GlaxoSmithKline Biologicals, Av. Fleming 20, Parc de la Noire Epine, 1300 Wavre, Belgium.
Expert Opin Biol Ther. 2011 May;11(5):667-77. doi: 10.1517/14712598.2011.573624. Epub 2011 Apr 4.
Understanding the mode of action of adjuvants is important for the interpretation of clinical studies.
This paper discusses how the results of GSK's clinical studies with an AS04-adjuvanted human papillomavirus (HPV) vaccine are supported by the mode of action of AS04. AS04 and antigens must be injected at the same intramuscular site together or within 24 h of each other. AS04 induces local cytokine production leading to increased recruitment of dendritic cells and monocytes and raised numbers of antigen presenting cells in the draining lymph node. The localized and transient nature of the innate immune response supports the acceptable safety profile observed in clinical studies. The readers will gain a comprehensive understanding of the mode of action of AS04 and how it relates to results of clinical studies.
The AS04-adjuvanted HPV vaccine has an acceptable safety profile and induces an enhanced and sustained immune response and high protection against HPV types 16/18. Cross-protection against oncogenic HPV types 31/33/45 not contained in the vaccine is also observed. The mode of action of AS04 supports the clinical profile of the AS04-adjuvanted HPV vaccine.
了解佐剂的作用模式对于解释临床研究结果非常重要。
本文讨论了葛兰素史克（GSK）使用 AS04 佐剂的人乳头瘤病毒（HPV）疫苗的临床研究结果如何得到 AS04 作用模式的支持。AS04 和抗原必须在同一肌肉内部位同时注射，或在彼此 24 小时内注射。AS04 诱导局部细胞因子产生，导致树突状细胞和单核细胞的募集增加，引流淋巴结中抗原呈递细胞的数量增加。局部和短暂的先天免疫反应支持在临床研究中观察到的可接受的安全性概况。读者将全面了解 AS04 的作用模式以及它与临床研究结果的关系。
AS04 佐剂的 HPV 疫苗具有可接受的安全性概况，可诱导增强和持续的免疫反应，并对 HPV 16/18 型提供高度保护。还观察到针对疫苗中未包含的致癌 HPV 31/33/45 型的交叉保护。AS04 的作用模式支持 AS04 佐剂 HPV 疫苗的临床特征。
