背景:患有某些医学和行为因素的成年人患肺炎球菌病(PD)的风险增加。在某些国家/地区,建议对有风险的成年人进行序贯接种13价肺炎球菌结合疫苗(PCV13),然后接种23价肺炎球菌多糖疫苗(PPSV23)。
方法:这项3期试验评估了安全性,耐受性,和顺序施用V114(含有血清型1、3、4、5、6A的15价PCV,6B,7F,9V,14,18C,19A,19F,22F,23F,和33F)或PCV13,6个月后进行PPSV23,年龄在18-49岁的有免疫能力的成年人中有或没有预定义的PD危险因素(NCT03547167)。总的来说,1515名参与者以3:1随机分配接受V114或PCV13,然后接受PPSV23。
结果:给药V114或PCV13以及PPSV23后最常见的不良事件(AE)是注射部位疼痛和疲劳。两组中出现AE的参与者比例相当。V114和PCV13是基于调理吞噬活性(OPA)几何平均滴度(GMT)的免疫原性,对于每种各自疫苗中包含的所有血清型,疫苗接种后30天。OPAGMT对V114中的2种独特血清型在V114组中是稳健的。在两个疫苗接种组中,PPSV23对V114中包含的所有15种血清型均具有免疫原性,包括22F和33F。
结论:V114单独给药或与PPSV23序贯给药对所有15种血清型均具有良好的耐受性和免疫原性,包括PCV13中不包含的免疫功能正常的18-49岁成人,有或没有PD的某些医学或行为风险因素。
背景:NCT03547167和EudraCT2017-004915-38。
BACKGROUND: Adults with certain medical and behavioral factors are at increased risk for pneumococcal disease (PD). Sequential vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for at-risk adults in some countries.
METHODS: This phase 3 trial evaluated the safety, tolerability, and immunogenicity of sequential administration of either
V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 6 months later by PPSV23, in immunocompetent adults aged 18-49 years with or without predefined risk factors for PD (NCT03547167). Overall, 1515 participants were randomized 3:1 to receive either
V114 or PCV13, followed by PPSV23.
RESULTS: Most common solicited adverse events (AEs) following administration of
V114 or PCV13 as well as PPSV23 were injection-site pain and fatigue. The proportion of participants with AEs was comparable in both groups.
V114 and PCV13 were immunogenic based on opsonophagocytic activity (OPA) geometric mean titers (GMTs) 30 days postvaccination for all serotypes contained in each respective vaccine. OPA GMTs to the 2 unique serotypes in
V114 were robust in the
V114 group. PPSV23 was immunogenic for all 15 serotypes contained in V114 in both vaccination groups, including 22F and 33F.
CONCLUSIONS: V114 administered alone or sequentially with PPSV23 is well tolerated and immunogenic for all 15 serotypes, including those not contained in PCV13, in immunocompetent adults aged 18-49 years with or without certain medical or behavioral risk factors for PD.
BACKGROUND: NCT03547167 and EudraCT 2017-004915-38.