Department of Internal Medicine, SOUSEIKAI PS Clinic, Fukuoka, Japan.
Department of Urology, Nishi-Kumamoto Hospital, Souseikai, Kumamoto, Japan.
Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162.
V116 is an investigational 21-valent pneumococcal conjugate vaccine (PCV) to address the burden of residual adult pneumococcal disease after the introduction of pediatric PCVs into national immunization programs (NIPs) and includes serotypes highly prevalent in adult invasive pneumococcal disease (IPD). This Phase I study assessed the safety, tolerability, and immunogenicity of V116 in Japanese adults. Participants ≥20 years of age were randomized to receive a single dose of V116 or 23-valent pneumococcal polysaccharide vaccine (PPSV23) at day 1. Outcomes were solicited injection-site and systemic adverse events (AEs) from day 1 to day 5, vaccine-related serious AEs from day 1 through day 30, and serotype-specific opsonophagocytic antibody (OPA) titers and immunoglobulin G (IgG) concentrations at day 30. Overall, 102 participants were randomized 1:1 to each group. Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE and ≥1 solicited systemic AE. The most common injection-site AEs were injection-site pain (V116: 54.9%; PPSV23: 66.7%) and swelling (V116 and PPSV23: 13.7%), and the most common systemic AEs were myalgia (V116: 17.6%; PPSV23: 19.6%) and fatigue (V116: 13.7%; PPSV23: 9.8%). Solicited AEs were mostly mild and of ≤3 days duration. No vaccine-related serious AEs or deaths were reported. The OPA and IgG findings showed that the immunogenicity of V116 and PPSV23 were comparable for the 12 common serotypes and V116 was more immunogenic for the nine unique serotypes compared with PPSV23. V116 was well tolerated, with a safety profile similar to PPSV23, and induced functional antibodies against all 21 serotypes.
V116 是一种研究性 21 价肺炎球菌结合疫苗（PCV），旨在解决儿童 PCV 纳入国家免疫规划（NIP）后成人肺炎球菌疾病负担问题，包含成人侵袭性肺炎球菌病（IPD）中高度流行的血清型。这项 I 期研究评估了 V116 在日本成年人中的安全性、耐受性和免疫原性。年龄≥20 岁的参与者按 1:1 随机分配，在第 1 天接受 V116 或 23 价肺炎球菌多糖疫苗（PPSV23）单剂接种。从第 1 天到第 5 天，主要终点为征集到的注射部位和全身不良事件（AE），第 1 天至第 30 天报告疫苗相关严重 AE，第 30 天评估血清型特异性调理吞噬抗体（OPA）滴度和免疫球蛋白 G（IgG）浓度。总体而言，102 名参与者随机分为每组各 51 人。接受 V116 和 PPSV23 接种的比例相当，均报告了≥1 例征集到的注射部位 AE 和≥1 例征集到的全身 AE。最常见的注射部位 AE 是注射部位疼痛（V116：54.9%；PPSV23：66.7%）和肿胀（V116 和 PPSV23：13.7%），最常见的全身 AE 是肌痛（V116：17.6%；PPSV23：19.6%）和疲劳（V116：13.7%；PPSV23：9.8%）。征集到的 AE 大多为轻度，持续时间≤3 天。未报告疫苗相关严重 AE 或死亡病例。OPA 和 IgG 结果表明，V116 和 PPSV23 对 12 种常见血清型的免疫原性相当，与 PPSV23 相比，V116 对 9 种独特血清型更具免疫原性。V116 耐受性良好，安全性与 PPSV23 相似，能诱导针对所有 21 种血清型的功能性抗体。
