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免疫原性和安全性的 13 价肺炎球菌结合疫苗与 23 价肺炎球菌多糖疫苗在免疫功能正常的成年人:系统评价和荟萃分析。

Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine compared to 23-valent pneumococcal polysaccharide in immunocompetent adults: A systematic review and meta-analysis.

机构信息

Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada.

Faculty of Medicine, University of British Columbia, Vancouver, Canada.

出版信息

Vaccine. 2019 Feb 14;37(8):1021-1029. doi: 10.1016/j.vaccine.2019.01.014. Epub 2019 Jan 23.

Abstract

BACKGROUND

Despite the use of 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults there is substantial morbidity and mortality in the elderly due to pneumococcal infections. Since 2010, the 13-valent pneumococcal conjugate vaccine (PCV13) is in use for infant immunization programs to reduce rates of pneumococcal disease, but is not routinely used in adults. Recent literature suggests PCV13 may be used in adult vaccination programs as well.

OBJECTIVE

To determine the immunogenicity and safety of PCV13 compared with the PPV23 in adults.

DESIGN

Systematic review and meta-analysis.

SETTING

Randomized controlled trials evaluating immunogenicity of a single dose of PCV13 and PPV23 in adults by the opsonophagocytic assay (OPA) geometric mean titer (GMT) response at 1-month post-vaccination were considered for inclusion.

RESULTS

Five randomized trials were included with 4561 subjects ranging 50-95.5 years, consisting of 51% females. The pooled OPA GMT ratio (GMTR) in the PCV13 arm was significantly higher for 10 of 13 serotypes (1, 4, 5, 6A, 6B, 9V, 18C, 19A, 19F and 23F) compared with the PPV23 arm. Overall, pooled risk ratios (RR) for local and systemic reactions did not differ between PCV13 and PPV23. Pneumococcal naïve subjects experienced significantly higher local reactions in the PCV13 arm compared with the PPV23 arm (RR: 1.15, 95%CI: 1.05-1.26, p = 0.0025).

CONCLUSION

A single dose of PCV13 elicits a better immune response among adults compared with PPV23, while having a similar safety profile to PPV23.

摘要

背景

尽管在成年人中使用了 23 价肺炎球菌多糖疫苗(PPV23),但由于肺炎球菌感染,老年人仍存在大量发病率和死亡率。自 2010 年以来,13 价肺炎球菌结合疫苗(PCV13)已用于婴儿免疫计划,以降低肺炎球菌疾病的发病率,但未常规用于成年人。最近的文献表明,PCV13 也可用于成人疫苗接种计划。

目的

确定 PCV13 与 PPV23 在成年人中的免疫原性和安全性。

设计

系统评价和荟萃分析。

设置

评估单次接种 PCV13 和 PPV23 后 1 个月通过调理吞噬测定(OPA)几何平均滴度(GMT)反应在成年人中的免疫原性的随机对照试验被认为符合纳入标准。

结果

共纳入 5 项随机试验,共纳入 4561 名年龄在 50-95.5 岁的受试者,其中 51%为女性。与 PPV23 组相比,PCV13 组中有 10 种血清型(1、4、5、6A、6B、9V、18C、19A、19F 和 23F)的 OPA GMT 比值(GMTR)显著更高。总体而言,PCV13 和 PPV23 之间局部和全身反应的汇总风险比(RR)无差异。PCV13 组与 PPV23 组相比,肺炎球菌初免受试者的局部反应明显更高(RR:1.15,95%CI:1.05-1.26,p=0.0025)。

结论

与 PPV23 相比,单次接种 PCV13 可在成年人中引起更好的免疫反应,同时与 PPV23 具有相似的安全性。

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