Effectiveness of a hepatitis E vaccine against medically-attended symptomatic infection in HBsAg-positive adults from a test-negative design study

Chunlan Zhuang, Xiaohui Liu, Xingcheng Huang, Jiaoxi Lu, Kongxin Zhu, Mengjun Liao, Lu Chen, Hanmin Jiang, Xia Zang, Yijun Wang, Changlin Yang, Donglin Liu, Zizheng Zheng, Xuefeng Zhang, Shoujie Huang, Yue Huang (), Yingying Su (), Ting Wu, Jun Zhang () and Ningshao Xia
Additional contact information
Chunlan Zhuang: Xiamen University
Xiaohui Liu: Xiamen University
Xingcheng Huang: Xiamen University
Jiaoxi Lu: Xiamen University
Kongxin Zhu: Xiamen University
Mengjun Liao: Xiamen University
Lu Chen: Xiamen University
Hanmin Jiang: Dongtai Centre for Disease Control and Prevention
Xia Zang: Dongtai Centre for Disease Control and Prevention
Yijun Wang: Dongtai Centre for Disease Control and Prevention
Changlin Yang: Dongtai Centre for Disease Control and Prevention
Donglin Liu: Dongtai Centre for Disease Control and Prevention
Zizheng Zheng: Xiamen University
Xuefeng Zhang: Jiangsu Provincial Center for Disease Control and Prevention
Shoujie Huang: Xiamen University
Yue Huang: Xiamen University
Yingying Su: Xiamen University
Ting Wu: Xiamen University
Jun Zhang: Xiamen University
Ningshao Xia: Xiamen University

Nature Communications, 2025, vol. 16, issue 1, 1-7

Abstract: Abstract 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.

Date: 2025
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DOI: 10.1038/s41467-025-57021-3

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