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首页> 外文期刊>Vaccine >Advax (TM), a novel microcrystalline polysaccharide particle engineered from delta inulin, provides robust adjuvant potency together with tolerability and safety
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Advax (TM), a novel microcrystalline polysaccharide particle engineered from delta inulin, provides robust adjuvant potency together with tolerability and safety

机译：Advax（TM）是一种由δ菊粉制成的新型微晶多糖颗粒，具有强大的佐剂效力以及耐受性和安全性

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摘要

There is an ongoing need for new adjuvants to facilitate development of vaccines against HIV, tuberculosis, malaria and cancer, amongst many others. Unfortunately, the most potent adjuvants are often associated with toxicity and safety issues. Inulin, a plant-derived polysaccharide, has no immunological activity in its native soluble form but when crystallized into a stable microcrystalline particulate from (delta inulin) acquires potent adjuvant activity. Delta inulin has been shown to enhance humoral and cellular immune responses against a broad range of co-administered viral, bacterial, parasitic and toxin antigens. Inulin normally crystallizes as large heterogeneous particles with a broad size distribution and variable solubility temperatures. To ensure reproducible delta inulin particles with a consistent size distribution and temperature of solubility, a current Good Manufacturing Practice (cGMP) process was designed to produce Advax (TM) adjuvant. In its cCMP form, Advax (TM) adjuvant has proved successful in human trials of vaccines against seasonal and pandemic influenza, hepatitis B and insect sting anaphylaxis, enhancing antibody and T-cell responses while being safe and well tolerated. Advax (TM) adjuvant represents a novel human adjuvant that enhances both humoral and cellular immunity. This review describes the discovery and development of Advax (TM) adjuvant and research into its unique mechanism of action. (C) 2015 Elsevier Ltd. All rights reserved.
机译：持续需要新的佐剂以促进开发针对HIV，结核，疟疾和癌症等的疫苗。不幸的是，最有效的佐剂通常与毒性和安全性问题有关。菊粉是一种植物来源的多糖，其天然可溶形式没有免疫活性，但是当从（菊粉）中结晶成稳定的微晶颗粒时，它具有强大的佐剂活性。已显示出增量菊粉可增强针对多种共同施用的病毒，细菌，寄生虫和毒素抗原的体液和细胞免疫应答。菊粉通常会结晶成较大的异质颗粒，具有宽的尺寸分布和可变的溶解温度。为了确保可重复生产的三角菊粉颗粒具有一致的尺寸分布和溶解温度，目前设计了良好生产规范（cGMP）工艺来生产Advax（TM）佐剂。 Advax（TM）佐剂以cCMP形式在针对季节性和大流行性流感，乙型肝炎和昆虫叮咬过敏的疫苗的人体试验中被证明是成功的，可增强抗体和T细胞反应，同时安全且耐受良好。 Advax（TM）佐剂代表一种新型的人类佐剂，可增强体液和细胞免疫。这篇综述描述了Advax（TM）佐剂的发现和开发以及对其独特作用机制的研究。 （C）2015 Elsevier Ltd.保留所有权利。

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