Alzheimer nasal vaccine

First human trial of Alzheimer disease nasal vaccine to begin at Boston hospital.

Brigham and Women's Hospital in Boston said this week it will launch a small Phase I clinical trial to test the efficacy and safety of a nasal vaccine against Alzheimer disease (AD). The announcement comes after nearly 20 years of research led by Howard L. Weiner, MD, co-director of the hospital's Ann Romney Center for Neurologic Diseases. The trial will include 16 participants aged 60-85 years, all with early symptomatic Alzheimer disease who are otherwise healthy in general. They will receive two doses of the vaccine 1 week apart. If the trial is successful, a larger study would be needed to test the drug's effectiveness. The vaccine uses a substance that stimulates the immune system (Protollin—I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical), and "is designed to activate white blood cells found in the lymph nodes on the sides and back of the neck to migrate to the brain and trigger clearance of beta amyloid plaques—one of the hallmarks of AD," the hospital said. It noted the substance has been found to be safe in other vaccines. The researchers seek to "determine the safety and tolerability of the nasal vaccine" in the trial and observe how it affects participants' immune response, in particular their white blood cells. Tanuja Chitnis, MD, professor of neurology at Brigham and Women's Hospital and principal investigator of the trial, 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." 

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波士顿医院开始首次对阿尔茨海默病鼻腔疫苗进行人体试验
波士顿布莱根妇女医院本周表示，将启动一项小型 I 期临床试验，以测试鼻用疫苗对抗阿尔茨海默病 (AD) 的有效性和安全性。该公告是在该医院 Ann Romney 神经疾病中心联合主任 Howard L. Weiner 医学博士领导的近 20 年研究之后发布的。该试验将包括 16 名年龄在 60-85 岁之间的参与者，所有参与者都患有早期有症状的阿尔茨海默病，他们总体上都很健康。他们将间隔 1 周接种两剂疫苗。如果试验成功，则需要进行更大规模的研究来测试药物的有效性。该疫苗使用一种刺激免疫系统的物质（Protollin—天境生物制药和江苏新华制药），“旨在激活颈部两侧和背部淋巴结中发现的白细胞迁移到大脑并触发β淀粉样蛋白斑块的清除——这是AD的标志之一，”医院说。它指出，已发现该物质在其他疫苗中是安全的。研究人员试图在试验中“确定鼻用疫苗的安全性和耐受性”，并观察它如何影响参与者的免疫反应，尤其是他们的白细胞。布里格姆妇女医院神经病学教授、该试验的首席研究员、医学博士 Tanuja Chitnis 说：“该领域的研究为我们开辟了一条全新的途径，不仅可以治疗 AD，还可以治疗其他神经退行性疾病。疾病。”