中国上海60 - 70岁老年人23价肺炎球菌多糖疫苗再接种的免疫原性和安全性研究
Immunogenicity and safety study of 23-valent pneumococcal polysaccharide vaccine revaccination among elderly individuals aged 60-70 years in Shanghai, China.
作者信息
Qiu Jing, Li Zhi, Huang Fang, Huang Zhuoying, Liang Xiufang, Li Juan, Liao Yuting, Guo Xiang, Sun Xiaodong
机构信息
Department of Immunization, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.
Department of Immunization, Yangpu District Center for Disease Control and Prevention, Shanghai, China.
出版信息
Front Immunol. 2025 Jul 17;16:1623611. doi: 10.3389/fimmu.2025.1623611. eCollection 2025.
BACKGROUND
To understand the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in elderly individuals aged 60-70 years in Shanghai after revaccination.
METHODS
A total of 330 elderly people aged 60-70 years were recruited to study the immunogenicity and safety of PPSV23 revaccination. The group with a history of PPSV23 vaccination and an interval of 5 years or more was selected as the revaccination group (n=220), and the group without any pneumococcal vaccine was selected as the first vaccination group (n=110).
RESULTS
In terms of immunogenicity, the GMCs of all serotypes before and after immunization were 1.15-21.57 µg/ml and 1.62-33.19 µg/ml, respectively, in the revaccination group, and the GMCs of all serotypes after immunization were higher than those before immunization (<0.0001). After immunization, the total GMI of antibodies in the revaccination group was lower than that in the first vaccination group [1.62(1.57, 1.67) vs 3.20(2.82, 3.57), <0.0001], and the GMIs of all serotypes in the revaccination group were also lower than those in the first vaccination group [(1.40-1.92) vs (1.82-4.69), <0.0001]. In terms of safety, no serious adverse events occurred during the study and all adverse events that occurred were mild or self-limiting. From 0-30 days after immunization, 7 patients in the revaccination group and 14 patients in the first vaccination group experienced adverse events, with incidence rates of 3.18% and 12.73%, respectively, which were lower in the revaccination group than in the first vaccination group (=0.0008).
CONCLUSIONS
Compared with those before vaccination, the antibody levels of elderly people aged 60-70 years in Shanghai who were inoculated with PPSV23 for 5 years or more tended to increase but were lower than those in the first vaccination group. The safety of revaccination with PPSV23 was favorable.
CLINICAL TRIAL REGISTRATION
http://www.chictr.org.cn, identifier ChiCTR2100042000; http://clinicaltrials.gov, identifier NCT04701788.
背景
了解23价肺炎球菌多糖疫苗在上海60 - 70岁老年人再次接种后的免疫原性和安全性。
方法
共招募330名60 - 70岁老年人，研究23价肺炎球菌多糖疫苗再次接种的免疫原性和安全性。选择有23价肺炎球菌多糖疫苗接种史且间隔5年或更长时间的人群作为再次接种组（n = 220），选择未接种过任何肺炎球菌疫苗的人群作为首次接种组（n = 110）。
结果
在免疫原性方面，再次接种组免疫前后各血清型的几何平均浓度（GMCs）分别为1.15 - 21.57μg/ml和1.62 - 33.19μg/ml，免疫后各血清型的GMCs均高于免疫前（<0.0001）。免疫后，再次接种组抗体的总几何平均滴度（GMI）低于首次接种组[1.62(1.57, 1.67)对3.20(2.82, 3.57)，<0.0001]，再次接种组各血清型的GMI也低于首次接种组[(1.40 - 1.92)对(1.82 - 4.69)，<0.0001]。在安全性方面，研究期间未发生严重不良事件，所有发生的不良事件均为轻度或自限性。免疫后0 - 30天，再次接种组7例患者和首次接种组14例患者发生不良事件，发生率分别为3.18%和12.73%，再次接种组低于首次接种组（P = 0.0008）。
结论
与接种前相比，上海60 - 70岁接种23价肺炎球菌多糖疫苗5年或更长时间的老年人抗体水平有升高趋势，但低于首次接种组。23价肺炎球菌多糖疫苗再次接种的安全性良好。
临床试验注册
http://www.chictr.org.cn，标识符ChiCTR2100042000；http://clinicaltrials.gov，标识符NCT047
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