Could There Be a Vaccine for Type 1 Diabetes?

This content originally appeared on Diatribe. It was reissued with permission.

by Andrew Briskin

In searching for new and innovative ways to treat type 1 diabetes, researchers are considering developing treatments that protect or improve the body’s ability to produce unique insulin. Learn about the basics of vaccines currently under development and how to potentially slow or stop the progression of type 1 diabetes.

For decades, type 1 diabetes treatment has focused primarily on treating conditions with insulin. However, in recent years, treatments targeting the immune system (immunotherapy) have gained increasing traction power with the possibility of delaying or preventing Type 1.

You may have heard of a new drug called Tzield (Teplizumab). This is the first and only treatment so far to delay the onset of type 1 diabetes for over two years. Another vaccine currently under investigation is Diamyd, which also has promising potential immunotherapy for type 1.

As a reminder, type 1 diabetes is a condition in which the body’s immune system attacks and destroys cells in the pancreas that produce insulin, known as beta cells. This occurs because of what is called an automatic antibody. Antibodies are part of the immune system. Their goal is to identify and neutralize bacteria and viruses. However, autoantibodies mistakenly target one or more of the body’s proteins that can damage tissue or organs. One autoantibody, usually found in people with type 1 diabetes, targets a type of protein known as GAD-65.

Destruction of beta cells progresses at different rates depending on the individual. However, by the time type 1 diabetes was usually diagnosed, approximately 80% of the beta cells were destroyed. This injury continues until the person is completely dependent on insulin injections.

But what if the vaccine could stop before this automated immune destruction occurs? Enter Diamyd Medical, a Swedish biotechnology company, and Diamyd, a unique approach to developing a type 1 vaccine.

How vaccines work

Because GAD-65 is found in beta cells in the pancreas, autoantibodies against GAD-65 recognize proteins and damaged beta cells.

“What we want to do is reprogram the immune system, especially GAD-65,” said Ulf Hannelius, CEO of Diamyd Medical. “The goal is to alter the proinflammatory autoimmune response to GAD-65 and distort it into an anti-inflammatory response.”

Diamyd researchers are currently using an approach injecting small amounts of GAD-65 protein into lymph nodes several times during their research (lymph nodes are small bean-shaped structures throughout the body).

Hope works to reduce and preserve attacks, instead of migrating into the pancreas, encountering beta cells of GAD-65, destroying beta cells.

Where we are today

Over the past 20 years, several disorders have been in the way of Type 1 vaccines, including a trial that was suspended in 2011, which failed to demonstrate the effectiveness of the vaccine. Since then, the company has made some changes Hannelius said, including how the vaccine is administered (now injected directly into the lymph nodes rather than under the skin). Another research trial was partially held in the US in 2021 and was lifted in 2022.

“We haven’t actually made any changes to the drugs or formulations, but we’re currently administering vaccines directly to the lymph nodes, where the immune response occurs, and it’s a much lower dose,” Hannelius said. “Even if the amount is small, there is a much stronger immune response compared to when injected (just under the skin).”

Additionally, the company is currently screening the presence of certain genes at high risk for type 1 diabetes. According to Hannelius, the gene was found in up to 40% of type 1 people, and this subgroup has responded particularly positively in clinical trials.

The data has been promising over the past few years. In 2021, the company announced the results of its Phase 2B trial, Diagnode-2. This study, which includes 109 study participants aged 12-24 years, showed that the vaccine improved glucose management (measured by range) in recently diagnosed study participants compared to the placebo group.

In 2022, Diamyd published the results of a safety survey of 14 people with promising results in people diagnosed with potential autoimmune diabetes in adults (LADA). Like Type 1, LADA is a type of autoimmune diabetes, but attacking beta cells takes time and usually diagnoses occur in adults.

Ongoing: Diamyd Clinical Trial

Diamyd is currently in the process of a new phase 3 trial called Diagnode-3 (currently adopted). The trial is scheduled to close in the second half of 2025, registering 330 participants in 60 locations around the world, including the US, Czech Republic, Estonia, Germany, Hungary, the Netherlands, Poland, Spain and Sweden.

Another trial, called Diaprecise, began in 2023 to assess the safety and feasibility of Diamyd in children aged 8-18 who carry the genes of type 1 diabetes and teenagers. The FDA has recently quickly followed the review process for this particular exam. This is a promising step forward with a type 1 diabetes vaccine for children. This exam is currently being adopted in Sweden. Here’s how this is involved:

In general, Diamyd represents another effort to find immunotherapy that may delay or prevent type 1 diabetes and may prevent future complications. Researchers continue to work towards new and innovative ways to treat type 1 diabetes, and diamide vaccines could ultimately be a treatment option to combat the immune response that leads to type 1 diabetes, unlike insulin.