January 27, 2023

N.Y.U. Langone Withdraws From Type 1 Diabetes Vaccine Trial in Adolescents – The New York Times

Researchers at N.Y.U. Langone Health have pulled out of a trial investigating the use of an old tuberculosis vaccine to treat children with Type 1 diabetes only months after they began enrolling participants on Long Island.

The vaccine, called Bacillus-Calmette-Guerin, or B.C.G., has generated intense interest among various patient advocacy groups, including those focused on Alzheimer’s disease and cancer, as well as diabetes. So…….

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Researchers at N.Y.U. Langone Health have pulled out of a trial investigating the use of an old tuberculosis vaccine to treat children with Type 1 diabetes only months after they began enrolling participants on Long Island.

The vaccine, called Bacillus-Calmette-Guerin, or B.C.G., has generated intense interest among various patient advocacy groups, including those focused on Alzheimer’s disease and cancer, as well as diabetes. Some recent research suggests that the vaccine, first administered in 1921, also may protect against Covid-19 and respiratory diseases because of its broad effects on the immune system.

A large trial of the vaccine’s effects on blood sugar in adults with Type 1 diabetes is nearing completion. Scientists had hoped to test the B.C.G. vaccines on children as well, since good management of Type 1 diabetes leads to fewer complications related to diabetes.

The lead investigators of the pediatric trial, who are at Massachusetts General Hospital in Boston, are proceeding with the study, but N.Y.U. Langone’s abrupt withdrawal could potentially jeopardize its viability if they are unable to collect data on the children at the N.Y.U. site.

A total of 150 children were to be included in the study, and the N.Y.U. team had already given the vaccine to at least 18 youngsters. They were to be followed for five years; each was to receive eight safety-check visits in the first year after their inoculations.

“Who’s monitoring our daughter medically now, and who’s monitoring the injection site?” said Kevin Miller of Smithtown, N.Y., whose 14-year-old daughter enrolled in the study last year.

“I’m sure there is something in the fine print of all the papers we signed that says they have a legal right to do this,” Mr. Miller added, “but I don’t necessarily know that means it’s right to leave kids like my daughter and others hung out to dry.”

N.Y.U. Langone officials said in a statement that an institutional review board, which approved the study in December 2020, decided to end participation after reviewing more research about the B.C.G. vaccine.

A statement said that the university “determined that withdrawal from the study will not affect the safety of enrolled participants,” and said that the children could continue to see N.Y.U. physicians for their usual diabetes care.

An earlier study by the scientists at Massachusetts General found that two doses of B……..

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