A brake for diabetes
Type I diabetes vaccine has passed the second phase of clinical trials
Svetlana Maslova, Hi-tech+
The second phase of clinical trials has shown important results of testing a vaccine against type I diabetes mellitus in people with a newly diagnosed diagnosis. Patients managed to slow down the progression of the disease by preserving a key function – the independent production of insulin.
In type I diabetes, the insulin-producing cells are destroyed and can no longer regulate blood sugar levels. For this reason, patients are forced to inject insulin for life. The destruction is due to an error of the immune system, which targets against insulin-producing cells. Swedish scientists from Linkoping University decided to find out whether it is possible to stop the attack of the immune system with injections of a certain protein.
Article by Ludvigsson et al. Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial published in the journal Diabetes Care – VM.
The team began working with the enzyme glutamate decarboxylase (GAD65), against which the immune system often produces antibodies against the background of type I diabetes. They hoped to make the immune response more tolerant to stop damage to insulin-producing cells.
Previous studies have shown that even very small production of insulin in the body is beneficial to the patient's health. Such people are less likely to develop hypoglycemia and ketoacidosis – life-threatening complications of diabetes, scientists explain, so the main goal when creating a vaccine was precisely to preserve this function.
The second phase of the study involved 109 volunteers from 12 to 24 years old who had been diagnosed during the previous six months. Scientists knew that genetic factors play an important role in patients' response to treatment, so they considered several variants of human leukocyte antigen genes, or tissue compatibility systems (Human Leukocyte Antigens, HLA,), which are associated with an increased risk of type I diabetes mellitus. For example, with the HLA-DR3-DQ2 variant, patients' bodies often form antibodies against GAD65 at an early stage of the disease.
About half of the test participants had the HLA-DR3-DQ2 variant. All volunteers were injected with recombinant GAD65 conjugated with aluminum hydroxide (GAD-alum) into the lymph nodes. Before therapy and 15 months after injection, scientists assessed the body's natural insulin production.
In the subgroup with HLA-DR3-DQ2 genes, 15 months after injection, the ability to produce insulin was more than 50% better preserved compared to the subgroup receiving placebo. The volunteers without this genetic variant had no significant effect from treatment.
"Treatment with GAD65 seems to be a simple, safe and promising way to maintain insulin production in about half of patients with type I diabetes," said first author Johnny Ludvigsson. "We hope that further research will lead to the creation of a drug that can stop the progression of the disease."
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