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10 价肺炎球菌结合疫苗(PHiD-CV)的有效性和影响:临床试验和上市后经验回顾。

Effectiveness and impact of the 10-valent pneumococcal conjugate vaccine, PHiD-CV: review of clinical trials and post-marketing experience.

机构信息

a GSK , Wavre , Belgium.

b Maxwell Finland Laboratory for Infectious Diseases , Boston University , Boston , MA , USA.

出版信息

Expert Rev Vaccines. 2018 Sep;17(9):797-818. doi: 10.1080/14760584.2018.1516551.

Abstract

INTRODUCTION

Pneumococcal diseases (including septicemia, meningitis, pneumonia, and upper respiratory infections) constitute a major public health problem. The World Health Organization recommends pneumococcal conjugate vaccine immunization of young children worldwide.

AREAS COVERED

We reviewed evidence on the effects of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV), which is used in childhood immunization programs in over 45 countries or regions. The effectiveness of PHiD-CV against invasive pneumococcal disease (IPD), pneumonia, and acute otitis media was assessed. We also present its effect on pneumococcal nasopharyngeal carriage (NPC) and indirect effects (herd protection) among unvaccinated individuals.

EXPERT COMMENTARY

Results from randomized, double-blind trials and post-marketing studies in various countries provide evidence of the protective efficacy, effectiveness, and impact of PHiD-CV against pneumococcal diseases. Data from different geographic locations also show reductions in NPC of vaccine pneumococcal serotypes, laying the foundation for indirect protection against pneumococcal disease. In countries where PHiD-CV is included in childhood immunization programs, there are signs of herd protection for vaccine serotypes among unvaccinated individuals. Although increases in non-vaccine serotype IPD and NPC rates were observed, there was an overall reduction of pneumococcal disease.

摘要

简介

肺炎球菌疾病(包括败血症、脑膜炎、肺炎和上呼吸道感染)构成了一个主要的公共卫生问题。世界卫生组织建议在全球范围内为儿童接种肺炎球菌结合疫苗。

涵盖领域

我们回顾了关于 10 价肺炎球菌型别不可分型流感嗜血杆菌蛋白 D 结合疫苗(PHiD-CV)的效果的证据,该疫苗已在 45 个以上国家或地区的儿童免疫规划中使用。评估了 PHiD-CV 对侵袭性肺炎球菌病(IPD)、肺炎和急性中耳炎的效果。我们还介绍了其对肺炎球菌鼻咽携带(NPC)和未接种人群的间接效应(群体保护)的影响。

专家评论

来自不同国家的随机、双盲试验和上市后研究的结果提供了 PHiD-CV 预防肺炎球菌病的保护效力、效果和影响的证据。来自不同地理位置的数据还显示疫苗血清型 NPC 的减少,为针对肺炎球菌病的间接保护奠定了基础。在将 PHiD-CV 纳入儿童免疫规划的国家,未接种人群中疫苗血清型出现了群体保护迹象。虽然观察到非疫苗血清型 IPD 和 NPC 发生率增加,但肺炎球菌病的总体发病率有所下降。

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