A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE)-猫眼课题宝

DOI：

10.1016/j.vaccine.2021.08.049

发表时间：

2021-12-10

期刊：

VACCINE

影响因子：

5.5

通讯作者：

中科院分区：

医学3区

文献类型：

作者：

Platt, Heather L.;Cardona, Jose F.;Buchwald, Ulrike K.

背景：肺炎球菌结合疫苗(PCV)极大地降低了肺炎球菌疾病的发病率，但由于非疫苗血清型(STS)引起的疾病增加，仍未满足医疗需求。V114(VAXNEUVANCETM，Merck Sharp&Dohme Corp.，Merck&Co.，Inc.，Kenilworth，NJ，USA)是一种15价PCV，包含许可PCV13中的13个血清型和2个额外的血清型(22F、33F)，这对肺炎球菌疾病的负担有很大贡献。这项3期试验在50岁的成年人中比较了V114和PCV13的安全性、耐受性和免疫原性。方法：成人被随机分为1：1接受V114或PCV13单剂注射；随机按年龄分层(50-年龄，65-74岁，75岁)。接种后收集不良事件(AEs)。在免疫前和免疫后30天(第30天)分别检测血清特异性吞噬细胞活性(OPA)和免疫球蛋白G(Ig G)抗体。主要目标包括评估V114与PCV13对于13个共同的血清型的非劣性，以及V114相对于PCV13对于两个独特的血清型的优势。对于共享的3型血清，V114相对于PCV13的优越性被评估为次要目标。结果：总共有1202名参与者接种了疫苗(V114N=602，PCV13N=600)。两组中最常见的不良反应是注射部位疼痛、疲劳和肌肉疼痛。与PCV13相比，在13个共享的血清型中，V114符合非劣势标准(在第30天，OPA几何平均滴度比率[V114/PCV13]的非劣势幅度为2倍)，而对于2个独特的血清型，V114满足优势(在第30天，OPA几何平均滴度比率[V114/PCV13]的超优幅度为2倍，患有&GT的参与者比例差异的超优势幅度为0.10；从预防接种到第30天，V114/PCV13上升4倍)。与3型PCV13相比，V114符合优势标准(基于OPA GMT比率的超级优势优势1.2[V114/PCV13]，以及具有4倍增长的参与者比例差异的优势优势0)。[NCT03950622，EudraCT#2018004316-22，JAPIC-CTI#194845]。CO 2021作者(S)。由爱思唯尔有限公司出版。这是一篇在CC by License(http://creativecommons.org/licenses/by/4.0/).下的开放获取文章

Background: Pneumococcal conjugate vaccines (PCVs) have greatly reduced the incidence of pneumococcal disease, yet unmet medical need remains due to increased disease caused by non-vaccine serotypes (STs). V114 (VAXNEUVANCETM, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA) is a 15-valent PCV containing 13 serotypes in licensed PCV13 and 2 additional serotypes (22F, 33F) which significantly contribute to pneumococcal disease burden. This phase 3 trial compared safety, tolerability, and immunogenicity of V114 to PCV13 in adults >50 years of age. Methods: Adults were randomized 1:1 to receive a single dose of V114 or PCV13; randomization was stratified by age (50-64 years, 65-74 years, and >75 years). Adverse events (AEs) were collected following vaccination. Serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were measured prior to and 30 days after vaccination (Day 30). Primary objectives included assessing noninferiority of V114 to PCV13 for the 13 shared serotypes and superiority of V114 to PCV13 for the two unique serotypes. Superiority of V114 to PCV13 for shared serotype 3 was assessed as a secondary objective. Results: Overall, 1,202 participants were vaccinated (V114 N = 602, PCV13 N = 600). The most commonly reported AEs across both groups were injection-site pain, fatigue, and myalgia. V114 met noninferiority criteria compared to PCV13 for the 13 shared serotypes (using a 2-fold non-inferiority margin for the ratio of OPA geometric mean titers [GMTs] [V114/PCV13] at Day 30) and met superiority for the 2 unique serotypes (using a 2-fold super-superiority margin for the ratio of OPA GMTs [V114/PCV13] at Day 30 and a 0.10 super-superiority margin for the difference in proportions of participants with >4-fold rise from prevaccination to Day 30). V114 met superiority criteria compared to PCV13 for serotype 3 (based on a super-superiority margin of 1.2 for the ratio of the OPA GMTs [V114/PCV13] and a superiority margin of 0 for the difference in proportions of participants with >4-fold rise). [NCT03950622, EudraCT#2018004316-22, Japic-CTI#194845]. CO 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE)

文献摘要

被引文献

相似文献