Posted on 11/17/2021 7:59:58 AM PST by bitt
First human trial for intranasal vaccine for AD represents culmination of 20 years of research led at the Brigham
Brigham and Women’s Hospital is set to begin a clinical trial that will test the safety and efficacy of a new vaccine delivered nasally intended to prevent and slow the progression of Alzheimer’s disease (AD). The trial represents the culmination of nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at the Brigham.
“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” said Weiner. “Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for AD. If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s in people at risk.”
The vaccine uses the immune modulator Protollin, an investigational intranasal agent that stimulates the immune system. Protollin is composed of proteins derived from bacteria and has been used safely in humans as an adjuvant for other vaccines. Protollin is designed to activate white blood cells found in the lymph nodes on the sides and back of the neck to migrate to the brain and trigger clearance of beta amyloid plaques — one of the hallmarks of AD. I-Mab Biopharma (I-Mab) and Jiangsu Nhwa Pharmaceutical (NHWA) are responsible for the development, manufacturing and commercialization of Protollin.
“For 20 years, there has been growing evidence that the immune system plays a key role in eliminating beta amyloid. This vaccine harnesses a novel arm of the immune system to treat AD,” said Tanuja Chitnis, MD, professor of Neurology at the Brigham and principal investigator of the trial. “Research in this area has paved the way for us to pursue a whole new avenue for potentially treating not only AD, but also other neurodegenerative diseases.”
The clinical trial will be a single ascending dose (SAD) trial of 16 participants, all of whom will be enrolled from the Ann Romney Center. Trial participants will be between 60 and 85 years of age with early, symptomatic AD. Participants must be in good general health with no disease expected to interfere with the study and have had an amyloid-positive PET scan. Participants will receive two doses of the nasal vaccine one week apart.
“We are thrilled to see Protollin approved to advance into clinical trials after many years of pioneering work, and we are honored to contribute our expertise in the global effort to develop novel therapies for this devastating disease,” said Dr. Jingwu Zang, founder, chairman and director of I-Mab.
The phase I trial’s primary objective will be to determine the safety and tolerability of the nasal vaccine. The research team will also measure the effect of nasal Protollin on participants’ immune response, including its effects on white blood cells, by examining cell surface markers, gene profiles, and functional assays.
“The immune system plays a very important role in all neurologic diseases,” said Weiner. “And it’s exciting that after 20 years of preclinical work, we can finally take a key step forward toward clinical translation and conduct this landmark first human trial.”
Funding: This study is funded by I-Mab and NHWA.
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I-Mab is a Chinese company...?
Up your nose with a rubber hose, JB!................
So is NHWA...
Hint to scientists....
You need a real no vaccine control group or your trial is not worth &^%$!
Already skeptical, that's as far as one needs to read.
I'll take my chances and consider myself ahead of the game. Should one get alzheimers, one's inclination would be to just deal with it.
Please hurry.
After losing 2 grandparents to that disease I can tell you flat out if I was diagnosed with it I’d volunteer even if it meant it would kill me in the end to take this.
Watching the slow progression of the disease made me realize it’s only quality that will keep me around and not quantity if I were to succumb to it.
Even if the chances were greater than 50/50 I would react wrong to it and it kills me I’d do it just to try and help others fighting it further down the road.
I truly don’t want to go out that way.
G
Agree, there is no downside to experimental treatment if you’ve received the diagnosis.
Anything that extends quality of life even at the expense of quantity is a win with this disease.
There is growing skepticism among research scientists that amyloid plaques are the cause of Alzheimer’s functional degeneration. They believe they are the result of other enzyme deficiencies that suppress the production of acetylcholine needed to maintain neuron efficiency. Time will tell but both Lilly and Pfizer are developing competing amyloid plaque targetting drugs and are already well into clinical trials with mixed results.
Hmmmm... Just this week I read that Brigham and Women's Hospital had made progress against Alzheimer's with a derivative of cacao (apparently different from cocoa... dark chocolate.)
So are we just calling every treatment a “vaccine” these days or what?
So many relatives affected by this awful disease.....Father, Father-in-Law, Mother-in-Law. It would be an absolute Godsend for mankind if this drug proves effective.
No no! Only jabs approved by Dr. Frankenstein Fauci!
I got a Hepatitis shot when in the 1990s, no one called it a vaccine.
Agreed. We’ve watched too many go through it. It’s devastating to all involved. I really hope they find an answer soon. In the meantime, there is a thought that diets high in saturated fats I think it is, are the cause of depositing too much of the plague on the brains. Can’t remember the details now, bUT there was an article on fr not too long ago on it.
Let’s pray this brings hope and light back into people’s lives.
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