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十三价肺炎球菌结合疫苗在 23 价肺炎球菌多糖疫苗免疫初治和预免疫的慢性血液透析治疗患者中的免疫原性和安全性:一项纵向准实验性 IV 期研究。

Immunogenicity and safety of the 13-valent Pneumococcal Conjugate vaccine in 23-valent pneumococcal polysaccharide vaccine-naive and pre-immunized patients under treatment with chronic haemodialysis: a longitudinal quasi-experimental phase IV study.

机构信息

Division of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium.

Department of Public Healths, Ghent University, Belgium.

出版信息

Clin Microbiol Infect. 2018 Jan;24(1):65-71. doi: 10.1016/j.cmi.2017.05.016. Epub 2017 May 27.

DOI:10.1016/j.cmi.2017.05.016
PMID:28559003
Abstract

OBJECTIVE

To benchmark the immunogenicity of pneumococcal conjugated vaccine (PCV-13) versus pneumococcal polysaccharide vaccine (PPV-23) in haemodialysis patients pre-vaccinated or not with PPV-23.

METHODS

The study is a longitudinal quasi-experimental phase IV study in chronic haemodialysis patients aged ≥50 years. Total (ELISA) and functional (opsonophagocytic assay) antibodies after pneumococcal vaccination were quantified at baseline, and after 28 and 365 days. Of 201 eligible patients, 155 were included. Patients were divided in four groups. PPV-23 naive patients were randomized to PPV-23 (40) or PCV-13 (40) vaccination. PPV-23-pre-vaccinated patients were categorized as being vaccinated more (40) or less (35) than 4 years before the study and all received PCV-13.

RESULTS

Patients among the four groups had a significant ELISA antibody response for most serotypes that remained significant up to day 365 versus baseline. In PPV-23-naive patients, ELISA antibody titres were significantly higher among PCV-13 versus PPV-23 recipients for six serotypes (1.85-2.34-fold) after 28 days, and remained significantly higher for one serotype (6A, 1.57-fold) after 365 days. Following PCV-13 vaccination, increase in ELISA antibody titres was significantly higher among PPV-23-naive versus PPV-23-pre-vaccinated patients for 12 serotypes after 28 days (1.68-7.74-fold) and remained significantly higher in ten serotypes (1.44-3.29-fold) after 365 days.

CONCLUSION

Immune response after PPV-23 and PCV-13 remains significant for at least 1 year in non-PPV-23-pre-vaccinated patients. Among vaccine-naive haemodialysis patients PCV-13 seems more immunogenic than PPV-23. Immune response to PCV-13 is weaker in PPV-23-pre-vaccinated compared with vaccine-naive patients.

摘要

目的

比较在接种过或未接种过肺炎球菌多糖疫苗(PPV-23)的血液透析患者中,肺炎球菌结合疫苗(PCV-13)与肺炎球菌多糖疫苗(PPV-23)的免疫原性。

方法

这是一项针对≥50 岁慢性血液透析患者的纵向准实验性 IV 期研究。在基线时、接种后 28 天和 365 天,检测肺炎球菌疫苗接种后的总(ELISA)和功能(调理吞噬测定)抗体。在 201 名符合条件的患者中,有 155 名被纳入研究。患者分为四组。PPV-23 初免患者被随机分为接受 PPV-23(40 名)或 PCV-13(40 名)接种。PPV-23 预接种患者分为研究前 4 年以上(40 名)和 4 年以内(35 名)接种,所有患者均接受 PCV-13 接种。

结果

四组患者对大多数血清型均有显著的 ELISA 抗体应答,且这种应答在接种后 365 天仍显著高于基线。在 PPV-23 初免患者中,与接受 PPV-23 接种者相比,接种 PCV-13 后 28 天 6 个血清型(1.85-2.34 倍)的 ELISA 抗体滴度显著升高,365 天时仍有 1 个血清型(6A,1.57 倍)的抗体滴度显著升高。接种 PCV-13 后,与 PPV-23 预接种患者相比,28 天时 12 个血清型(1.68-7.74 倍)的 ELISA 抗体滴度升高更显著,365 天时仍有 10 个血清型(1.44-3.29 倍)的抗体滴度升高更显著。

结论

未接种过 PPV-23 的患者,接种 PPV-23 和 PCV-13 后的免疫应答至少可持续 1 年。在疫苗初免的血液透析患者中,PCV-13 似乎比 PPV-23 更具免疫原性。与疫苗初免患者相比,接种过 PPV-23 的患者对 PCV-13 的免疫应答较弱。

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