肾移植患者的疱疹病毒感染（HINT）-一项前瞻性观察队列研究。

Herpes Virus Infections in Kidney Transplant Patients (HINT) - a prospective observational cohort study.

机构信息

Viro-Immunology Research Unit, Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

Department of Health Technology, Technical University of Denmark, Kongens Lyngby, Denmark.

出版信息

BMC Infect Dis. 2023 Oct 16;23(1):687. doi: 10.1186/s12879-023-08663-5.

DOI:10.1186/s12879-023-08663-5

PMID:37845608

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10578002/

Abstract

BACKGROUND

Kidney transplant recipients receive maintenance immunosuppressive therapy to avoid allograft rejection resulting in increased risk of infections and infection-related morbidity and mortality. Approximately 98% of adults are infected with varicella zoster virus, which upon reactivation causes herpes zoster. The incidence of herpes zoster is higher in kidney transplant recipients than in immunocompetent individuals, and kidney transplant recipients are at increased risk of severe herpes zoster-associated disease. Vaccination with adjuvanted recombinant glycoprotein E subunit herpes zoster vaccine (RZV) prevents herpes zoster in older adults with excellent efficacy (90%), and vaccination of kidney transplant candidates is recommended in Danish and international guidelines. However, the robustness and duration of immune responses after RZV vaccination, as well as the optimal timing of vaccination in relation to transplantation remain unanswered questions. Thus, the aim of this study is to characterize the immune response to RZV vaccination in kidney transplant candidates and recipients at different timepoints before and after transplantation.

METHODS

The Herpes Virus Infections in Kidney Transplant Patients (HINT) study is a prospective observational cohort study. The study will include kidney transplant candidates on the waiting list for transplantation (n = 375) and kidney transplant recipients transplanted since January 1, 2019 (n = 500) from all Danish kidney transplant centers who are offered a RZV vaccine as routine care. Participants are followed with repeated blood sampling until 12 months after inclusion. In the case of transplantation or herpes zoster disease, additional blood samples will be collected until 12 months after transplantation. The immune response will be characterized by immunophenotyping and functional characterization of varicella zoster virus-specific T cells, by detection of anti-glycoprotein E antibodies, and by measuring cytokine profiles.

DISCUSSION

The study will provide new knowledge on the immune response to RZV vaccination in kidney transplant candidates and recipients and the robustness and duration of the response, potentially enhancing preventive strategies against herpes zoster in a population at increased risk.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT05604911).

摘要

背景

肾移植受者接受维持性免疫抑制治疗，以避免同种异体移植物排斥反应，从而增加感染风险和与感染相关的发病率和死亡率。大约 98%的成年人感染了水痘带状疱疹病毒，该病毒在重新激活后会引起带状疱疹。肾移植受者带状疱疹的发病率高于免疫功能正常的个体，且肾移植受者发生严重带状疱疹相关疾病的风险增加。用佐剂重组糖蛋白 E 亚单位带状疱疹疫苗（RZV）进行疫苗接种可在老年人中预防带状疱疹，具有极好的疗效（90%），丹麦和国际指南均推荐对肾移植候选者进行疫苗接种。然而，RZV 接种后的免疫反应的稳健性和持续时间，以及与移植相关的最佳接种时间仍然是未解决的问题。因此，本研究的目的是在移植前和移植后不同时间点，描述肾移植候选者和受者对 RZV 接种的免疫反应。

方法

肾移植患者疱疹病毒感染（HINT）研究是一项前瞻性观察队列研究。该研究将包括在移植等待名单上的肾移植候选者（n=375）和自 2019 年 1 月 1 日以来接受移植的肾移植受者（n=500），这些患者均来自丹麦所有的肾移植中心，他们作为常规护理被提供 RZV 疫苗。参与者在纳入后 12 个月内进行重复采血。在发生移植或带状疱疹疾病的情况下，将在移植后 12 个月内收集更多的血样。通过免疫表型和水痘带状疱疹病毒特异性 T 细胞的功能特征、抗糖蛋白 E 抗体的检测以及细胞因子谱的测量，来描述免疫反应。