Cervarix™, the GSK HPV-16/HPV-18 AS04-adjuvanted cervical cancer vaccine, demonstrates stability upon long-term storage and under simulated cold chain break conditions
Cervarix™, the GSK HPV-16/HPV-18 AS04-adjuvanted cervical cancer vaccine, demonstrates stability upon long-term storage and under simulated cold chain break conditions
复制标题
DOI：
10.4161/hv.8485
复制
发表时间：
2009-07-01
期刊：
影响因子：
--
通讯作者：
Deschamps, Marguerite
中科院分区：
文献类型：
--
作者：
Le Tallec, David;Doucet, Diane;Deschamps, Marguerite
Cervarix（TM）是一种重组人乳头瘤病毒（HPV）-16和-18 L1病毒样颗粒（VLP）AS 04佐剂疫苗，旨在预防由HPV 16和18型引起的宫颈上皮内瘤变和宫颈癌。疫苗在长期储存期间和短暂暴露于超出正常储存范围的温度后的稳定性评估是疫苗质量评价的一个组成部分。这项评估是用在2-8 ℃下储存长达36个月的疫苗样品进行的，有或没有模拟冷链断裂（37 ℃下一周，或25 ℃下两周或四周）。在稳定性指示参数中，沿着评价了抗原性和免疫原性以及L1抗原完整性和铝吸附性。使用差示扫描量热法（DSC）研究VLP在疫苗配制之前和之后以及随时间推移的结构稳定性。Cervarix（TM）在2-8摄氏度下至少稳定三年，冷链断裂的发生没有影响，正如在整个储存期间没有变化的产品特性所示。DSC分析表明，HPV-16和-18 L1蛋白及其相应VLP的结构在整个生产过程中未受到影响。此外，铝吸附的HPV-16和-18 L1 VLP的结构在14个月的测试期内是稳健的。总之，Cervarix（TM）在2-8摄氏度的长期储存中非常稳定，无论是否短暂暴露于更高的温度（高达37摄氏度）。观察到的L1 VLP的坚固结构有助于Cervarix（TM）的优异稳定性。
Cervarix (TM) is a recombinant human papillomavirus ( HPV)-16 and -18 L1 virus-like-particle ( VLP) AS04-adjuvanted vaccine designed to protect against cervical intraepithelial neoplasia and cervical cancer caused by the HPV types 16 and 18. Assessment of the stability of the vaccine during long-term storage and after transient exposure to temperatures out of normal storage range is an integrated part of vaccine quality evaluation. This assessment was done with vaccine samples stored at 2-8 degrees C for up to 36 months, with or without simulated cold chain break ( either one week at 37 degrees C, or two or four weeks at 25 degrees C). Among the stability-indicating parameters, antigenicity and immunogenicity were evaluated along with L1 antigen integrity and adsorption to aluminum. Differential scanning calorimetry ( DSC) was used to investigate the structural stability of the VLPs before and after vaccine formulation and over time. Cervarix (TM) was stable at 2-8 degrees C for at least three years, and the occurrence of cold chain break had no impact, as shown by unchanged product characteristics during the full storage period. DSC analysis demonstrated that the structure of the HPV-16 and -18 L1 proteins and their corresponding VLPs was not affected throughout the manufacturing process. Moreover, the structure of aluminum-adsorbed HPV-16 and -18 L1 VLPs was robust over a 14-month test period. In conclusion, Cervarix (TM) was very stable upon long-term storage at 2-8 degrees C with or without transient exposure to higher temperatures ( up to 37 degrees C). The observed robust structure of the L1 VLPs contributes to the excellent stability of Cervarix (TM).