Brigham and Women’s Hospital in Boston, US, is set to commence a clinical trial of a new intranasal vaccine for the treatment of Alzheimer’s Disease (AD).
The new vaccine uses Protollin, which activates the immune system, and is being developed to prevent and slow the disease progression.
Made of proteins drawn from bacteria, Protollin activates white blood cells in the lymph nodes in the neck and sends them to the brain to clear beta-amyloid plaques.
The single ascending dose (SAD) trial will feature 16 subjects aged between 60 and 85 years and with early, symptomatic AD.
Enrolled from the Ann Romney Center, the participants will be given two doses of the vaccine with a one-week gap.
Brigham & Women’s Hospital Neurologic Diseases Ann Romney Center co-director Howard L Weiner said: “The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone. 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 non-toxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s in people at risk. The immune system plays a very important role in all neurologic diseases.”
The primary goal of the Phase I trial will be to ascertain the safety and tolerability of the nasal vaccine.
The nasal Protollin’s effect on participants’ immune systems, including on white blood cells, will be measured by the researchers.
Brigham and Women’s Hospital Neurology professor Tanuja Chitnis said: “This vaccine harnesses a novel arm of the immune system to treat AD.
“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.”
Jiangsu Nhwa Pharmaceutical (NHWA) and I-Mab Biopharma (I-Mab) are responsible for the development, manufacturing and marketing of the immune modulator Protollin.