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首页> 外文期刊>Human vaccines & immunotherapeutics. >Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults A randomized open-label trial
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Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults A randomized open-label trial

机译：含和不含磷酸铝的13价肺炎球菌结合疫苗制剂的安全性和免疫原性以及23价肺炎球菌多糖疫苗选择制剂在老年人中的比较一项随机开放标签试验

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This randomized open-label trial was designed to provide preliminary immunogenicity and safety data to support development of the pediatric 13-valent pneumococcal conjugate vaccine (PCV13) for adults. The aims were to: identify an age-appropriate PCV13 formulation, i.e., with (n = 309) or without (n = 304) aluminum phosphate (AlPO4); compare the selected PCV13 formulation (n = 309) with 23-valent pneumococcal polysaccharide vaccine (PPSV23; n = 301); and, together with an extension study, assess sequential use of pneumococcal vaccines at 1-year intervals in adults aged >= 65 years (n = 105) not pre-vaccinated with PPSV23. Immune responses were measured by ELISA and opsonophagocytic activity assays 1 month postvaccination. Immunoglobulin G responses elicited by PCV13 with AlPO4 and PCV13 without AlPO4 were similar for the majority, and noninferior for all PCV13 serotypes. PCV13 with AlPO4 was generally more reactogenic, with reactions mainly mild or moderate. Thus, PCV13 with AlPO4 (hereafter PCV13) became the selected formulation. Immune responses to PCV13 were noninferior for all but one serotype and for most PCV13 serotypes superior to PPSV23. Vaccine sequence assessments showed that for PCV13/PPSV23, the initial PCV13 dose generally enhanced responses to a subsequent PPSV23 dose, compared with PPSV23 alone. For PCV13/PCV13, a second dose did not enhance the first dose response when given after 1 year. For PCV13/PPSV23/PCV13, priming with PCV13 (vaccination 1) did not protect against lower responses induced by PPSV23 to subsequent PCV13 (vaccination 3). In conclusion, the pediatric PCV13 formulation with AlPO4 is well tolerated and immunogenic in adults, is generally more immunogenic than PPSV23, and subsequent vaccination with PPSV23 is possible if required.
机译：这项随机开放标签试验旨在提供初步的免疫原性和安全性数据，以支持开发成人用的儿科13价肺炎球菌结合疫苗（PCV13）。目的是：确定适合年龄的PCV13配方，即使用（n = 309）或不使用（n = 304）磷酸铝（AlPO4）;比较所选的PCV13制剂（n = 309）与23价肺炎球菌多糖疫苗（PPSV23; n = 301）;并与一项扩展研究一起，评估未接种PPSV23的65岁以上（n = 105）成年人每隔1年间隔使用一次肺炎球菌疫苗。免疫后1个月通过ELISA和调理吞噬活性测定法测量免疫应答。对于大多数PCV13血清型，由PCV13结合AlPO4引起的免疫球蛋白G反应和没有AlPO4的PCV13引起的免疫球蛋白G反应大多数相似，且不逊于所有PCV13血清型。带有AlPO4的PCV13通常更具反应原性，反应主要是轻度或中度。因此，具有AlPO 4的PCV13（以下称为PCV13）成为选择的制剂。除一种血清型外，对PCV13的免疫反应均不逊色，并且大多数PCV13血清型均优于PPSV23。疫苗序列评估显示，与单独使用PPSV23相比，对于PCV13 / PPSV23，初始PCV13剂量通常增强了对后续PPSV23剂量的反应。对于PCV13 / PCV13，一年后再给予第二剂并不能增强第一剂反应。对于PCV13 / PPSV23 / PCV13，用PCV13引发（疫苗1）不能抵抗PPS​​V23对随后的PCV13（疫苗3）诱导的较低应答。总之，带AlPO4的小儿PCV13制剂在成人中具有良好的耐受性和免疫原性，通常比PPSV23具有更高的免疫原性，如果需要，可以随后接种PPSV23。

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