Celiac vaccine proves no better than placebo

If you have celiac disease and have been anxiously awaiting the vaccine that would allow you to eat gluten again, I have disappointing news. Unfortunately, the vaccine, Nexvax2 failed to perform.

There has been talking of the vaccine for many years, but last year the Massachusetts-based company ImmusanT began a phase 2 trial designed to demonstrate the abilities of their vaccine to protect celiac sufferers from the ill effects of gluten.

Celiac is an autoimmune disease that targets the lining of your small intestine. Those with the disease will typically show positive blood tests and an intestinal biopsy that measure such damage.

The leading researcher is a wonderful, dedicated man

I well remember meeting Dr. Bob Anderson, a wonderful man, and dedicated gastroenterologist who has easily spent over 20 years of his life dedicated to celiac research.

I was speaking at an event hosted by Beyond Celiac when I met Bob. Alice Bast, CEO of Beyond Celiac, introduced us. Alice, too, has dedicated her life to making celiac disease better known, better diagnosed, and with the advent of a successful vaccine, easy to live with. She has supported Bob and ImmusanT from the beginning.

Dr. Anderson began his work in 1998 in England, then moved to Australia and then joined with ImmusanT here in the U.S.

The design of the vaccine seemed sound

The vaccine utilizes three small segments of the gluten protein that are known to activate the immune system (T-cell reaction) and create intestinal damage.

Nexvax2 was first announced in 2012, but Phase 1 studies begin in 2016 and appeared promising. It was then we began to hear more about the vaccine’s potential.

If Phase 2 had been successful, Phase 3 trials would have been next in order to achieve FDA approval. Sadly, the vaccine didn’t make it out of Phase 2.

The vaccine was to be an injection, working on the premise that if very small amounts of the proteins were injected and gradually increased over time, the immune system would build up resistance and no negative effects would occur.

It was targeted at those celiac disease patients who are HLA-DQ2.5 positive, a genetic profile that represents about 90% of all who suffer from the disease.

$40 million later and results were abysmal

After raising $40 million to launch their phase 2 trial, the results were just released and they were devastating.

The vaccine failed to perform better than a placebo, meaning it had no positive effect.

ImmusanT has not shared the precise data from the trial, but clearly it was sufficiently bad enough to convince them of the futility of pursuing the trial.

Their only comment was that it was safe and well-tolerated – fine, but add “ineffective” and you clearly have a problem.

The company has a type 1 diabetes vaccine they are working on, but since it’s based on the same technology as the Nexvax2, it’s unlikely to have any better results.

Where does that leave the millions who must avoid gluten?

Unfortunately, we are back in a gluten-free diet to ensure the best health outcomes for both celiac and gluten-sensitive patients.

Data that reveals ALL humans experience some degree of the leaky gut with gluten ingestion is a cautionary tale for gluten consumption in general.

Remember, gluten ingestion when you’re celiac or gluten-sensitive is less about quantity and more about quality. Meaning it truly is a zero-tolerance policy. There’s no cheating that won’t compromise your health long-term.

Cheating truly isn’t an option; not if you value your health

If you cheat and can’t “feel” it with any dramatic symptoms, it doesn’t mean that your immune system isn’t registering the gluten and causing ill effects within your body.

If you’ve been hopeful about the vaccine, I’m sorry to share the bad news. I’ll admit I wasn’t holding out much hope for its success. It’s certainly possible, but there are so many “issues” with vaccines, that even the ones that are deemed a success, often reveal later, dangerous side effects that weren’t initially identified.

Let’s focus on the positive

The good news is that living gluten-free doesn’t have to be difficult and you can still eat delicious food while enjoying robust health.

Here at Root Cause, we are committed to finding you the best options to successfully maintain your gluten-free diet while enjoying your food.

Is your health not where you want it?

If you are not enjoying the robust health you deserve, but you’re not really sure what to do, let us help you.

We specialize in getting to the root cause of why your body is giving you symptoms and will create a personalized program to help you regain your best health.