TB Vaccine Promising as New Way to Fight Type 1 Diabetes


TB Vaccine Promising as New Way to Fight Type 1 Diabetes

WEDNESDAY, Aug. 8 (HealthDay News) -- A small trial of a vaccine already approved for tuberculosis found that the vaccine can kill the rogue autoimmune cells that are active players in type 1 diabetes.

There were no changes, however, in the need for insulin among those with longstanding diabetes who got the vaccine, the researchers added.

"What we saw with two vaccines, given four weeks apart, was the death of bad T-cells," said study author Dr. Denise Faustman, director of the immunobiology laboratory at Massachusetts General Hospital in Boston. "We also saw that regulatory T-cells came on -- these are the good-guy T-cells. And the pancreas went on briefly, and this was in people who were 15 years out from their type 1 diagnosis."

"This doesn't mean that people were throwing their insulin syringes away," Faustman said. "But the exciting part is that even decades after the disease begins, the cells in the pancreas can kick in again."

Results of the study appear online Aug. 8 in the journal PLOS One.

The vaccine, which has been approved by the U.S. Food and Drug Administration, is called bacille Calmette-Guerin (BCG), and has been used against tuberculosis for about 90 years, Faustman said. BCG also is used as a treatment for bladder cancer.

The vaccine works by increasing levels of a substance known as tumor necrosis factor (TNF). High doses of TNF can be toxic, but the vaccine doesn't appear to raise levels of TNF too high.

According to the U.S. Centers for Disease Control and Prevention, the only groups that shouldn't receive the live vaccine are those whose immune systems are compromised, such as people who have HIV or people who have received an organ transplant. The CDC also recommends against giving the vaccine to pregnant women because it hasn't been well-studied in this population.

In 2001, Faustman's team tested a similar substance in mice and found that it destroyed the harmful T-cells and allowed the insulin-producing cells in the pancreas to regenerate and produce insulin.

The question was: Would such regeneration take place in humans with type 1 diabetes if the immune-system attack that causes type 1 diabetes in the first place was stopped?

To answer that question, Faustman and her colleagues recruited six people with type 1 diabetes who were randomly assigned to receive two injections of either the vaccine or a placebo, and they were compared to one control group without diabetes and one with the disease.

The average duration of type 1 diabetes at the beginning of the study was 15.3 years, and the average age of those with diabetes was 35.

During the 20-week study, two out of the three people treated with BCG had evidence of bad T-cell death and increases in the levels of protective T-cells. They also showed an elevation in levels of a substance called C-peptide that indicates insulin production.

Faustman said it's not clear why BCG didn't appear to help one of those treated with it, but, she added, at the end of the study, the individual's level of C-peptide began to increase.

She also said it's not yet certain whether more frequent doses or higher doses would be needed to restore more pancreatic function, but it may matter how long someone has had the disease.

Faustman said, however, that no matter how long someone has had the disease, they'll likely get some function back.

"We may only restore 5, 10, 20, 50 or 60 percent of function -- we just don't know yet -- but any restoration of C-peptide helps to prevent diabetes complications," she said.

One expert said the finding was important, but many questions remain.

"This study shows that by increasing TNF, they can induce the death of the autoreactive T-cells that destroy the cells that make insulin, and they transiently increase C-peptide levels," said Dr. Spyros Mezitis, an endocrinologist at Lenox Hill Hospital in New York City. "But what happens after 20 weeks? How often would they need to give this vaccine?"

"I'm concerned about increasing the levels of TNF in the body," he added. "They're saying that only the insulin-secreting cells are affected, but what are the long-term effects if it's given repeatedly? What about the growing cells in children, because if it works it would be used in children."

Still, he said, "this is important research that helps us understand the pathophysiology of type 1 diabetes."

Faustman said that BCG has an excellent safety record, and has been given to billions of adults and children worldwide to prevent tuberculosis.

Faustman and her colleagues are currently developing phase II trials to test using higher levels of the vaccine.

More information

Learn more about type 1 diabetes from the National Library of Medicine.

SOURCES: Denise Faustman, M.D., Ph.D., director, immunobiology laboratory, Massachusetts General Hospital, Boston; Spyros Mezitis, M.D., endocrinologist, Lenox Hill Hospital, New York City; Aug. 8, 2012 PLOS One, online


I think its fasanating. And hope to see more come from this. Does anyone get the feeling they've been dealing with this so long that any cure, or treatment we could benefit from is to little to late? All I could focus on was the statement There were no changes, however, in the need for insulin among those with longstanding diabetes who got the vaccine, the researchers added. I think at nearly 30 years that would put me in the longstanding diabetes category. Still though it is an exciting development and I certainly hope it benefits many with Type 1.

6 people is an incredibly insignificant sampling and yes 20 weeks is a short period; but it does seem to be researching some interesting possibilities and that's all good!

If they need test pilots, sign me up! I have thousands of syringes ready to fire away in my garage! And a turkey baster, bike pump, sawzall, all sorts of gear. I’m ready to light the candle!

LOL nothing ventured, nothing gained. I certainly wouldnt mind um being a guinea pig.

I don't know whether Dr. Faustman is still accepting patients in the trial. I have been participating in the trial for over 2.5 years, and I know Brunetta has been in it for a while, too.

If you're interested, go to faustmanlab.org, and there is a link for sending emails to inquire.

I am scheduled to return to Boston in October, but I'm not sure whether I can afford it. It sure will be a shame if I can't - I have a ton of time, energy and money tied up in the trial, and I'd hate to have to drop out.


Thanks for the information. I'll have to check it out.

Amazing. Amazing.

Yes it is a small trial. But if Dr Faustman can successfully prove the concept works then (hopefully) she can get the funding to go on to bigger tests.

Very interesting indeed. The important thing to consider is that while such a treatment might not make us totally independent of insulin, it could result in some insulin production being restored. Even being able to make a small amount of our own insulin would result in better control, fewer severe highs, and reduced complications. That alone would, to me, be a success! I would not mind having to continue to check my BGs or even to continue taking shots or using a pump. BUT, to have better control and know that I won't face complications would be a huge bonus.

Hmmm, I'm not sure that some "home grown" would be useful, unless you knew for sure it was consistent? If it was on and off or the rate varied, etc. it might be more trouble than it's worth?

Maybe so, Acid. Who would want a never-ending Honeymoon period ( just a diabetes honeymoon , that is.An otherwise never-ending honeymoon hmmm lol); with in and out insulin production? But I am convinced that Dr.Faustman's research will have some benefit.. as MybustedPancreas noted, just knowing that we could hold severe complications at bay would be worth it to me!!

God bless,

Hi AR. I have some "home grown" insulin, which has shown up for the same four afternoon hours for years. It's a bit of a nuisance, since I have to split my Levemir three ways in order not to go low during those hours (nightly, first thing in the morning and 2:30PM). I'm not complaining though. I read somewhere that if you make a little insulin, there is less chance of complications; reading the above, maybe that's the added C-Peptide. My own complications seem to have been caused by the Pernicious Anemia that I had for many years before Diabetes; those complications have not even worsened since the 20 years or so of Diabetes began. I am in favor of making our own insulin, even just a little bit...

any kind of progress is better than no progress at all and this looks quite promising.
Fingers crossed :D

I agree, AR and Brunetta. In fact when people talk about "preserving beta cell production" I always wonder about it because it seems to just make things inconsistent and hard to manage when the faucet turns on and off!

Hi Trudy. I wonder about the idea that making your own insulin could be the protective factor? So many T2s have complications and most of us do produce our own insulin? I remember that Richard157 posted a study last summer by the Joslin Centre in which they said that they were close to isolating that protective factor. I wonder if they have made any progress?
I do agree that any hope of assisting T1s to produce even a little bit of insulin is hopeful. Cheers! Joanne

Hi Joanne. Yes, my reading Richard's posting about the Joslin studies is what I was remembering re complications and insulin production. He remains the expert! Cheers!