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首页> 外文期刊>Pediatric drugs >10-Valent Pneumococcal Non-Typeable Haemophilus influenzae Protein D-Conjugate Vaccine: A Review in Infants and Children
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10-Valent Pneumococcal Non-Typeable Haemophilus influenzae Protein D-Conjugate Vaccine: A Review in Infants and Children

机译：10价肺炎球菌非分型流感嗜血杆菌蛋白D结合疫苗：婴儿和儿童中的审查。

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摘要

The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) (Synflorix (TM)) includes ten serotype-specific polysaccharides of Streptococcus pneumoniae, eight of which are conjugated individually to a nonlipidated cell-surface lipoprotein (protein D) of non-typeable H. influenzae and two of which are conjugated to nontoxic tetanus or diphtheria toxoid carrier proteins. This article provides an overview of the well-established immunogenicity of PHiD-CV, including functional immune responses and immunologic memory, as well as immune responses in preterm infants and HIV-infected children. It also includes a brief discussion of cross-protection against vaccine-related serotypes (6A and 19A) and focuses on labelling in the EU, where PHiD-CV is approved for active immunization against invasive disease, pneumonia, and acute otitis media (AOM) caused by S. pneumoniae in infants and young children up to 5 years of age. Evidence of the protective efficacy and effectiveness of PHiD-CV against pneumococcal diseases is available from several studies, including the randomized, double-blind trials COMPAS (Clinical Otitis Media and Pneumonia Study) and FinIP (Finnish Invasive Pneumococcal disease), as well as postmarketing studies from various countries. As would be expected, protection against pneumonia or AOM is substantially lower than that against invasive pneumococcal disease, as many micro-organisms other than pneumococcal vaccine serotypes can cause pneumonia and AOM, thereby limiting the overall protection of PHiD-CV against these diseases. PHiD-CV has a safety and reactogenicity profile similar to that of other pneumococcal conjugate vaccines.
机译：10价肺炎球菌不可分型流感嗜血杆菌蛋白D结合疫苗（PHiD-CV）（Synflorix（TM））包含十种肺炎链球菌血清型特异性多糖，其中八种分别与非脂化细胞表面脂蛋白结合（蛋白D）是不可分型的流感嗜血杆菌，其中两个与无毒破伤风或白喉类毒素载体蛋白缀合。本文概述了已确立的PHiD-CV的免疫原性，包括功能性免疫应答和免疫记忆，以及早产儿和HIV感染儿童的免疫应答。它还简要讨论了针对疫苗相关血清型的交叉保护（6A和19A），并重点关注欧盟的标签，欧盟已批准PHiD-CV进行针对侵袭性疾病，肺炎和急性中耳炎（AOM）的主动免疫由肺炎链球菌引起的5岁以下婴幼儿。 PHiD-CV对肺炎球菌疾病的保护功效和有效性的证据可从几项研究中获得，包括随机，双盲试验COMPAS（临床中耳炎和肺炎研究）和FinIP（芬兰侵袭性肺炎球菌疾病）以及上市后来自不同国家的研究。可以预见，针对肺炎或AOM的保护作用远低于针对侵袭性肺炎球菌的保护作用，因为除肺炎球菌疫苗血清型以外的许多微生物都可能引起肺炎和AOM，从而限制了PHiD-CV对这些疾病的总体保护。 PHiD-CV的安全性和反应原性与其他肺炎球菌结合疫苗相似。

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