Australia. [email protected] Type 1 diabetes mellitus results from immune-mediated destruction of pancreatic beta-cells, leading to loss of insulin production. Strategies to prevent or reverse diabetes development include beta-cell protection, regeneration, or replacement. Recent advances in our understanding of the autoimmune process leading to diabetes has generated interest in the potential use of immunomodulatory agents that may collectively be termed vaccines, to prevent type 1 diabetes. Vaccines may work in various ways, including changing the immune response from a destructive (e.g. Th1) to a more benign (e.g. Th2) response, inducing antigen-specific regulatory T cells, deleting autoreactive T cells, or preventing immune cell interaction. To date, most diabetes vaccine development has been in animal models, with relatively few human trials having been completed. A major finding of animal models such as the non-obese diabetic (NOD) mouse is that they are extremely sensitive to diabetes protection, such that many interventions that protect mice are not successful in humans. This is particularly evident for human insulin tolerance studies, including the Diabetes Prevention Trial-1, where no human protection was seen from insulin despite positive NOD results. Further challenges are posed by the need to translate protective vaccine doses in mice to effective human doses. Despite such problems, some promising human vaccine data are beginning to emerge. Recent pilot studies have s Continue reading >>

Dr. Faustman’s Type 1 Reversal Trial Seeks More Participants

Dr. Faustman’s Type 1 Reversal Trial Seeks More Participants

Denise Faustman, MD, PhD, is the Director of the Immunobiology Lab at Massachusetts General Hospital and an Associate Professor of Medicine at Harvard Medical School. She was interviewed by Diabetes Daily about 9 years ago when she was about to begin human clinical trials based on the results from her successful mice-curing BCG vaccine. Mice are certainly cured from type 1 diabetes a lot these days, but in clinical trials, they are often given type 1 diabetes through an interventional chemical administration. It is notable that Dr. Faustman cured mice who had naturally occurring type 1 diabetes which is rooted in the autoimmune attack on the insulin-making beta cells. The BCG vaccine, or Bacillus Calmette-Guerin vaccine, is about 100 years old and used around the world, though no longer in the United States, for the prevention of tuberculosis. It is being studied in various labs around the world due to its ability to spark the production of tumor necrosis factor, a hormone that kills disease-causing autoimmune cells. Without these bad autoimmune cells the pancreas’s beta-cell function may be theoretically restored. Dr. Faustman spoke frankly with me over the phone. She explained how in global studies, the effects of this treatment is being shown to occur in 2-3 years after treatment versus a few weeks. For example, promising results have been shown involving the BCG vaccine and another autoimmune disease–multiple sclerosis. Phase II of Trial in Process Dr. Faustman’s lab reported positive results from their Phase I study in 2012 and are now in Phase II of that study trying to repeat the tests with a larger number of participants. Phase II should be completed in 2023. Dr. Faustman said that the endpoint of this trial is unique because it is going to focus on the lo Continue reading >>

Endocrine Society Reading Room | Type 1 Diabetes Vaccines Move Through Research Pipelines | Medpage Today

Endocrine Society Reading Room | Type 1 Diabetes Vaccines Move Through Research Pipelines | Medpage Today

Type 1 Diabetes Vaccines Move Through Research Pipelines Human trials for separate vaccines in U.S. and Europe, but still not ready for prime time This Reading Room is a collaboration between MedPage Today and: Justin B. Echouffo Tcheugui MD, PhD Brigham and Women's Hospital Boston, MA Type 1 diabetes is considered an autoimmune disease. The worldwide increase in its incidence has sparked research efforts geared toward developing interventions to prevent or halt the condition. Indeed, two separate vaccines for type 1 diabetes are being explored in human clinical trials. The two vaccinal options, including bacillus Calmette-Guerin (BCG) and an unnamed vaccine, are being tested in the US and Finland, respectively. At this stage, their therapeutic potential remains only putative. Although the BCG may possess curative and preventive potentials, its assessment has so far focused on its ability to reverse type 1 diabetes, including among those with long-standing disease. BCG acts by increasing the levels of the tumor necrosis factor (TNF) protein, thus reducing the number of autoreactive T cells and increasing the so called good T cells or Tregs. The latter cells would then reset the immune system and thereby stopping beta cells destruction with a restoration of insulin production. The ongoing human trial of BCG is testing against placebo, the effect of two injections four weeks apart during the first year followed by one injection each year for the next four years. The unnamed vaccine aims at preventing type 1 diabetes. After being found to be effective and safe in mice, it is currently being tested in humans. Like the BCG, it also affects autoimmunity, but targets the coxsackievirus B1 (CVB1), an enterovirus linked to an increased risk of autoimmunity and known to destroys Continue reading >>

Research Spotlight A Vaccine For Type 1 Diabetes

Research Spotlight A Vaccine For Type 1 Diabetes

Research spotlight a vaccine for Type 1 diabetes Research spotlight a vaccine for Type 1 diabetes Type 1 diabetes occurs when the bodys immune system, which normally protects against infection and illness, attacks cells in the pancreas that make insulin the hormone that regulates levels of glucose in the blood. Current treatments for Type 1 diabetes focus on replacing lost insulin, and provide an effective way to minimise life-threatening complications. However, they involve a lifetime of insulin injections or an insulin pump and don't treat the underlying 'autoimmune' attack. Research has shown that immunosuppressant drugs (similar to those used after an organ transplant) weaken the autoimmune attack that causes Type 1 diabetes, helping to prevent the destruction of insulin-producing cells and leading to short-term improvements in blood glucose control. Unfortunately, blanket suppression of the immune system as a whole also increases our vulnerability to infections, cancer and other potentially harmful side effects. In order to selectively target the 'bad' parts of the immune system, while leaving vital immune defences intact, scientists are working to understand Type 1 autoimmunity in great detail and are already testing more specific treatments. Scientists are searching for highly effective ways to control the immune system, known as 'immunotherapies'. If effective, these immunotherapies could be used to change the behaviour of the immune system and protect against Type 1 diabetes like a vaccine. This research could lead to ways to prevent Type 1 diabetes from developing in those at risk, and slow the progression of Type 1 diabetes in those already diagnosed. Diabetes UK is funding research to improve our understanding of the immune attack in Type 1 diabetes and fin Continue reading >>

A Vaccine For Type 1 Diabetes Begins Human Trials In 2018

A Vaccine For Type 1 Diabetes Begins Human Trials In 2018

A prototype vaccine, decades in the making, that could prevent type 1 diabetes in children is ready to start clinical trials in 2018. It's not a cure, and it won't eliminate the disease altogether, but the vaccine is expected to provide immunity against a virus that has been found to trigger the body's defences into attacking itself, potentially reducing the number of new diabetes cases each year. Over two decades of research led by the University of Tampere in Finland has already provided solid evidence linking a type of virus called coxsackievirus B1 with an autoimmune reaction that causes the body to destroy cells in its own pancreas. The type 1 form of diabetes – not to be confused with the more prevalent type 2 variety that tends to affect individuals later in life – is a decreased ability to produce the insulin used by the body's cells to absorb glucose out of the blood. This loss of insulin is the result of pancreatic tissue called beta cells being destroyed by the body's own immune system, often within the first few years of life. It's something of a mystery as to why the body identifies beta cells as foreign, though there could be a genetic link producing variations of human leukocyte markers, which act as the cell's 'ID tags'. No doubt it's complex, and there are numerous ways this process can be triggered. One example established by virologist Heikki Hyöty from the University of Tampere is an infection by a type of enterovirus. Enteroviruses are nasty pieces of work; you might be most familiar with polio, but they can also cause hand, foot and mouth disease, meningitis and myocarditis. There has been suspicion of a link between this group of pathogens and diabetes for a number of years, but it took time to nail down the prime suspects. In 2014, Hyöty an 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 >>

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