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From the Boston Business Journal:
http://www.bizjournals.com/boston/news/2017/06/10/mgh-study-showsvaccine-could-permanently-reverse.html

MGH study shows vaccine could
permanently reverse type 1 diabetes
Jun 10, 2017, 1:00pm EDT

Two years after beginning a groundbreaking
phase II clinical trial in reversing type 1diabetes, researchers from Massachusetts
General Hospital have discovered that a
vaccine could permanently reverse thedisease.
The five-year long, mid-stage clinical trial islooking at the bacillus Calmette-Guerin
vaccine, an inexpensive and already generic
vaccine that is used around the world toprevent tuberculosis.
Dr. Denise Faustman, director of the
Massachusetts General Hospital
immunobiology laboratory and principal
investigator of the trial, said interim results
show that unlike other vaccines that irritate
white blood cells to prompt an immune
response, the BCG vaccine affects white bloodcells at the genetic level, regulating which

COURTESY/MGH

Dr. Denise Faustmangenes are expressed and which are not. The body consequently stops producing
the abnormal white blood cells responsible for the autoimmune disease,suggesting that the vaccine could permanently reverse type 1 diabetes.
“The vaccine actually resets your genes to restore normality,” Faustman said in aninterview. “What it is showing is it’s not merely the vaccine you’re being given andit causes inflammation or an immune response. It’s actually working at the mostbasic DNA level to normalize expression of genes related to this abnormal
immune response.”
The findings were presented Saturday during the 77th Scientific Sessions of theAmerican Diabetes Association, one of the largest diabetes gatherings in thecountry.
The findings not only bring a broader understanding to ongoing studies of thevaccine for type 1 diabetes, but also explain why the vaccine is so effective intreating other autoimmune disorders — from multiple sclerosis (studies with thevaccine are ongoing in Italy) to food allergies (studies with the vaccine areongoing in Australia).
“It’s because the immune system hasn’t bent been reset correctly in childhood,”
Faustman said. “There are trials using this vaccine to reverse allergies in Australia.
It’s putting the environment back into people.”
Used in China, Africa and South America to vaccinate against TB, the BCG
vaccine has been utilized 4 billion times over the last 100 years. Last year alone,
100 million doses of the vaccine were given to newborns. Because TB isn’t
common in the U.S., children here do not receive the vaccine.
The microorganism originates from the dirt. Faustman said the rise ofautoimmune disorders, and the increase of food allergies and gluten intolerance,
is tied to the fact that humans no longer interact with the dirt in the way theyonce did.
Clinical trials with the vaccine are ongoing. The lab has nearly recruited all of the150 people for Phase II clinical trials, which have been funded largely by support
from the Iacocca Family Foundation. Faustman’s lab is looking for the final $5
million of the $25 million necessary to finish the trial.
The goal of the latest clinical trial is to replicate results from the first phase ofclinical trials, as well as analyze the dosing necessary to make the vaccine work

quickly. Faustman’s lab has also conducted six-years of follow-up on Phase I
patients within the latest study to see how patients are doing long-term. The
results from those findings will be published by the end of the year.
Results from Phase 1 clinical trials, published in 2012, showed that the treatment
eliminated defective immune cells that attack the pancreas, temporarily restoring
the ability of the pancreas to produce small amounts of insulin. The data from that
initial study only tracked patients over 20 weeks.
Success would be groundbreaking. Using an inexpensive vaccine that's alreadygeneric to reverse juvenile-onset diabetes would save the health care systembillions of dollars and save patients from lifelong complication associated with thedisease. According to the U.S. Centers for Disease Control and Prevention, annual
medical costs for children with either type 1 or type 2 diabetes is $9,061 — about
six times the amount for youths without the disease.
While most vaccines are used preventatively, Faustman envisions making thisvaccine available to anyone suffering from an autoimmune disorder.
“We’re trying to figure out the dose that’s effective and how significant of an
impact it can have,” Faustman said.
Jessica Bartlett
Reporter
Boston Business Journal