Cox Manon M J, Patriarca Peter A, Treanor John
Protein Sciences Corporation, 1000 Research Parkway, Meriden, CT 06450, USA.
Influenza Other Respir Viruses. 2008 Nov;2(6):211-9. doi: 10.1111/j.1750-2659.2008.00053.x.
FluBlok, a recombinant trivalent hemagglutinin (HA) vaccine produced in insect cell culture using the baculovirus expression system, provides an attractive alternative to the current egg-based trivalent inactivated influenza vaccine (TIV) manufacturing process. FluBlok contains three times more HA than TIV and does not contain egg-protein or preservatives. This review discusses the four main clinical studies that were used to support licensure of FluBlok under the 'Accelerated Approval' mechanism in the United States.
FluBlok是一种利用杆状病毒表达系统在昆虫细胞培养中生产的重组三价血凝素(HA)疫苗,为目前基于鸡蛋的三价灭活流感疫苗(TIV)生产工艺提供了一种有吸引力的替代方案。FluBlok含有的HA是TIV的三倍,且不含鸡蛋蛋白或防腐剂。本综述讨论了用于支持FluBlok在美国“加速批准”机制下获得许可的四项主要临床研究。