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肺炎球菌结合疫苗保护效力血清学替代指标在新疫苗研发中意义

安志杰 李燕 王华庆

安志杰, 李燕, 王华庆. 肺炎球菌结合疫苗保护效力血清学替代指标在新疫苗研发中意义[J]. 中国公共卫生, 2018, 34(11): 1460-1464. doi: 10.11847/zgggws1121521
引用本文: 安志杰, 李燕, 王华庆. 肺炎球菌结合疫苗保护效力血清学替代指标在新疫苗研发中意义[J]. 中国公共卫生, 2018, 34(11): 1460-1464. doi: 10.11847/zgggws1121521
Zhi-jie AN, Yan LI, Hua-qing WANG. Using serological surrogate indicators to evaluate pneumococcal conjugate vaccine efficacy: supporting new vaccine development[J]. Chinese Journal of Public Health, 2018, 34(11): 1460-1464. doi: 10.11847/zgggws1121521
Citation: Zhi-jie AN, Yan LI, Hua-qing WANG. Using serological surrogate indicators to evaluate pneumococcal conjugate vaccine efficacy: supporting new vaccine development[J]. Chinese Journal of Public Health, 2018, 34(11): 1460-1464. doi: 10.11847/zgggws1121521

肺炎球菌结合疫苗保护效力血清学替代指标在新疫苗研发中意义

doi: 10.11847/zgggws1121521
详细信息
    作者简介:

    安志杰(1972 – ),男,黑龙江人,研究员,公共卫生硕士,研究方向:疫苗针对疾病防控、免疫规划策略和政策研究

  • 中图分类号: R378.1+2

Using serological surrogate indicators to evaluate pneumococcal conjugate vaccine efficacy: supporting new vaccine development

  • 摘要: 基于肺炎球菌性疾病在全球范围内具有较高疾病负担的现实,世界卫生组织(WHO)推荐所有国家考虑将肺炎球菌结合疫苗(PCV)纳入本国的免疫规划。然而,由于肺炎球菌性疾病发病率低,病原学诊断和监测难度大,开展疫苗针对疾病的保护效果评估存在诸多困难。如能确定疫苗保护效力的替代指标,将极大地提升新疫苗研发的效率。基于已经上市的7价肺炎球菌结合疫苗(PCV7)临床试验过程中获得的疫苗针对疾病的保护效果和血清学效力的数据,WHO建立了PCV预防侵袭性肺炎球菌疾病(IPD)的抗体保护性阈值,建议将基于酶联免疫吸附试验(ELISA)方法检测的IgG水平达到0.35 μg/mL作为PCV接种后预防IPD的保护性水平,并在新PCV疫苗注册审批时,应用该阈值来评估疫苗针对IPD的保护效果。但该替代指标不能用于评估针对非侵袭性肺炎球菌疾病的保护效果,同时该阈值只适用于人群水平,不能保证在个体水平为预防IPD提供完全保护。
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  • 接收日期:  2018-05-28
  • 刊出日期:  2018-11-01

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