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首页> 外文期刊>Vaccine >Immunogenicity, efficacy, safety and effectiveness of pneumococcal conjugate vaccines (1998-2006)
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Immunogenicity, efficacy, safety and effectiveness of pneumococcal conjugate vaccines (1998-2006)

机译：肺炎球菌结合疫苗的免疫原性，功效，安全性和有效性（1998-2006年）

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In this paper we present an overview of the literature on efficacy and safety trials of the various pneumococcal conjugate vaccines on the market (PCV7) and in development (PCV9, PCV11 and allegedly PCV10 and PCV13), as well as of observations from post-licensure studies. Seven- (PCV7) and nine-valent PCV (PCV9) are reported to be sufficiently immunogenic after administration of a 3+1 schedule in infants in various RCTs. PncOMPC (PCV7 with a protein of N. meningitidis as a carrier) is less immunogenic, though this may have no repercussions for the protective efficacy against clinical disease. PCV7 is 82-97% efficacious against vaccine serotype (VT) IPD, 90% efficacious against (clinically diagnosed) pneumococcal pneumonia, and, like the 11-valent PCV, 57% efficacious against VT acute otitis media. Naturally, it would be of paramount public health interest if the same levels of efficacy and effectiveness could be achieved with fewer doses. Trials studying 2+1 vaccination schedules for PCV7 and PCV9 generally show that the percentage of infants achieving the protective cut-off set by the World Health Organization (WHO) 1 month after the last priming dose, is comparable to that found at the same time point in studies administering 3+1 schedules. PCVs are generally very well tolerated and safe, also when co-administered with other childhood vaccines. As more and more countries are using these vaccines routinely, post marketing surveillance studies will further establish the safety profile of PCVs.
机译：在本文中，我们概述了市场上（PCV7）和正在开发中（PCV9，PCV11以及据称PCV10和PCV13）的各种肺炎球菌结合疫苗的功效和安全性试验的文献，以及许可后的观察结果学习。据报导，在各种RCT中的婴儿以3 + 1的时间表服用7（PCV7）和9价PCV（PCV9）具有足够的免疫原性。 PncOMPC（以脑膜炎奈瑟氏球菌为载体的PCV7）的免疫原性较低，尽管对临床疾病的保护作用可能没有影响。 PCV7对疫苗血清型（VT）IPD有82-97％的功效，对（临床诊断）肺炎球菌性肺炎有90％的功效，并且像11价PCV一样，对VT急性中耳炎有57％的功效。自然地，如果可以用更少的剂量达到相同水平的功效，则对公共卫生至关重要。研究PCV7和PCV9的2 + 1疫苗接种时间表的试验通常表明，在上一次初次接种剂量后1个月达到世界卫生组织（WHO）设定的保护性临界值的婴儿百分比与同期发现的婴儿相当管理3 + 1时间表的研究中的重点。当与其他儿童疫苗同时使用时，PCV通常具有很好的耐受性和安全性。随着越来越多的国家例行使用这些疫苗，售后监测研究将进一步确定PCV的安全性。

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