Brigham and Women’s Hospital in Boston is set to begin a clinical trial that will test the safety and efficacy of a new vaccine delivered nasally that has been developed to prevent and slow the progression of Alzheimer’s disease (AD).
The launch is a remarkable milestone, said Howard L. Weiner, MD, codirector of the Ann Romney Center for Neurologic Diseases at the Brigham, in a press release. “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,” he said.
An estimated 55 million people live with dementia, which is a general term for impaired ability to remember, think or make decisions beyond what might be expected from the usual consequences of growing old, according to the World Health Organization (WHO). Alzheimer’s disease is the most common form of dementia, and may account for 60 to 70 percent of cases.
Vaccine Designed to Trigger an Immune Response to Fight Disease Process
The vaccine uses the immune modulator Protollin, an intranasal agent that’s made of proteins derived from bacteria and has been used safely in humans as an adjuvant for other vaccines. An adjuvant is an ingredient used to make vaccines work better by creating a stronger immune response, according to the Centers for Disease Control and Prevention (CDC).
According to researchers, Protollin is designed to activate white blood cells found in the lymph nodes on the sides and back of the neck to go to the brain and trigger clearance of beta amyloid plaques which is one of the hallmarks of AD, according to researchers.
In the brain of someone with Alzheimer’s, there are abnormal levels of the protein amyloid that clump together and form plaques. These collect between neurons and disrupt cell function, according to the National Institute on Aging. Many experts believe that reducing amyloids would reduce memory loss and cognitive decline.
Phase 1 Trial Will Test the Safety and Tolerability of Vaccine
The trial contains 16 participants between 60 and 85 years of age with early, symptomatic AD. All the participants are in good general health with no disease expected to interfere with the study and have had an amyloid-positive PET scan.
Each of the subjects will get two doses of the nasal vaccine, with the second dose being delivered a week after the first. This trial’s primary objective is to find out if the vaccine is safe and well tolerated, and the impact of nasal Protollin on participants’ immune response, including its effects on white blood cells, will also be measured.
“This vaccine goes to show the immune system is important for so many things outside of infection, such as neurological diseases, cancers, heart disease, and the list goes on,” says Purvi Parikh, MD, a clinical assistant professor at NYU Grossman School of Medicine and immunologist at NYU Langone, both in New York City. Dr. Parikh is not involved in the clinical trial.
“It’s exciting that we can train our immune system with vaccines to fight these disease in an effective way,” she says.