HPV Serology

人类乳头瘤病毒感染大多是良性的和自限性的，但某些基因类型被认为是高风险和致癌的。在几乎所有的宫颈癌中都发现了HPV，其中HPV16引起了50%，HPV18引起了另外20%。目前，已批准的人乳头状瘤病毒(HPV)疫苗有三种，效果良好，但缺乏对疫苗诱导免疫相关性的描述。其中一种疫苗是二价疫苗(Cervarx，GSK)，第二种是四价疫苗(Gardasil，Merck)，第三种是非价疫苗(Gardasil9)。这三种疫苗都利用基于HPV L1主要衣壳蛋白的病毒样颗粒(VLP)。VLP是通过在酵母或昆虫细胞中表达衣壳蛋白而产生的非感染性蛋白衣壳。重组的L1衣壳蛋白组装成60 nm的HPV VLP。每种疫苗的效力都是用不同的标准进行评估的，这使得疫苗的比较变得困难。也有迹象表明，这些疫苗中的一剂可能与目前使用的三剂方案一样有效，但没有一套血清学标准可用于评估。目前，混合的人血清是最好的标准，并被用来创建一条曲线，从该曲线以任意单位/毫升的单位推断结果。然而，混合的血清是有限的资源，后续的研究需要开发一个新的池，该池是根据先前的池进行校准的，因此作为标准有其局限性。其目标是建立一个实验室，通过开发可供科学界使用的经过验证的试剂和标准，使人乳头瘤病毒(HPV)抗体检测的血清学分析标准化和统一。该实验室将提供符合疫苗开发和实施规定的法规要求的合格和标准化的高通量测试。该实验室将与科学界和监管实体合作，以确定HPV血清学方面未得到满足的需求。

Human Papillomavirus infection is mostly benign and self-limiting, however certain genotypes are considered high risk and oncogenic. HPV has been found in virtually all cervical cancers with HPV 16 causing 50% and HPV 18 another 20%. Currently, there are three licensed human papillomavirus (HPV) vaccines with excellent efficacy, but poorly characterized correlates of vaccine induced immunity. One of the vaccines is bivalent (Cervarix, GSK), the second is quadrivalent (Gardasil, Merck), while the third is nonavalent (Gardasil9). All three vaccines utilize virus like particles (VLPs) based on the L1 major capsid protein from HPV. VLPs are noninfectious protein capsids which can be produced by expressing the capsid protein in yeast or insect cells. The recombinant L1 capsid protein assembles in into the 60-nm HPV VLP. The efficacy of each vaccine has been evaluated with different standards, making comparison of the vaccines difficult. There has also been indication suggesting that one dose of these vaccines may be as efficacious as the three-dose regimen currently in use, however there is no set of serological standards that could be used for evaluation. Currently, pooled human serum serves as the best standard and is used to create a curve from which results are extrapolated in arbitrary Units/ml. However, the pooled serum is a finite resource and subsequent studies require the development of a new pool that is calibrated against the previous pool and therefore has its limitations as a standard. The goal is to establish a laboratory that would standardize and harmonize serological assays for Human Papillomavirus (HPV) antibody testing through development of validated reagents and standards that will be available to the scientific community. The laboratory will provide well qualified and standardized high-throughput testing that adheres to regulatory requirements defined for vaccine development and implementation. The laboratory will work with the scientific community and regulatory entities to identify unmet needs in HPV serology.