FDA approves vaccine trial for type 1 diabetes
The FDA has approved a trial for a vaccine for type 1 diabetes that will launch this summer. Doctor Denise Faustman of Massachusetts General Hospital has been studying BCG for reversing type 1 diabetes.
FDA approval for phase II clinical testing was announced at the 75th Scientific Sessions of the American Diabetes Association (ADA). The plan is to begin studying BCG bacillus CalmetteGuérin this summer in human trials. The study will include qualified patients 18 to 60 years of age whose pancreas still secrete detectable levels of insulin.
BCG vaccine was successful for temporary reversals of type 1 diabetes in a Phase I trial, which was published in 2012. The first testing was performed on mice; then the vaccine was demonstrated to also temporarily reverse type 1 diabetes in humans.
The vaccine is used to prevent tuberculosis, is considered safe, is inexpensive and has been used since 1921.
Dr. Faustman explains BCG treatment “...transiently modified the autoimmunity that underlies even advanced type 1 diabetes, suggesting that similar therapy may have value in the treatment and even reversal of advanced type 1 diabetes.”
New trial to test whether vaccine reverses type 1 diabetes longterm
"We will be working again with people who have had type 1 diabetes for many years. This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease,” Faustman said in a statement.
The trial will be conducted over a 5year period and will include more frequent vaccine dosing compared to the Phase I testing. Patients will either receive two injections of
BCG four weeks apart or placebo and then an annual injection for four years. BCG vaccine temporarily reversed type 1 diabetes because it eliminates Tcells that stop the pancreas from secreting insulin/ The vaccine is also known to stimulate levels of TNF (tumor necrosis factor) that Faustman and her team showed temporarily eliminates white blood cells responsible for the autoimmune response that causes type 1 diabetes.