Thanksgiving update with BCG vaccine study results

It’s been 6 months since my last post, largely due to a busy schedule and technical issues. I changed computers, and had a little trouble transferring my site management setup. I’ve also had to stop taking Plaquenil/hydroxychloroquine this summer, and the months following made it clear that it had been helping my health. As a result, I’ve been adjusting my remaining treatments to try filling in the gaps.

There are several stories that I want to catch up on, but I thought I would start with an update from June on the BCG vaccine. Long-time readers may recall a posts from 2015 and 2016 on small trials of the BCG vaccine for diabetes patients. Now, the results of one small trial are available, and they appear promising, though there are some caveats:

Patients with long-standing type 1 diabetes given the bacillus Calmette-Guerin (BCG) vaccine showed modestly better glycemic control through a mechanism that appeared to be epigenetic, according to a long-term follow-up study that has generated controversy here.

Starting after the third year of follow-up in the 46 patients in early-phase trials, hemoglobin A1c levels were lower among patients who got the two doses of the tuberculosis vaccine (6.18% vs 7.07% with placebo and 7.22% among untreated T1D patients, P=0.02).

Among the phase I randomized trial patients followed for 8 years, A1c levels were 6.65% versus 7.22% in the placebo group (P=0.0002), Denise Faustman, MD, PhD, of the Massachusetts General Hospital (MGH) Immunobiology Laboratory in Boston, and colleagues reported at the American Diabetes Association annual meeting, days after publication of the overall findings in npj Vaccines

However, a statement from William Cefalu, MD, ADA chief scientific, medical and mission officer, warned that the “findings must be interpreted with caution and cannot be generalized to the more than 1.5 million Americans living with type 1 diabetes.

“It is also critical to note that all of the study participants continued to use standard insulin therapy throughout the trial; it’s not a situation whereby the treatment changed their standard of care (patients no longer required insulin),” he said in the statement…Cefalu called for an adequately-powered, better-controlled intervention trial to show whether there is any efficacy to the BCG treatment…

 

Six trials with hundreds of patients are ongoing, Faustman said, although phase III might not be necessary, given the long-standing use of this vaccine as safe. “More data to come.”

The news even made some mainstream outlets like NBC and Newsweek. While noting that six trials were ongoing, I didn’t see any specific information on the SS trial that was alluded to in 2016. Still, these results, while limited in scope, could inspire more investment and an expansion of autoimmune diseases studied as targets for treatment by the BCG vaccine. The full study is available publicly from npj Vaccines.

I’d like to end the post by wishing readers a happy Thanksgiving (even if you aren’t in the United States). I hope that we all have things to be thankful for, no matter what the state of our health.

Posted in Clinical Trials, Research, Treatment Tagged with: ,
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