一项采用阴性对照设计的研究中戊型肝炎疫苗对 HBsAg 阳性成人伴有医学就诊的有症状感染的有效性。
Effectiveness of a hepatitis E vaccine against medically-attended symptomatic infection in HBsAg-positive adults from a test-negative design study.
作者信息
Zhuang Chunlan, Liu Xiaohui, Huang Xingcheng, Lu Jiaoxi, Zhu Kongxin, Liao Mengjun, Chen Lu, Jiang Hanmin, Zang Xia, Wang Yijun, Yang Changlin, Liu Donglin, Zheng Zizheng, Zhang Xuefeng, Huang Shoujie, Huang Yue, Su Yingying, Wu Ting, Zhang Jun, Xia Ningshao
机构信息
State Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Innovation Platform for Industry-Education Integration in Vaccine Research, the Research Unit of Frontier Technology of Structural Vaccinology of Chinese Academy of Medical Sciences, Xiamen University, Xiamen, China.
出版信息
Nat Commun. 2025 Feb 17;16(1):1699. doi: 10.1038/s41467-025-57021-3.
The effectiveness of the hepatitis E vaccine in high-risk groups, such as chronic hepatitis B (CHB) patients, remains understudied. A key clinical manifestation of CHB is the persistent positivity of hepatitis B surface antigen (HBsAg). We conducted a test-negative design study involving 2,926 HBsAg-positive individuals (born 1941-1991; median age 49.0; male-to-female ratio of 1.4), identified through a hepatitis surveillance system, as part of the phase 3 trial (NCT01014845) of the recombinant hepatitis E vaccine HEV 239 (Hecolin). This system monitored suspected hepatitis cases and performed diagnoses across 11 townships in Dongtai, Jiangsu, China, from 2007 to 2017. Vaccine effectiveness of HEV 239 was assessed by comparing vaccination status between confirmed 96 hepatitis E cases and 2830 test-negative controls, using logistic regression adjusted for sex and age. We found that HEV 239 vaccination was associated with a reduced risk of hepatitis E among HBsAg-positive individuals, with an estimated effectiveness of 72.1% [95% confidence interval (CI) 11.2-91.2], and 81.5% (95% CI 35.9-94.6) among phase 3 trial participants. Our findings show that HEV 239 is highly effective in HBsAg-positive adults, supporting its future recommended use in this population.
戊型肝炎疫苗在慢性乙型肝炎（CHB）患者等高风险人群中的有效性仍未得到充分研究。CHB的一个关键临床表现是乙肝表面抗原（HBsAg）持续呈阳性。我们进行了一项阴性对照设计研究，纳入了2926名HBsAg阳性个体（出生于1941年至1991年；中位年龄49.0岁；男女比例为1.4），这些个体通过肝炎监测系统识别出来，作为重组戊型肝炎疫苗HEV 239（益可宁）3期试验（NCT01014845）的一部分。该系统于2007年至2017年在中国江苏省东台市的11个乡镇监测疑似肝炎病例并进行诊断。通过比较96例确诊戊型肝炎病例和2830例阴性对照的疫苗接种情况，采用经性别和年龄调整的逻辑回归分析评估HEV 239的疫苗有效性。我们发现，HEV 239疫苗接种与HBsAg阳性个体中戊型肝炎风险降低相关，估计有效性为72.1%[95%置信区间（CI）11.2 - 91.2]，在3期试验参与者中为81.5%（95%CI 35.9 - 94.6）。我们的研究结果表明，HEV 239在HBsAg阳性成年人中非常有效，支持其未来在该人群中的推荐使用。
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