A Boston hospital announced the launch of its first human clinical trial of a nasal administration of the vaccine for Alzheimer's disease early today.
As specified in the news site Fox News report, in a statement, Boston's Brigham and Women's Hospital said its move represents the culmination of two decades of research at the institution.
Dr. Howard Weiner, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, considered it a "remarkable milestone."
He added that if clinical trials in humans show that the nasal vaccine is safe and effective, this could signify a harmless treatment for those suffering from Alzheimer's disease. Also, it could be given early to help prevent Alzheimer's in those who are at risk.
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The clinical trial for the nasal vaccine will examine 16 people aged between 60 and 85 years old with early, symptomatic Alzheimer’s
The 1st Human Clinical Trial
This first human clinical trial for the intranasal vaccine is designed to prevent and delay the progression of Alzheimer's.
In an interview with the news site, Weiner discussed the mechanism of the said diseases, pointing out that individuals in their 50s and 60s without Alzheimer's symptoms are developing it.
According to Weiner, as people get older, the immune system typically acts to combat the factors involving Alzheimer's disease off. Furthermore, as people get older, the immune system is not as robust in doing that.
Furthermore, through an entire series of experiments, those involved in this initiative discovered they could give the nasal vaccine, a type of bacteria used in other vaccines. It stimulates the immune system, and then the cells enter the brain and combat the disease, explained Weiner.
They have been working on this vaccine for a long time now. Many issues like understanding the mechanism, having the vaccine manufactured and working with the Food and Drug Administration were encountered, and the team finally made it.
'Protollin'
As specified in the report, the vaccine uses the Protollin immune modulator, an investigational intranasal agent that fuels the immune system.
Protollin comprises proteins derived from microbes and has been used safely in humans. It is developed to stimulate white blood cells that exist in lymph nodes on the sides and the back of the neck to migrate to the brain and generate clearance of beta-amyloid plaques, which the hospital noted as among Alzheimer's disease's hallmarks. .
The study is financially backed by I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical, which are responsible for the development, production and commercialization of Protollin.
The clinical trial will examine 16 people aged between 60 and 85 years old with early, symptomatic Alzheimer's, and all study participants will be signed up from the Ann Romney Center, a similar CBS Boston report via MSN News specified.
Identifying Safety Tolerability of the Vaccine
As specified in the hospital's press release, the patients need to have an "amyloid-positive" PET scan and be in good health condition, in general.
The objective of this Phase I trial will be to identify the nasal vaccine's safety and tolerability, on top of measuring the effect of nasal Protollin on the immune response of the participants, including its impacts on white blood cells.
Weiner also said the immune system plays a vital role in all neurologic diseases. More so, it is exciting that after two decades of preclinical work, "we can finally take a key step" ahead toward clinical translation and carry out this milestone first human trial.
Report about the Boston hospital's clinical trial of the nasal vaccine is shown on WCVB Channel 5 Boston's YouTube video below:
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