背景:戊型肝炎病毒(HEV)是一种经常被忽视的急性肝炎病原体。评估戊型肝炎疫苗疗效的长期持久性至关重要。
方法:这项研究是对随机,双盲,安慰剂对照,在东台县进行的戊型肝炎疫苗的3期临床试验,江苏,中国。参与者来自东台县11个乡镇。在最初的审判中,共有112604名16-65岁的健康成年人参加了研究,根据年龄和性别分层,并以1:1的比例随机分配,在第0个月,第1个月和第6个月,肌内注射三剂戊型肝炎疫苗或安慰剂。一个敏感的戊型肝炎监测系统,包括205个临床哨兵,覆盖整个研究区域,在接种疫苗后建立并维持10年。主要结果是戊型肝炎病毒疫苗在第三剂给药后至少30天预防确认的戊型肝炎发生的符合方案功效。在整个研究过程中,参与者,现场调查员,实验室工作人员仍然对治疗任务视而不见。本研究在ClinicalTrials.gov(NCT01014845)注册。
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例戊型肝炎患者;疫苗组13例(每10000人年0·2例),安慰剂组77例(每10000人年1·4例)。在改良的意向治疗分析中,疫苗效力为83·1%(95%CI69·4~91·4),在符合方案分析中,疫苗效力为86·6%(73·0~94·1).在评估免疫原性持久性的参与者亚群中,那些在基线时血清阴性并接受三剂戊型肝炎疫苗的人,在8·5年的标记中,秦东291名疫苗中有254名(87·3%),在7·5年的标记中,安丰1740名疫苗中有1270名(73·0%)保持了可检测的抗体浓度。
结论:使用这种戊型肝炎疫苗进行免疫接种可在长达10年的时间内对戊型肝炎提供持久的保护。疫苗诱导的抗HEV抗体持续至少8·5年。
背景:国家自然科学基金,福建省自然科学基金,中国医学科学院医学创新基金,中央大学基础研究基金。
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).
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: National Natural Science Foundation of China, Fujian Provincial Natural Science Foundation, Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, and the Fundamental Research Funds for the Central Universities.