Advax™, a novel microcrystalline polysaccharide particle engineered from delta inulin, provides robust adjuvant potency together with tolerability and safety.
Advax™, a novel microcrystalline polysaccharide particle engineered from delta inulin, provides robust adjuvant potency together with tolerability and safety.
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DOI：
10.1016/j.vaccine.2015.09.030
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发表时间：
2015-11-04
期刊：
影响因子：
5.5
通讯作者：
Cooper PD
中科院分区：
文献类型：
--
作者：
Petrovsky N;Cooper PD
持续需要新的佐剂，以促进针对艾滋病毒、结核病、疟疾和癌症等许多疾病的疫苗的开发。不幸的是，最有效的佐剂往往与毒性和安全问题有关。菊粉是一种植物来源的多糖，其天然可溶性形式没有免疫活性，但当结晶成稳定的微晶颗粒时，具有强大的佐剂活性。Delta菊粉已被证明可以增强体液和细胞免疫反应，对抗广泛的联合注射的病毒、细菌、寄生虫和毒素抗原。菊粉通常结晶为大的非均相颗粒，具有广泛的尺寸分布和可变的溶解温度。为了确保可重复性的三角洲菊粉颗粒具有一致的粒度分布和溶解温度，设计了一种当前良好的制造规范(CGMP)工艺来生产Advax™佐剂。在CCMP形式中，Advax™佐剂已被证明成功地用于季节性和大流行性流感、乙肝和昆虫刺痛过敏的疫苗的人体试验，在安全和耐受性良好的同时增强抗体和T细胞反应。Advax™佐剂代表了一种新型的人类佐剂，可以增强体液和细胞免疫。本文综述了Advax™佐剂的发现、发展及其独特作用机制的研究进展。
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™ adjuvant. In its cCMP form, Advax™ 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™ adjuvant represents a novel human adjuvant that enhances both humoral and cellular immunity. This review describes the discovery and development of Advax™ adjuvant and research into its unique mechanism of action.