Randomized clinical trial of a single versus a double dose of 13-valent pneumococcal conjugate vaccine in adults 55 through 74 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Randomized clinical trial of a single versus a double dose of 13-valent pneumococcal conjugate vaccine in adults 55 through 74 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
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DOI：
10.1016/j.vaccine.2017.12.061
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发表时间：
2018-01-29
期刊：
影响因子：
5.5
通讯作者：
Nahm, Moon H.
中科院分区：
文献类型：
--
作者：
Jackson, Lisa A.;El Sahly, Hana M.;Nahm, Moon H.
简介：在老年人中，预先接种23价肺炎球菌多糖疫苗（PPSV23）会减弱随后接种13价肺炎球菌结合疫苗（PCV 13）的调理吞噬抗体（OPA）反应。为了确定更高剂量的PCV 13是否可以减轻55至74岁成人的这种效应，我们比较了先前接种PSV 23的人对双倍剂量PCV 13的OPA应答与先前接种疫苗的人对单剂量PCV 13的应答，以及PSV 23未接种的人对单剂量PCV 13的应答。既往接种PPSV23的受试者被随机分配接受单次注射或两次同时注射0.5 mL PCV 13。初次受试者接受0.5 mL PCV 13的单次注射。在第29天和第181天采集的样本中评估了对12种PCV 13血清型的血清型特异性OPA应答。研究组间OPA滴度的比较基于对数几何平均值比的95%置信区间的下限，以定义优效性（>1）和非劣效性（>0.5）。在第29天，先前接种疫苗的受试者（n = 284）对一剂OPA的反应与未接种疫苗的受试者（n = 311）对一剂OPA的反应达到了非免疫的阈值。12种血清型中仅3种为劣效性。在既往接种疫苗的受试者中，双倍剂量（n = 288）与单次剂量相比的应答符合7种血清型的优效性阈值。在以前接种过疫苗的受试者与一个单一的剂量在天真的受试者的反应达到了阈值的非劣效性为9 serotypes.Conclusions：有一个剂量反应PCV 13在老年人和较高的反应，以在以前接种过疫苗的成年人的两倍剂量是非劣效于一个单一的剂量在天真的成年人为9的12个PCV 13血清型评价。(C)2018爱思唯尔有限公司版权所有
Introduction: In older adults, prior administration of 23-valent pneumococcal polysaccharide vaccine (PPSV23) blunts the opsonophagocytic antibody (OPA) response to subsequent administration of 13-valent pneumococcal conjugate vaccine (PCV13). To determine whether a higher dose of PCV13 could mitigate this effect in adults 55 through 74 years of age, we compared OPA responses to a double dose of PCV13 in persons previously vaccinated with PPSV23 with responses to a single dose of PCV13 in previously vaccinated persons, and with a single dose in PPSV23 naive persons.Methods: Subjects previously vaccinated with PPSV23 were randomly assigned to receive either a single injection or two concurrent injections of 0.5 mL PCV13. Naive subjects received a single injection of 0.5 mL PCV13. Serotype-specific OPA responses to 12 of the PCV13 serotypes were assessed on samples collected on Day 29 and Day 181. Comparisons of the OPA titers between study groups were based on the lower bound of the 95% confidence interval of the log geometric mean ratio to define superiority (>1) and non-inferiority (>0.5).Results: At Day 29, the OPA responses to one dose in previously vaccinated (n = 284) versus one dose in naive subjects (n = 311) achieved the threshold for non-inferiority for only 3 of the 12 serotypes. In previously vaccinated subjects, responses to a double dose (n = 288) versus a single dose met the threshold for superiority for 7 serotypes. The responses to a double dose in previously vaccinated subjects versus a single dose in naive subjects met the threshold for non-inferiority for 9 serotypes.Conclusions: There is a dose response to PCV13 in older adults and the higher response to a double dose in previously vaccinated adults is non-inferior to that of a single dose in naive adults for 9 of the 12 PCV13 serotypes evaluated. (C) 2018 Elsevier Ltd. All rights reserved.