本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02234-1

摘要内容如下：

背景

戊型肝炎病毒（HEV）是一种常被忽视的急性肝炎病原体。评估戊型肝炎疫苗效力的长期持久性至关重要。

方法

本研究是在中国江苏省东台县进行的戊型肝炎疫苗随机、双盲、安慰剂对照3期临床试验的延伸。参赛人员从东台县11个乡镇招募。在最初的试验中，共招募了112604名16-65岁的健康成人，根据年龄和性别进行分层，并以1:1的比例随机分配，分别在0、1、6个月接受3剂戊型肝炎疫苗或安慰剂肌肉注射。建立了一个包括205个临床哨点的敏感的戊型肝炎监测系统，覆盖整个研究区域，并在接种疫苗后维持10年。主要转归是戊型肝炎病毒疫苗预防确诊戊型肝炎在第三剂给药后至少30天内发生的符合方案的效力。在整个研究过程中，参与者、现场研究人员和实验室工作人员对治疗分配保持不知情。该研究已在ClinicalTrials.gov（NCT01014845）注册。

调查结果

在2007年8月22日至2017年10月31日的10年研究期间，确定了90名戊型肝炎患者；疫苗组13例（0.2/10000人-年），安慰剂组77例（1.4/10000人-年），相应的疫苗有效性在改良意向治疗分析中为83.1%（95%CI 69.4~91.4），在符合方案分析中为86.6%（95%CI 73.0~94.1）。在评估免疫原性持久性的参与者亚组中，在基线时血清阴性并接种了三剂戊型肝炎疫苗的参与者中，秦东291名接种者中的254名（87.3%）在8.5岁时，安丰1740名接种者中的1270名（73.0%）在7.5岁时保持了可检测的抗体浓度。

解释

这种戊型肝炎疫苗的免疫接种可提供长达10年的抗戊型肝炎的持久保护，疫苗诱导的抗戊型肝炎抗体可持续至少8.5年。

英文原文如下：

Abstracts

BACKGROUND  Hepatitis E virus (HEV) is a frequently overlooked causative agent of acute hepatitis. Evaluating the long-term durability of hepatitis E vaccine efficacy holds crucial importance.

METHODS  This study was an extension to a randomised, double-blind, placebo-controlled, phase-3 clinical trial of the hepatitis E vaccine conducted in Dontai County, Jiangsu, China. Participants were recruited from 11 townships in Dongtai County. In the initial trial, a total of 112 604 healthy adults aged 16-65 years were enrolled, stratified according to age and sex, and randomly assigned in a 1:1 ratio to receive three doses of hepatitis E vaccine or placebo intramuscularly at month 0, month 1, and month 6. A sensitive hepatitis E surveillance system including 205 clinical sentinels, covering the entire study region, was established and maintained for 10 years after vaccination. The primary outcome was the per-protocol efficacy of hepatitis E virus vaccine to prevent confirmed hepatitis E occurring at least 30 days after administration of the third dose. Throughout the study, the participants, site investigators, and laboratory staff remained blinded to the treatment assignments. This study is registered with ClinicalTrials.gov (NCT01014845).

FINDINGS  During the 10-year study period from Aug 22, 2007, to Oct 31, 2017, 90 people with hepatitis E were identified; 13 in the vaccine group (0·2 per 10 000 person-years) and 77 in the placebo group (1·4 per 10 000 person-years), corresponding to a vaccine efficacy of 83·1% (95% CI 69·4-91·4) in the modified intention-to-treat analysis and 86·6% (73·0 to 94·1) in the per-protocol analysis. In the subsets of participants assessed for immunogenicity persistence, of those who were seronegative at baseline and received three doses of hepatitis E vaccine, 254 (87·3%) of 291 vaccinees in Qindong at the 8·5-year mark and 1270 (73·0%) of 1740 vaccinees in Anfeng at the 7·5-year mark maintained detectable concentrations of antibodies.

INTERPRETATION  Immunisation with this hepatitis E vaccine offers durable protection against hepatitis E for up to 10 years, with vaccine-induced antibodies against HEV persisting for at least 8·5 years.

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