Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults.
Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults.
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DOI：
10.1177/2051013615595595
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发表时间：
2015-07-01
期刊：
影响因子：
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通讯作者：
Dunkle, Lisa
中科院分区：
文献类型：
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作者：
Cox, Manon M J;Izikson, Ruvim;Dunkle, Lisa
Flublok是美国食品和药物管理局批准的第一种重组血凝素（HA）疫苗，用于预防18岁及以上成人的流感。使用杆状病毒表达系统技术在昆虫细胞培养物中产生的HA蛋白是野生型循环流感病毒HA的精确类似物。通用HA生产工艺已成功扩展至21，000 L，有助于快速输送大量剂量。本综述讨论了来自五项关键临床研究的免疫原性、疗效和安全性数据，这些研究用于支持美国18岁及以上成人使用三价Flublok的许可。试验数据表明，Flublok中较高的抗原含量可改善免疫原性。数据进一步表明，与标准灭活流感疫苗相比，尽管存在更多抗原（统计学显著性），但有效性提高，局部反应原性略低。Flublok流感疫苗可包括设计用于模拟流感病毒“漂移”的HA，因为预测抗原漂移的过程正在进行，并且至少可解决晚出现的流感病毒。后者的实施需要监管机构的支持。
Flublok is the first recombinant hemagglutinin (HA) vaccine licensed by the US Food and Drugs Administration for the prevention of influenza in adults aged 18 and older. The HA proteins produced in insect cell culture using the baculovirus expression system technology are exact analogues of wild type circulating influenza virus HAs. The universal HA manufacturing process that has been successfully scaled to the 21,000L contributes to rapid delivery of a substantial number of doses. This review discusses the immunogenicity, efficacy and safety data from five pivotal clinical studies used to support licensure of trivalent Flublok for adults 18 years of age and older in the United States. The trial data demonstrate that the higher antigen content in Flublok results in improved immunogenicity. Data further suggest improved efficacy and a slightly lower local reactogenicity compared with standard inactivated influenza vaccine, despite the presence of more antigen (statistically significant). Flublok influenza vaccine can include HAs designed to mimic 'drift' in influenza viruses as the process of predicting antigenic drift advances and, at a minimum, could address late appearing influenza viruses. The implementation of the latter will require support from regulatory authorities.