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关于预测保护性疫苗效力定义替代血清学检测:脊髓灰质炎病毒疫苗接种

Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: poliovirus vaccination.

作者信息

Sutter R W, Pallansch M A, Sawyer L A, Cochi S L, Hadler S C

机构信息

National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.

出版信息

Ann N Y Acad Sci. 1995 May 31;754:289-99. doi: 10.1111/j.1749-6632.1995.tb44462.x.

DOI:10.1111/j.1749-6632.1995.tb44462.x
PMID:7625665
Abstract

Inactivated and trivalent oral poliovirus vaccines contain either formalin-inactivated or live, attenuated poliovirus, respectively, of the three serotypes. Interference among the three attenuated poliovirus serotypes was minimized with a "balanced-formulation" vaccine, and serologic responses after IPV were optimized by adjusting the antigenic content of each inactivated poliovirus serotype. Seroconversion is dependent on both the relative content as well as the absolute quantity of virus in the vaccine. The "gold standard" method to assess humoral antibody responses following vaccination is the neutralization assay. Any detectable titer of neutralizing antibody against poliovirus is considered protective against clinical paralytic diseases. Recently, standard procedures were adopted for conducting neutralization assays. Efforts are being undertaken now to develop a combined diphtheria and tetanus toxoids and pertussis vaccine and IPV vaccine in the United States using a dual-chambered syringe that mixes the content of both vaccines at the time of injection; this approach is necessary to overcome the potential detrimental effect of thimerosal on IPV (the preservative in DTP). Other vaccines that combine DTP and/or Haemophilus influenzae type b and/or hepatitis B with IPV appear feasible but require further investigation. New combination vaccines should induce similar or superior levels of neutralizing antibody in serum for individual protection against paralytic disease and mucosal immunity that effectively decreases viral replication in the intestine and pharynx for population protection against transmission of poliovirus.

摘要

灭活三价口服脊髓灰质炎疫苗分别含有三种血清型的福尔马林灭活脊髓灰质炎病毒或减毒活脊髓灰质炎病毒。通过“平衡配方”疫苗可将三种减毒脊髓灰质炎病毒血清型之间的干扰降至最低,通过调整每种灭活脊髓灰质炎病毒血清型的抗原含量可优化灭活脊髓灰质炎疫苗(IPV)接种后的血清学反应。血清转化取决于疫苗中病毒的相对含量以及绝对数量。评估接种疫苗后体液抗体反应的“金标准”方法是中和试验。任何可检测到的针对脊髓灰质炎病毒的中和抗体滴度都被认为对临床麻痹性疾病具有保护作用。最近,采用了进行中和试验的标准程序。目前美国正在努力研发一种联合白喉破伤风类毒素和百日咳疫苗以及IPV疫苗,使用双腔注射器在注射时混合两种疫苗的成分;这种方法对于克服硫柳汞对IPV(百白破疫苗中的防腐剂)的潜在有害影响是必要的。其他将百白破和/或b型流感嗜血杆菌和/或乙型肝炎与IPV联合的疫苗似乎可行,但需要进一步研究。新的联合疫苗应在血清中诱导出相似或更高水平的中和抗体,以提供个体对麻痹性疾病的保护,以及诱导黏膜免疫,有效减少肠道和咽部的病毒复制,从而提供群体对脊髓灰质炎病毒传播的保护。

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