Wan Keiko, Shirakawa Masayoshi, Sawata Miyuki
Japan Development, MSD K.K., Tokyo, Japan.
Japan Development, MSD K.K., Tokyo, Japan.
J Infect Chemother. 2025 Feb;31(2):102539. doi: 10.1016/j.jiac.2024.10.007. Epub 2024 Oct 9.
Subcutaneous (SC) administration is typically used for pediatric inactivated vaccines in Japan, whereas intramuscular (IM) administration is used outside Japan. We previously reported the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), administered subcutaneously and intramuscularly in a Japanese phase 1 study (V114-028). Here, we report secondary descriptive analyses on V114 groups of the study to further assess the safety and immunogenicity profiles of V114 between the administration routes.
A total of 133 healthy Japanese infants were randomized to receive V114-SC (n = 44), V114-IM (n = 45), or PCV13-SC (n = 44) at approximately 3, 4, 5, and 12-15 months of age. Adverse events (AEs) from Days 1-14 post-vaccination and vaccine-related serious AEs from Day 1 to 1-month post-dose 4 were reported. Serotype-specific immunoglobulin G (IgG) responses were measured across the vaccination series.
Proportions of participants with solicited systemic AEs (irritability, somnolence, decreased appetite, and urticaria) and pyrexia were generally comparable between the groups. Compared with V114-SC, patients receiving V114-IM had a lower incidence of irritability and somnolence, and higher incidence of decreased appetite. Proportion of participants with solicited injection-site erythema was lower with V114-IM (82.2%) than V114-SC (100.0%). Those with other solicited injection-site AEs (induration, swelling, and pain) were generally comparable between the groups, with lower observed proportions with V114-IM. Serotype-specific IgG responses were also generally comparable between the groups, including at pre-toddler dose.
These results suggest the utility of IM administration as an option for V114 vaccination in Japanese infants.
在日本，皮下注射（SC）通常用于儿科灭活疫苗，而在日本以外地区则采用肌肉注射（IM）。我们之前在一项日本1期研究（V114-028）中报告了15价肺炎球菌结合疫苗（PCV）V114皮下注射和肌肉注射的安全性和免疫原性。在此，我们报告该研究中V114组的二次描述性分析，以进一步评估不同给药途径下V114的安全性和免疫原性特征。
总共133名健康的日本婴儿被随机分为三组，分别在大约3、4、5和12 - 15月龄时接受V114皮下注射（n = 44）、V114肌肉注射（n = 45）或PCV13皮下注射（n = 44）。报告了接种疫苗后第1 - 14天的不良事件（AE）以及第4剂后第1天至1个月的疫苗相关严重AE。在整个疫苗接种系列中测量了血清型特异性免疫球蛋白G（IgG）反应。
各组间诱发的全身性AE（易激惹、嗜睡、食欲减退和荨麻疹）和发热的参与者比例总体相当。与V114皮下注射组相比，接受V114肌肉注射的患者易激惹和嗜睡的发生率较低，而食欲减退的发生率较高。V114肌肉注射组诱发的注射部位红斑的参与者比例（82.2%）低于V114皮下注射组（100.0%）。其他诱发的注射部位AE（硬结、肿胀和疼痛）在各组间总体相当，V114肌肉注射组观察到的比例较低。血清型特异性IgG反应在各组间也总体相当，包括在幼儿剂量前。
这些结果表明肌肉注射作为日本婴儿V114疫苗接种的一种选择具有实用性。
