Genetic stability of live, cold-adapted influenza virus components of the FluMist®/CAIV-T vaccine throughout the manufacturing process

Genetic stability of live, cold-adapted influenza virus components of the FluMist®/CAIV-T vaccine throughout the manufacturing process
复制标题

DOI:
10.1016/j.vaccine.2005.11.007
复制
发表时间:
2006-03-15
期刊:
影响因子:
5.5
通讯作者:
Udem, SA
Udem, SA
中科院分区:
医学3区
文献类型:
--
作者:
Buonagurio, DA;Bechert, TM;Udem, SA

文献摘要

被引文献

相似文献

fluumist (R)是最近批准用于鼻内给药的三价减毒活疫苗(LAIV)。为了证明LAW疫苗病毒和正在开发的类似疫苗(CAIV-T)在制造过程中的遗传稳定性,在多个制造阶段确定了四种a型流感病毒和五种B型流感病毒的全基因组一致性序列。在病毒制造中间体中保留了关键的冷适应(ca)、温度敏感(ts)和减毒(att)突变。此外,同一菌株的所有疫苗中间产物序列一致。与野生型亲本相比,在疫苗病毒及其共同祖主供体病毒(MDV)的共享基因片段中发现了微小的序列差异,并且一些血凝素(HA)和神经氨酸酶(NA)基因含有核苷酸差异。尽管如此,所有疫苗病毒都保留了ca、ts和att表型。因此,在制造LAW/ cav - t疫苗期间,疫苗病毒的遗传和表型稳定性得以保持。(c) 2005 Elsevier Ltd版权所有。
FluMist (R) is a live-attenuated, trivalent influenza vaccine (LAIV) recently approved for intranasal administration. To demonstrate genetic stability during manufacture of the vaccine viruses in LAW and a similar vaccine in development (CAIV-T), full genome consensus sequences were determined at multiple manufacturing stages for four influenza type A and five type B strains. The critical cold-adapted (ca), temperature-sensitive (ts) and attenuated (att) mutations were preserved in the virus manufacturing intermediates. Moreover, sequence identity was observed for all vaccine intermediates of the same strain. Minor sequence differences were noted in the shared gene segments of the vaccine viruses and their common progenitor master donor virus (MDV) and several of the hemagglutinin (HA) and neuraminidase (NA) genes contained nucleotide differences when compared to the wild-type parent. Nonetheless, all vaccine viruses retained the ca, ts, and att phenotypes. Thus, genetic and phenotypic stability of the vaccine viruses is maintained during the manufacture of LAW/CAIV-T vaccines. (c) 2005 Elsevier Ltd. All rights reserved.