BCG Vaccinations for Type 1 Diabetes in Children

This trial explores whether two BCG vaccinations can improve the immune and metabolic health of children with newly diagnosed Type 1 diabetes. Participants will receive either the BCG vaccine (Bacillus Calmette-Guérin vaccine) or a placebo (a harmless, inactive substance) to compare effects. Children who have had Type 1 diabetes for more than 3 months but less than a year and are currently managing it with insulin might be suitable for this study. The goal is to determine if the BCG vaccine can ease diabetes management and potentially enhance long-term health outcomes. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot be on certain medications like high-dose aspirin, chronic antibiotics, or glucocorticoids. It also states that you should not start or change medications that affect glucose metabolism within 14 days before the trial.

Research has shown that the Bacillus Calmette-Guérin (BCG) vaccine is generally safe for people. This old vaccine, primarily used to protect against tuberculosis, has been administered to millions of children worldwide for nearly a century.

While researchers explore new uses for BCG, such as aiding in Type 1 diabetes, its safety in humans remains well-established. Most people tolerate it well, and serious side effects are rare. Common side effects are mild and may include soreness at the injection site or a slight fever.

Unlike the standard treatments for Type 1 Diabetes, which typically involve insulin therapy and continuous glucose monitoring, the Bacillus Calmette-Guérin (BCG) vaccine offers a novel approach by potentially modulating the immune system. Researchers are excited about BCG because it may alter immune responses in a way that protects insulin-producing cells, which are usually attacked in Type 1 Diabetes. This could lead to a more sustainable and less invasive treatment option, reducing the need for frequent insulin injections and offering a new path for disease management.

This trial will compare the effects of the Bacillus Calmette-Guérin (BCG) vaccine with a saline injection placebo in children with Type 1 diabetes. Research suggests that receiving the BCG vaccine more than once might help manage Type 1 diabetes. Early studies found that BCG could reduce certain harmful white blood cells that cause problems in diabetes. Additionally, a reported drop in HbA1c levels, which measure blood sugar control, occurred after BCG shots in adults with diabetes. While these results are encouraging, strong proof that BCG effectively treats Type 1 diabetes is still lacking. More research is needed to fully understand its effects.¹²⁶⁷⁸