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一项比较两种剂量和三种剂量甲型肝炎疫苗在肾移植受者中疗效的随机对照试验。

A randomized controlled trial of comparative effectiveness between the 2 dose and 3 dose regimens of hepatitis a vaccine in kidney transplant recipients.

机构信息

Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

出版信息

Sci Rep. 2021 Jan 8;11(1):50. doi: 10.1038/s41598-020-80052-3.

DOI:10.1038/s41598-020-80052-3
PMID:33420114
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7794436/
Abstract

Hepatitis A virus (HAV) is able to cause a spectrum of illnesses ranging from no symptom to fulminant hepatitis which may lead to acute kidney injury. Although hepatitis A vaccine is recommended in non-immune solid organ transplant recipients who live in or travel to endemic areas, the standard 2-dose vaccination regimen demonstrated less favorable immunogenicity among these population. The 3-dose regimen showed higher response rate and immune durability in patients with human immunodeficiency virus. However, this strategy has never been studied in solid organ transplant recipients. A single-center, open-labeled, computer-based randomized controlled trial (RCT) with a 2:1 allocation ratio was conducted from August 2017 to December 2018. The study compared the seroconversion rate after receiving 2- or 3-dose regimen of hepatitis A vaccine at 0, 6 and 0, 1, 6 months, respectively, in non-immune kidney transplant recipients. A total of 401 adult kidney transplant recipients were screened for anti-HAV IgG and 285 subjects had positive results so the seroprevalence was 71.1%. Of 116 seronegative recipients, 93 (80.2%) completed vaccination; 60 and 33 participants completed 2- and 3-dose vaccination, respectively. The baseline characteristics were comparable between both groups. The seroconversion rate at 1 month after vaccination was 51.7% in the standard 2-dose regimen and 48.5% in the 3-dose regimen (p = 0.769). Overall, the seroconversion rate appeared to be associated with high estimated glomerular infiltration rate, high serum albumin, and low intensity immunosuppressive regimen. Seroconversion rate after hepatitis A vaccination in kidney transplant recipients was less favorable than healthy population. Three-dose regimen did not show superior benefit over the standard 2-dose regimen. Other strategies of immunization may increase immunogenicity among kidney transplant recipients.

摘要

甲型肝炎病毒(HAV)可引起一系列疾病,从无症状到暴发性肝炎,甚至可能导致急性肾损伤。虽然在生活或前往流行地区的非免疫性实体器官移植受者中推荐使用甲型肝炎疫苗,但该疫苗在该人群中的免疫原性较差。三剂方案在人类免疫缺陷病毒患者中显示出更高的应答率和免疫持久性。然而,该策略从未在实体器官移植受者中进行过研究。一项单中心、开放性、基于计算机的随机对照试验(RCT),采用 2:1 分配比例,于 2017 年 8 月至 2018 年 12 月进行。该研究比较了分别在 0、6 个月和 0、1、6 个月时接受两剂和三剂甲型肝炎疫苗后,非免疫性肾移植受者的血清转化率。共筛选了 401 例成年肾移植受者的抗-HAV IgG,285 例有阳性结果,因此血清流行率为 71.1%。在 116 例血清阴性受者中,93 例(80.2%)完成了疫苗接种;60 例和 33 例参与者分别完成了两剂和三剂接种。两组的基线特征相似。标准两剂方案接种后 1 个月的血清转化率为 51.7%,三剂方案为 48.5%(p=0.769)。总体而言,血清转化率似乎与高估计肾小球滤过率、高血清白蛋白和低强度免疫抑制方案有关。肾移植受者接种甲型肝炎疫苗后的血清转化率不如健康人群理想。三剂方案并不比标准两剂方案更有优势。免疫接种的其他策略可能会提高肾移植受者的免疫原性。

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