Comparison of the immunogenicity and safety of polysaccharide and protein-conjugated pneumococcal vaccines among the elderly aged 80 years or older in Japan: an open-labeled randomized study.
Comparison of the immunogenicity and safety of polysaccharide and protein-conjugated pneumococcal vaccines among the elderly aged 80 years or older in Japan: an open-labeled randomized study.
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日本 80 岁或以上老年人多糖和蛋白结合肺炎球菌疫苗的免疫原性和安全性比较：一项开放标记随机研究。
DOI：
10.1016/j.vaccine.2014.11.023
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发表时间：
2015
期刊：
影响因子：
5.5
通讯作者：
Hasegawa N.
中科院分区：
文献类型：
--
作者：
Namkoong H;Funatsu Y;Oishi K;Akeda Y;Hiraoka R;Takeshita K;Asami T;Yagi K;Kimizuka Y;Ishii M;Tasaka S;Suzuki Y;Iwata S;Betsuyaku T;Hasegawa N.
在80岁或以上老年人中进行了一项开放标签随机研究，以比较多糖（PPV 23）或蛋白结合肺炎球菌疫苗（PCV 7）的免疫原性和安全性。共有105名养老院居民参加了这项研究。我们分析了血清型4、6B、9V、14、18 C、19 F和23 F的表型特异性免疫球蛋白G（IgG）的几何平均浓度（GMC）和调理指数（OI）的几何平均滴度（GMT）。对于评价的所有7种血清型，接种后1个月，两组中血清型特异性IgG的GMC和OI的GMT均显著增加。在PCV 7组中，与PPV 23组相比，血清型为4、9V、18 C和23 F的研究受试者的血清型特异性IgG和OI均出现统计学显著性升高。两种疫苗均耐受，未发生任何严重不良事件，两组间未观察到全身不良事件的差异，尽管PCV 7组中发红和局部肿胀等不良反应更常见。我们的数据表明，与PPV 23组相比，PCV 7组中病毒型特异性IgG的GMC和OI的GMT更高。我们的研究还证实了PCV 7和PPV 23疫苗在80岁或以上老年人中的安全性。
An open-labeled randomized study was conducted to compare the immunogenicity and safety of polysaccharide (PPV23) or protein-conjugated pneumococcal vaccine (PCV7) among the elderly aged 80 years or older. A total of 105 nursing home residents were enrolled in this study. We analyzed the geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) and the geometric mean titer (GMT) of the opsonization index (OI) for serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. The GMCs of serotype-specific IgG and the GMTs of the OI significantly increased one month after vaccination in both groups for all seven serotypes evaluated. In the PCV7 group, study subjects with serotypes 4, 9V, 18C, and 23F exhibited statistically significant elevations in both serotype-specific IgGs and OIs compared to those of the PPV23 group. Both vaccines were tolerated without any severe adverse events, and no differences in systemic adverse events were observed between the two groups, although adverse reactions such as redness and localized swelling were more common in the PCV7 group. Our data demonstrated that the GMCs of serotype-specific IgG and the GMTs of the OI were higher in the PCV7 group compared to those in the PPV23 group. Our study also confirmed the safety of both the PCV7 and PPV23 vaccines in elderly people aged 80 years or older.