Featured Research

from universities, journals, and other organizations

BCG vaccination appears promising as a treatment for people with existing type 1 diabetes, Phase I trial results show

Date:
June 28, 2010
Source:
Massachusetts General Hospital
Summary:
Researchers in Massachusetts have announced the completion of the Phase I BCG clinical trial in type 1 diabetes. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin vaccination as a treatment type 1 diabetes, are actively underway.

Massachusetts General Hospital (MGH) and the Iacocca Foundation have announced the completion of the Phase I BCG clinical trial in type 1 diabetes, as well as the submission of all safety reports to the U.S. Food and Drug Administration (FDA) and the MGH data safety monitoring boards. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin (BCG) vaccination as a treatment for people with existing type 1 diabetes, are actively underway.

Related Articles


"We are making great progress and are really excited to be able to move this potential treatment to the next stage of clinical testing," says Denise Faustman, MD, PhD, director of the Immunobiology Laboratory at the MGH and an associate professor of Medicine at Harvard Medical School.

The results of the MGH trial showed that low-dose, multi-dosing regimens of BCG vaccination were safe in individuals with type 1 diabetes. There were no severe reactions to the vaccine other than the expected inflammation at the injection sites. BCG is a generic drug that is currently approved in the United States for tuberculosis vaccination and for the treatment of bladder cancer.

"This clinical trial is an important event for both the MGH and the Iacocca Foundation, who have been our partners in this process," says Peter Slavin, MD, president and CEO of Massachusetts General Hospital. "We are putting our energies behind moving the trial into Phase II."

The MGH Immunobiology lab, led by Faustman, will now begin planning for a Phase II clinical trial to continue investigating the safety and efficacy of BCG vaccination as a therapeutic agent for the prevention or reversal of type 1 diabetes. The trial will seek to define the exact dose and timing of administration of BCG vaccination to treat advanced type 1 diabetes. The majority of the funds for Faustman's basic research, on which these human studies are based, have come from the Iacocca Foundation. Additional information about the clinical trials can be found at http://www.faustmanlab.org.

"We are very pleased to see this work come as far as it has," says Lee A. Iacocca, chairman of the Iacocca Foundation. "I made a promise to see a cure for type 1 diabetes in my lifetime, and I intend to keep it. The public support of this trial and a trial for people with this disease is my dream."

The MGH clinical trial was a double-blind, placebo-controlled Phase I human clinical trial to evaluate the safety of BCG vaccination in volunteers with type 1 diabetes. The basis of the trial is preclinical work done in the Faustman Immunobiology Laboratory, as well as other laboratories worldwide, showing that temporarily elevating levels of an immune modulator called tumor necrosis factor (TNF) can eliminate the abnormal white blood cells found in mice and humans with type 1 diabetes. Administration of the BCG vaccine is known to raise TNF levels in humans.


Story Source:

The above story is based on materials provided by Massachusetts General Hospital. Note: Materials may be edited for content and length.


Cite This Page:

Massachusetts General Hospital. "BCG vaccination appears promising as a treatment for people with existing type 1 diabetes, Phase I trial results show." ScienceDaily. ScienceDaily, 28 June 2010. <www.sciencedaily.com/releases/2010/06/100628112121.htm>.
Massachusetts General Hospital. (2010, June 28). BCG vaccination appears promising as a treatment for people with existing type 1 diabetes, Phase I trial results show. ScienceDaily. Retrieved December 18, 2014 from www.sciencedaily.com/releases/2010/06/100628112121.htm
Massachusetts General Hospital. "BCG vaccination appears promising as a treatment for people with existing type 1 diabetes, Phase I trial results show." ScienceDaily. www.sciencedaily.com/releases/2010/06/100628112121.htm (accessed December 18, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Thursday, December 18, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Kids Die While Under Protective Services

Kids Die While Under Protective Services

AP (Dec. 18, 2014) As part of a six-month investigation of child maltreatment deaths, the AP found that hundreds of deaths from horrific abuse and neglect could have been prevented. AP's Haven Daley reports. (Dec. 18) Video provided by AP
Powered by NewsLook.com
UN: Up to One Million Facing Hunger in Ebola-Hit Countries

UN: Up to One Million Facing Hunger in Ebola-Hit Countries

AFP (Dec. 17, 2014) Border closures, quarantines and crop losses in West African nations battling the Ebola virus could lead to as many as one million people going hungry, UN food agencies said on Wednesday. Duration: 00:52 Video provided by AFP
Powered by NewsLook.com
When You Lose Weight, This Is Where The Fat Goes

When You Lose Weight, This Is Where The Fat Goes

Newsy (Dec. 17, 2014) Can fat disappear into thin air? New research finds that during weight loss, over 80 percent of a person's fat molecules escape through the lungs. Video provided by Newsy
Powered by NewsLook.com
Why Your Boss Should Let You Sleep In

Why Your Boss Should Let You Sleep In

Newsy (Dec. 17, 2014) According to research out of the University of Pennsylvania, waking up for work is the biggest factor that causes Americans to lose sleep. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins