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Trials of Type 1 Diabetes Vaccines Bring Mixed Results
Date:6/28/2011

come protective T cells instead of being . . . attacking [T cells]," Raz said. The vaccine increased the number of T cells secreting cytokines, chemicals that kept the beta cells from being destroyed in an immune attack.

In addition, the beta cells continued to make and release insulin for up to two years after diagnosis. These promising results could lead the way toward preventing type 1 diabetes, Raz said.

Raz noted that the drug does not appear to cause harm to humans. "Around 500 people have been exposed to the drug, and the drug is very safe," he said.

DiaPep277 is now being tested in a phase 3 trial, the researchers said.

Dr. Stuart Weinerman, chief of the division of endocrinology at North Shore-LIJ Health System in New Hyde Park, N.Y., called the DiaPep277 vaccine "a novel, interesting approach to managing type 1 diabetes."

However, there are questions about what happens when you change the functioning of T cells, he said. "Will changing T cell function have adverse affects?" he asked. "Whenever you deal with autoimmunity that's the first thing you ask about -- are you affecting the ability to fight infections?"

A second study, which looked at whether combining glutamic acid decarboxylase (GAD) plus aluminum hydroxide to create an antigen could prevent the loss of insulin production in patients newly diagnosed with type 1 diabetes.

Unfortunately, while this approach appeared beneficial in mice, it did not work in humans, the investigators found.

They tested the antigen in one group and compared it to two other groups, including one made up of "controls," or untreated subjects. However, beta cell function in all three groups declined at similar rates.

"Although promising in animal models, so far, in human studies it failed to show an effect," lead researcher Dr. Jay S. Skyler, professor of medicine, pediatrics and psychology at the University of Miami Miller School of Medicine, said during the press
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