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一项比较 23 价肺炎球菌多糖疫苗和重复剂量 13 价肺炎球菌结合疫苗在肾移植受者中免疫原性和安全性的随机对照试验。

A randomized, controlled trial comparing the immunogenecity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in kidney transplant recipients.

机构信息

HUH Inflammation Center, Division of Infectious Diseases of Helsinki University Hospital, Helsinki University, Helsinki, Finland.

National Institute for Health and Welfare, Helsinki, Finland.

出版信息

Transpl Infect Dis. 2020 Aug;22(4):e13343. doi: 10.1111/tid.13343. Epub 2020 Jun 23.

DOI:10.1111/tid.13343
PMID:32473046
Abstract

BACKGROUND

The risk of invasive pneumococcal disease is significant among solid organ transplant (SOT) recipients. The optimal pneumococcal vaccination strategy for SOT patients is not known.

METHODS

The potential kidney transplant recipients in dialysis were randomized into two arms: to receive a 23-valent pneumococcal polysaccharide vaccine (PPV23) before transplantation or to receive a 13-valent pneumococcal conjugate vaccine (PCV13) before transplantation and a second dose of PCV13 six months after the transplantation. Serotype-specific antibody concentrations and opsonophagocytic activity (OPA) were measured before and after the first vaccination (visits V1,V2) and six and seven months after the transplantation, for example, before and after the second PCV13 (visits V3,V4).

RESULTS

Out of 133 participants, 48 (PCV13 arm) and 46 (PPV23 arm) received a kidney transplant, and 37 + 37 in both arms completed the study. After the first vaccination, the geometric mean concentrations (GMCs) in the PCV13 arm were significantly higher for 9/13 serotypes and the OPA geometric mean titers (GMTs) were significantly higher for 4/13 serotypes. At V3, the antibody levels had declined but OPA remained significantly higher for 7/13 (PCV13) vs 4/13 (PPV23) serotypes. At V4, the GMCs for 9/13 serotypes and the GMTs for 12/13 serotypes were significantly higher in the PCV13 arm. The GMCs but not GMTs were lower than at V2. There was no difference in adverse effects. No vaccine-related allograft rejection was detected.

CONCLUSIONS

The immunogenicity of PCV13 was better in dialysis patients, and revaccination with PCV13 was immunogenic and safe.

摘要

背景

实体器官移植(SOT)受者发生侵袭性肺炎球菌病的风险显著增加。目前尚不清楚 SOT 患者最佳的肺炎球菌疫苗接种策略。

方法

正在接受透析治疗的潜在肾移植受者被随机分为两组:一组在移植前接种 23 价肺炎球菌多糖疫苗(PPV23),另一组在移植前接种 13 价肺炎球菌结合疫苗(PCV13),并在移植后 6 个月接种第二剂 PCV13。在第一次接种(V1、V2 访视)前后以及移植后 6 个月和 7 个月(例如,第二次接种 PCV13 前后 V3、V4 访视)测量血清型特异性抗体浓度和调理吞噬活性(OPA)。

结果

133 名参与者中,48 名(PCV13 组)和 46 名(PPV23 组)接受了肾移植,两组各有 37 名+37 名完成了研究。第一次接种后,PCV13 组 9/13 种血清型的几何平均浓度(GMC)显著升高,4/13 种血清型的调理吞噬几何平均滴度(GMT)显著升高。在 V3 时,抗体水平下降,但 7/13(PCV13)与 4/13(PPV23)种血清型的 OPA 仍显著升高。在 V4 时,PCV13 组 9/13 种血清型的 GMC 和 12/13 种血清型的 GMT 显著升高。PCV13 组的 GMC 低于 V2,但 GMT 无差异。两组不良反应发生率无差异。未发现与疫苗相关的移植物排斥反应。

结论

PCV13 对透析患者具有更好的免疫原性,再次接种 PCV13 具有免疫原性且安全。

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