What The Headline About A Vaccine Against Type 1 Really Means

The headlines this morning are certainly encouraging: "Vaccine Promising Against Type 1 Diabetes." Sometimes they're using stronger language, such as "Is Vaccine a Cure For Type 1 Diabetes?"

But this is the modern media at work. It is especially common in cancer reporting, where we see words like "promising" and "potential" in headlines with extraordinary frequency, yet over the last forty years it's hard to assert, according to the data, that too many of those "promising" or "potential" breakthroughs ever amounted to anything. In fact, more often than not, these headlines are from pre-clinical trials, meaning they haven't yet investigated the treatment in living human beings.

It's not that the latest headline about a vaccine used against type 1 diabetes shouldn't give us all a little hope or encouragement that it may pan out. Rather, instead of encouraging passive hope, it should encourage action—namely, participation in a clinical trial.

The Study

The study, "Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes" appeared in the journal PLoS One and the most important term in the title is the first one: proof-of-concept.

Authored by researchers from Harvard, the study is a double-blind, placebo-controlled trial of adults with type1 diabetes who had had the disease for an average of 15.3 years. It involved a grand total of six subjects: meaning that six subjects were randomized to get either the vaccine or a placebo. So, with just three people receiving the vaccine, it is extremely difficult to draw any grand conclusions from a sample size of three.

The vaccine in question is a generic Bacillus Calmette-Guerin (BCG) vaccine. The researchers applied the immunotherapy to stimulate tumor necrosis factor (TNF). The TNF kills the autoimmune T lymphocytes that destroy type-1 diabetes causing, insulin-secreting pancreatic beta cells while apparently managing to leave healthy T-cells alone. It also improved insulin sensitivity (according to measured C-peptide levels).

In two of the three patients that received the vaccine—as well as one control patient who received a placebo but during the trial developed acute Epstein-Barr virus infection (a known TNF inducer)— tests "exclusively showed increases in dead insulin-autoreactive T cells … C-peptide levels (pmol/L) significantly rose transiently in two BCG-treated subjects" and to a lesser extent, in the EBV-infected subject compared to a group of diabetics the researchers used as reference subjects.

Study Conclusions

Here's the study's conclusion:

"We conclude that BCG treatment or EBV infection transiently modified the autoimmunity that underlies type 1 diabetes by stimulating the host innate immune response. This suggests that BCG or other stimulators of host innate immunity may have value in the treatment of long-term diabetes."

They also wrote that trials in the future should look into possibly higher doses of BCG or more frequent administration of the vaccine.

Action

Typically, studies that conclude with something to the effect of "further studies are needed to confirm these findings" are horribly frustrating. We can all say that about anything. It reads like a cop-out.

But in a proof-of-principle trial such as this one, these results should encourage people to participate in those "further studies." As it is, clinical trial participation among adults in the US is frighteningly low. It is also replete with mythology and misinformation.

Check out the Facts & Figures offered by the Center for Information & Study on Clinical Research Participation (CISCRP).

While participation doesn't automatically equal progress or breakthroughs, this much is true: Without participation, there is no progress and there are no breakthroughs.

Get a Free Diabetes Meal Plan

Get a free 7-Day Diabetes Meal Plan from Constance Brown-Riggs who is a Registered Dietitian-Certified Diabetes Educator and who is also a national spokesperson for the American Dietetic Association.

Just enter in your email below to download your free Diabetes Meal Plan.

By clicking Submit, you agree to send your info to BattleDiabetes.com who, in addition to 3rd party partners, may contact you with updates, products and information and we agree to use it according to our privacy policy and terms and conditions.

More Articles

More Articles

Two kinds of edema are associated with diabetes: peripheral edema and diabetic macular edema. Peripheral edema is swelling in your lower legs,...

It is important for people with type 2 diabetes to follow a carefully recommended diet plan. The U.S....

With diabetes, your blood sugar levels...

Diabetes can cause damage to nerves and blood vessels, which can lead to foot sores and infections. Nerve damage can cause a loss of feeling in...

It is common knowledge that people with (or without) diabetes should exercise regularly. But why is exercise so important if diet appears to be...

Many diabetics are told by their doctors to completely eliminate bread from their diet. While store-bought white bread is one of the worst foods a...

So you paid a visit to the doctor’s office, and now the word “diabetes” has joined your regular vocabulary.

You’re bound...

Poor sleep can worsen diabetes symptoms, but burning enough calories may not be the only factor to consider when it comes to how exercise...

Having diabetes can present many different challenges including what to do about drinking...

Potassium is a vital part of our everyday diet. Foods high in potassium include bananas, avocados, yogurt, beans, and fish. Like all nutrients,...

Tinnitus is a common condition affecting around 50 million adults in the U.S. It's defined as a "ringing in the ears" that can lead to difficulty...

The so-called "diabetic diet" is not a diet at all. In fact, there are several methods that can be used to create healthful meals that meet the...

Fainting, also called syncope, results from a temporary insufficiency in the supply of blood to the brain. Syncope can be the result of many...

People who have either type 1 diabetes or type 2 diabetes can...

Diabetic test strips are one of the biggest expenses in diabetes care. People who are on a fixed income need to watch every penny that they spend...