一项评估V116在50岁及以上有肺炎球菌疫苗接种史的成年人中的安全性、耐受性和免疫原性的3期临床研究（STRIDE-6）。
A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6).
作者信息
Scott Paul, Haranaka Miwa, Choi Jung Hyun, Stacey Helen, Dionne Marc, Greenberg David, Grijalva Carlos G, Orenstein Walter A, Fernsler Doreen, Gallagher Nancy, Zeng Tiantian, Li Jianing, Platt Heather L
机构信息
Merck & Co., Inc., Rahway, New Jersey, USA.
SOUSEIKAI PS Clinic, Fukuoka, Japan.
出版信息
Clin Infect Dis. 2024 Dec 17;79(6):1366-1374. doi: 10.1093/cid/ciae383.
BACKGROUND
Pneumococcal diseases cause considerable morbidity and mortality in adults. V116 is an investigational 21-valent pneumococcal conjugate vaccine (PCV) specifically designed to protect adults from pneumococcal serotypes responsible for the majority of residual pneumococcal diseases. This phase 3 study evaluated safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-experienced adults aged ≥50 years.
METHODS
A total of 717 adults were enrolled to receive a single dose of pneumococcal vaccine as follows: cohort 1 (n = 350) previously received 23-valent pneumococcal polysaccharide vaccine (PPSV23) and were randomized 2:1 to receive V116 or PCV15, respectively; cohort 2 (n = 261) previously received PCV13 and were randomized 2:1 to receive V116 or PPSV23, respectively; cohort 3 (n = 106) previously received PPSV23 + PCV13, PCV13 + PPSV23, PCV15 + PPSV23, or PCV15 and all received open-label V116. Immunogenicity was evaluated 30 days postvaccination using opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) for all V116 serotypes. Safety was evaluated as the proportion of participants with adverse events (AEs).
RESULTS
V116 was immunogenic across all 3 cohorts as assessed by serotype-specific OPA GMTs and IgG GMCs postvaccination for all 21 serotypes. V116 elicited comparable immune responses to serotypes shared with PCV15 (cohort 1) or PPSV23 (cohort 2), and higher immune responses to serotypes unique to V116. The proportions of participants with solicited AEs were generally comparable across cohorts.
CONCLUSIONS
V116 is well tolerated with a safety profile comparable to currently licensed pneumococcal vaccines and generates IgG and functional immune responses to all V116 serotypes, regardless of prior pneumococcal vaccine received.
CLINICAL TRIALS REGISTRATION
NCT05420961; EudraCT 2021-006679-41.
背景
肺炎球菌疾病在成人中导致相当高的发病率和死亡率。V116是一种正在研究的21价肺炎球菌结合疫苗（PCV），专门设计用于保护成人免受导致大多数残留肺炎球菌疾病的肺炎球菌血清型感染。这项3期研究评估了V116在年龄≥50岁、有肺炎球菌疫苗接种史的成人中的安全性、耐受性和免疫原性。
方法
共纳入717名成人接受单剂量肺炎球菌疫苗，具体如下：队列1（n = 350）先前接受过23价肺炎球菌多糖疫苗（PPSV23），并按2:1随机分组，分别接受V116或PCV15；队列2（n = 261）先前接受过PCV13，并按2:1随机分组，分别接受V116或PPSV23；队列3（n = 106）先前接受过PPSV23 + PCV13、PCV13 + PPSV23、PCV15 + PPSV23或PCV15，均接受开放标签的V116。在接种疫苗后30天，使用所有V116血清型的调理吞噬活性（OPA）几何平均滴度（GMT）和免疫球蛋白G（IgG）几何平均浓度（GMC）评估免疫原性。将不良事件（AE）参与者的比例作为安全性评估指标。
结果
通过接种疫苗后所有21种血清型的血清型特异性OPA GMT和IgG GMC评估，V116在所有3个队列中均具有免疫原性。V116对与PCV15（队列1）或PPSV23（队列2）共有的血清型引发了相当的免疫反应，对V116特有的血清型引发了更高的免疫反应。各队列中出现预期AE的参与者比例总体相当。
结论
V116耐受性良好，安全性与目前已获许可的肺炎球菌疫苗相当，并且无论先前接受过何种肺炎球菌疫苗，均能对所有V116血清型产生IgG和功能性免疫反应。
临床试验注册
NCT05420961；EudraCT 2021-006679-41。
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