Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults ≥50 years of age
Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults ≥50 years of age
复制标题
DOI：
10.1016/j.vaccine.2018.03.012
复制
发表时间：
2018-10-29
期刊：
影响因子：
5.5
通讯作者：
Musey, Luwy K.
中科院分区：
文献类型：
--
作者：
Ermlich, Susan J.;Andrews, Charles P.;Musey, Luwy K.
背景：肺炎球菌病仍然是成人的公共卫生重点。采用13价肺炎球菌结合疫苗（PCV13）中包含的13种血清型和另外2种血清型（22F和33F）的15价肺炎球菌结合疫苗（PCV15）在50岁成人（NCT01513551）中的安全性和免疫原性进行了评估。方法：691名成人接种了一剂PCV15、PCV13或23价肺炎球菌多糖疫苗（PPV23），并进行了14天的安全性随访。血清型特异性IgG几何平均浓度（GMCs）和调理噬细胞活性（OPA）几何平均滴度（GMTs）分别在接种前和接种后1个月测定。结果：不同疫苗接种组的安全性具有可比性。PCV15与PCV13和PPV23在相同血清型中诱导的IgG gmc和OPA GMTs水平相当。血清型特异性抗体在PCV15受体中分别高于PCV13和PPV23（共有7种和12种血清型）；4种血清型和1种血清型分别较低。在PCV15特有的血清型中，PCV15诱导的IgG和OPA抗体高于PCV13或PPV23 （PCV13中没有22F和33F， PPV23中没有6A）。结论：PCV15显示出可接受的安全性，并对疫苗中包含的所有15种血清型诱导IgG和OPA，其水平与PCV13和PPV23与这些疫苗共享血清型的水平相当。研究鉴定：V114-002。(C) 2018 Merck & Co, Inc. (C) 2017 Elsevier Ltd.版权所有。
Background: Pneumococcal disease remains a public health priority in adults. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) containing 13 serotypes included in 13-valent pneumococcal conjugate vaccine (PCV13) plus 2 additional serotypes (22F and 33F) was evaluated in adults >= 50 years old (NCT01513551).Methods: 691 adults received one dose of PCV15, PCV13, or 23-valent pneumococcal polysaccharide vaccine (PPV23) and were followed 14 days for safety. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 1-month postvaccination.Results: Safety profiles were comparable across vaccination groups. PCV15 induced comparable levels of IgG GMCs and OPA GMTs to PCV13 and PPV23 for shared serotypes. Serotype-specific antibodies were numerically higher among recipients of PCV15 than PCV13 and PPV23 for 7 and 12 shared serotypes, respectively; and lower for 4 and 1 serotype(s), respectively. PCV15 induced higher IgG and OPA antibodies than PCV13 or PPV23 for serotypes unique to PCV15 (22F and 33F not in PCV13; 6A not in PPV23).Conclusions: PCV15 displayed an acceptable safety profile and induced IgG and OPA to all 15 serotypes included in the vaccine, at levels comparable to PCV13 and PPV23 for shared serotypes with these vaccines.Study identification: V114-002. (C) 2018 Merck & Co., Inc. (C) 2017 Elsevier Ltd. All rights reserved.