Safety and immunogenicity of hepatitis E vaccine in compensated liver cirrhosis with chronic hepatitis B

作者：Xuejiao Liao, Dapeng Li, Yingying Su, Xinwu Wang, Shuting Wu, Yanling Chen, Zhiyu Li, Qiyuan Tang, Zhenghua Ma, Xiaobin Wan, Jingke Dong, Liping Zhang, Changxiang Lai, Haiyan Wang, Qing He, Jun Zhang, Fang Wang, Zheng Zhang · 发表于：Clinical Microbiology and Infection · 年份：2025 · DOI：10.1016/j.cmi.2025.02.027 · 被引用次数：4 · 研究领域：Hepatitis Viruses Studies and Epidemiology、Hepatitis B Virus Studies、Viral gastroenteritis research and epidemiology

OBJECTIVES: Hepatitis E virus (HEV) is a global health concern that causes acute hepatitis with severe consequences, particularly in patients with chronic liver disease. Despite the availability of a recombinant hepatitis E vaccine (Hecolin), its safety and immunogenicity in patients with pre-existing liver cirrhosis remain uncertain. This study aimed to assess the safety and immunogenicity of Hecolin in individuals with compensated liver cirrhosis who have chronic hepatitis B (CHB). METHODS: This study was conducted in Shenzhen City, China, from November 2019 to June 2022. The adult participants were stratified into untreated CHB, CHB treatment, CHB cirrhosis, and control groups based on their disease status. Safety assessment included adverse events and liver function tests. Serological samples were collected before vaccination and 1 month after both the first and third doses of vaccination to assess anti-HEV IgG antibodies. RESULTS: A total of 162 eligible participants, including 43 with CHB cirrhosis, 50 with treated CHB, 50 with untreated CHB, and 19 controls were included in the study. A total of 157 (96.9%) participants received three doses of the vaccine. Safety analysis revealed 7-day local adverse events in 13.95.0%, 24.0%, 12.0%, and 5.26% and systemic adverse events in 6.98%, 12.0%, 4.0%, and 0% across the cirrhosis, treated, untreated, and control groups, respectively. No serious adverse events were deemed to be causally related to vaccination. In the per-protoco...