Brigham and Women’s Hospital announced earlier this week that they are preparing to launch a clinical trial for an Alzheimer’s vaccine that will test its safety and effectiveness. The vaccine will be administered nasally and is intended to prevent and slow the progression of Alzheimer’s Disease. There has been no specific date announced for when this trial will begin.
The clinical trial will be a single-ascending dose trial, also known as a SAD trial, where trial participants will receive two doses of the nasal vaccine one week apart. All participants will be between the ages of 60 and 85 with early, symptomatic Alzheimer’s Disease. Participants must also be in good general health with no disease expected to interfere with the study, and have had an amyloid-positive PET scan (showing plaque on the brain).
Participants in this trial will receive two doses of the nasal vaccine one week apart. All participants will be enrolled from the Ann Romney Center for Neurologic Diseases of Brigham and Women’s Hospital.
Howard L. Weiner, MD, is the co-director of the Ann Romney Center and has led the way for nearly two decades as they have actively searched for ways to create the first-ever Alzheimer’s vaccine. He said in a press release through the Brigham that the launch of this trial for the nasal vaccine is a remarkable milestone and that they have gathered preclinical evidence that suggests it has high potential.
“If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s,” he said. “It could also be given early to help prevent Alzheimer’s in people at risk.”
The vaccine uses something called Protollin. Protollin is an immune modulator that stimulates the immune system. Protollin is made up of proteins obtained from bacteria and has been safely used in humans in the past as an adjuvant, or as a second biochemical molecule in a vaccine that boosts immune response.
Protollin specifically activates white blood cells found in the lymph nodes on the sides and back of the neck to travel to the brain to remove beta-amyloid plaques, which is the primary component of plaques characteristic of Alzheimer’s disease.
Beta-amyloid plaques are an amyloid from a larger inactive protein. Amyloid’s are waxy, translucent substances that consist primarily of protein and are deposited in some animal organs and tissues under abnormal conditions, such as Alzheimer’s disease.
Tanuja Chitnis, MD, is a professor of Neurology at the Brigham and the principal investigator of the trial. She said in the release that 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,” she said “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 Brigham says 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 each participant’s immune response, including its effects on white blood cells, by examining cell surface markers, gene profiles, and functional assays (measures the functional behavior of the cell).
“The immune system plays a very important role in all neurologic diseases,” Weiner said. “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.”
I-Mab Biopharma (I-Mab) and Jiangsu Nhwa Pharmaceutical (NHWA), which are both headquartered in China, are responsible for the development, manufacturing and commercialization of Protollin.
