肺炎球菌疫苗人血清学评价方法概述  

Overview of human serological evaluation methods for Streptococcus pneumoniae vaccine

作　　者：张珊(综述) 罗树权(审校) ZHANG Shan;LUO Shu-quan(The First Research Department,Lanzhou Institute of Biological Products Co.,Ltd.,Center of Gansu Provincial Vaccine Engineering Research,Lanzhou 730046,Gansu Province,China)

机构地区：[1]兰州生物制品研究所有限责任公司第一研究室、甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2023年第3期96-102,共7页Progress In Microbiology and Immunology

基　　金：“重大新药创制”科技重大专项(2018ZX09738006)。

摘　　要：肺炎链球菌(Streptococcus pneumoniae,简称肺炎球菌)感染是一种引起全球各年龄段人群呼吸系统高发病率及较高死亡率的主要原因之一。目前,为了预防肺炎球菌引起的疾病,已上市2种可预防多种血清型肺炎的多价肺炎球菌疫苗。在评价新研发的肺炎球菌疫苗的保护效果时,疫苗的效力通常取决于接种者疾病发生率的差别。然而,由于疾病的病原学诊断和监测难度大,以及现有疫苗接种在人群中诱导产生的免疫保护力,因此对疾病的保护效果评估存在困难。如果能确定疫苗保护效力的血清学替代指标,将极大地提升新疫苗的研发效率。因此,研究人员开发了针对肺炎球菌疫苗的人血清学评价方法,用酶联免疫吸附试验(enzyme-linked immunosorbent assay,ELISA)和调理吞噬杀菌试验(opsonophagocytic killing assay,OPKA)方法作为该疫苗保护效力的替代指标,并成为其主要评价方法。现就肺炎球菌疫苗人血清学评价方法ELISA和OPKA作一概述。Streptococcus pneumoniae infection is one of the major cause of high morbidity and mortality of respiratory system in people of all ages worldwide.Currently,two polyvalent pneumococcal vaccines are on the market to prevent pneumococcal disease,which can protect against multiple serotypes of pneumonia.In evaluating the protective effect of newly developed pneumococcal vaccines,the effectiveness of the vaccine usually depends on differences in the incidence of disease among those vaccinated.However,due to the difficulty of etiological diagnosis and detection of diseases,and the immune protection induced in the population due to existing vaccination,it is difficult to evaluate the protective effect of diseases.Identifying alternative Serological surrogates of vaccine protective efficacy would greatly improve the efficiency of new vaccine development.Therefore,the human serological evaluation methods for pneumococcal vaccine,enzyme-linked immunosorbent assay and opsonophagocytic bactericidal assay,were developed as alternative surrogates for the protective efficacy of the vaccine and became the main evaluation methods.An overview of the human serological evaluation methods ELISA and OPKA for pneumococcal vaccines is presented.

关 键 词：肺炎链球菌 肺炎球菌结合疫苗 血清学 酶联免疫吸附试验 调理吞噬杀菌试验 评价方法 

分 类 号：R378.1[医药卫生—病原生物学]