Division of Virology, National Institute for Biological Standards and Control, Health Protection Agency, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, UK.
Vaccine. 2011 Sep 2;29(38):6520-6. doi: 10.1016/j.vaccine.2011.07.007. Epub 2011 Jul 19.
Current HPV vaccines and vaccine candidates are based on recombinant virus capsid proteins, so called virus-like particles (VLPs). Standardisation of assays for HPV capsid antibody will assist with epidemiology studies and future vaccine development. A World Health Organization international collaborative study was undertaken to assess the suitability of a freeze-dried serum, obtained from women naturally infected with HPV 16 and reactive against HPV 16 only, to serve as the International Standard for antibodies to HPV 16 in immunoassays and pseudovirion neutralisation assays. Eleven laboratories from nine countries participated in the collaborative study in which the candidate (NIBSC code 05/134) was assayed alongside samples from both vaccinees and naturally infected individuals. 05/134 had titres which were comparable to those obtained with serum from a naturally infected individual. Overall the variation between laboratories is similar to that observed in the previous study for samples from naturally infected individuals although slightly wider for sera from vaccinees. 05/134 has been established by the WHO Expert Committee on Biological Standardization as the 1st International Standard for antibodies to HPV 16, human serum, with an assigned potency of 5IUper ampoule.
目前的 HPV 疫苗和候选疫苗基于重组病毒衣壳蛋白，即所谓的病毒样颗粒（VLPs）。HPV 衣壳抗体检测方法的标准化将有助于流行病学研究和未来疫苗的开发。世界卫生组织（WHO）开展了一项国际合作研究，以评估一种冻干血清（从自然感染 HPV 16 并仅对 HPV 16 产生反应的女性中获得）是否适合作为免疫测定和假病毒中和测定中 HPV 16 抗体的国际标准。来自九个国家的 11 个实验室参加了这项合作研究，对候选标准品（NIBSC 编码 05/134）与疫苗接种者和自然感染者的样本一起进行了检测。05/134 的效价与从自然感染者血清中获得的效价相当。总体而言，实验室之间的差异与之前对自然感染者样本的研究中观察到的相似，尽管疫苗接种者血清的差异略大。05/134 已被世界卫生组织生物标准化专家委员会确认为 HPV 16 人血清第 1 类国际标准品，其效价为每支安瓿 5IU。
