First trial of a vaccine against Alzheimer’s launches

For some time, researchers have looked to the brain's immune system as a key factor in the development of Alzheimer’s disease. Now, after years of lab work, patients with Alzheimer’s disease are set to receive a vaccine that stimulates the immune system in the hope it will slow or even prevent the disease.

The first-in-human trial run by the Brigham and Women's Hospital (BWH) in Boston, Massachusetts, will involve an intranasal vaccine using the immune modulator Protollin, an investigational intranasal agent that stimulates the immune system.

Composed of proteins from bacteria, Protollin is designed to activate the white blood cells in the lymph nodes on the sides and back of the neck, which researchers hope will then migrate to the brain and trigger the clearance of beta amyloid plaque, one of the hallmarks of Alzheimer’s disease. Protollin has been used safely in humans as an adjuvant for other vaccines.

Dr Howard Weiner co-director of the Ann Romney Center for Neurologic Diseases at BWH described the trial as a “a remarkable milestone”.
He added “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 phase 1 trial will determine the safety and tolerability of the nasal vaccine as well measure the effect on participants’ immune response, including its effects on white blood cells by examining cell surface markers, gene profiles, and functional assays, says BHW.

“For 20 years, there has been growing evidence that the immune system plays a key role in eliminating beta amyloid,” said Professor Tanuja Chitnis from BWH 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 Alzheimer’s disease, but also other neurodegenerative diseases.”

Finding effective treatments for neurological diseases including Alzheimer’s has been extremely challenging, leading several big pharma companies to throw in the towel in the past decade, including Amgen and Pfizer.

However, there has been renewed interest across the industry in recent years, culminating in the approval of the first treatment for Alzheimer’s disease, Aduhelm, although the drug’s launch has been marred by controversy.

Earlier this week, following reports of the death of a 75-year-old Canadian woman who was participating in a clinical trial for the drug, safety concerns are growing.