摘要
目的:ACC-001长期安全性和耐受性(),淀粉样治疗疫苗,为了对中轻度阿尔兹海默病进行评价。 实验进行:在美国、欧洲联盟和日本进行了随机2a试验的2a期扩展研究。 方法:ACC-001在相同剂量给药(3, 10,3,和30μG)四接种将受试者随机亲本研究;ACC-001给予QS-21佐剂。在积极治疗和6个月随访期间评估了安全性、耐受性和免疫原性。 结果:扩展研究中ACC-001 + QS-21在美国(n = 110)和欧盟(n = 50),和日本(N = 53)有较好的耐受性;安全性是相似的,在相关的研究中观察到,并没有识别新的安全信号。总体而言,注射部位反应是这些研究中最常见的不良事件。抗淀粉样蛋白的抗体滴度引起的所有群体,具有最高滴度观察受试者接受ACC-001 + QS-21双方的父母和扩展研究。 结论:老年痴呆症人说,长期接触ACC-001 + QS-21的耐受性良好,这表明副作用没有抗淀粉样蛋白主动免疫构成主要限制。与其他疗法相比,最高的抗β淀粉样蛋白的IgG抗体滴度引起ACC-001 + QS-21在长期治疗中。
关键词: 阿尔茨海默病,淀粉样β,淀粉样蛋白斑,抗体,免疫治疗,疫苗
Current Alzheimer Research
Title:Long-Term Extensions of Randomized Vaccination Trials of ACC-001 and QS-21 in Mild to Moderate Alzheimer’s Disease
Volume: 14 Issue: 7
关键词: 阿尔茨海默病,淀粉样β,淀粉样蛋白斑,抗体,免疫治疗,疫苗
摘要: Objectives: Long-term safety and tolerability of ACC-001 (vanutide cridificar), an antiamyloid- beta therapeutic vaccine, was evaluated in subjects with mild to moderate Alzheimer’s disease.
Design: Phase 2a extension studies of randomized parent trials were conducted in the United States, European Union, and Japan. Methods: Four immunizations of ACC-001 were administered at the same 3 dose levels (3, 10, and 30 μg) to subjects randomized in the parent studies; ACC-001 was administered with QS-21 adjuvant. Safety, tolerability, and immunogenicity were assessed during active treatment and 6-month follow-up. Results: ACC-001 + QS-21 was well tolerated in the United States (N=110) and European Union (N=50), and Japan (N=53) extension studies; safety profile was similar to that observed in the parent studies, and no new safety signals were identified. Overall, injection site reactions were the most common adverse event in these studies. Anti-amyloid antibody titers were elicited in all groups, with the highest titers observed in subjects who received ACC-001 + QS-21 in both the parent and extension studies. Conclusions: Long-term exposure to ACC-001 + QS-21 was well tolerated in subjects with Alzheimer’s disease, suggesting that side effects do not pose a principal limitation for anti-amyloid active immunotherapy. The highest anti-amyloid-beta IgG titers are elicited during long-term therapy with ACC-001 + QS-21 compared with other regimens.Export Options
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Cite this article as:
Long-Term Extensions of Randomized Vaccination Trials of ACC-001 and QS-21 in Mild to Moderate Alzheimer’s Disease, Current Alzheimer Research 2017; 14 (7) . https://dx.doi.org/10.2174/1567205014666170117101537
DOI https://dx.doi.org/10.2174/1567205014666170117101537 |
Print ISSN 1567-2050 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5828 |
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