Zhang Li, Zhang Qiufen, Liu Jiaye, Wu Wenlong, Jiang Zechun, Yan Bingyu, Cao Qingfan, Liu Haidong, Pan Huirong, Lv Jingjing, Feng Yi, Xu Fujie, Huang Shoujie, Xu Aiqiang
Academy of Preventive Medicine, Shandong University, Jinan, China.
Division of Expanded Program Immunization, Rushan Center for Disease Control and Prevention, Rushan, China.
Hum Vaccin Immunother. 2025 Dec;21(1):2448882. doi: 10.1080/21645515.2024.2448882. Epub 2025 Jan 10.
Acute hepatitis E infection could induce severe outcomes among chronic hepatitis B (CHB) patients. Between 2016 and 2017, an open-label study was conducted to evaluate the immunogenicity and safety of hepatitis E vaccine (HepE) in CHB patients, using healthy adults as parallel controls in China. Eligible participants who were aged ≥30 y were enrolled in the study. The CHB group included participants who had ever developed symptoms of hepatitis because of CHB but was currently at a clinically stable stage, which was defined as ALT ≤ 1.5 times of upper limit of the normal range (ULN) in this study. The control group included healthy adults who had hepatitis B surface antigen (HBsAg) negative. HepE was administered for 0, 1, 6 months for all participants. At 1 month after the third-dose vaccination (month 7), the seroconversion rates of anti-HEV IgG were >97% in both groups. The geometric mean concentration (GMC) of anti-HEV IgG in the CHB group was non-inferior to the healthy adult group (0.69 WU/mL, 95% CI 0.55-0.85). The proportion of the participants with adverse events ≥ grade 3 was similar in both groups ( = .99), and no vaccine-associated severe adverse events were identified. Changes in the liver function indicators were not of clinical significance. The HepE was highly immunogenic and well tolerated among clinically stable CHB patients and healthy adults.
急性戊型肝炎感染可在慢性乙型肝炎（CHB）患者中导致严重后果。2016年至2017年，在中国开展了一项开放标签研究，以评估戊型肝炎疫苗（HepE）在CHB患者中的免疫原性和安全性，将健康成年人作为平行对照。年龄≥30岁的符合条件参与者被纳入研究。CHB组包括曾因CHB出现肝炎症状但目前处于临床稳定阶段的参与者，在本研究中临床稳定阶段定义为谷丙转氨酶（ALT）≤正常范围上限（ULN）的1.5倍。对照组包括乙型肝炎表面抗原（HBsAg）阴性的健康成年人。所有参与者均在0、1、6个月接种HepE。在第三剂疫苗接种后1个月（第7个月），两组抗-HEV IgG的血清转化率均>97%。CHB组抗-HEV IgG的几何平均浓度（GMC）不劣于健康成年组（0.69 WU/mL，95%CI 0.55 - 0.85）。两组中不良事件≥3级的参与者比例相似（P = 0.99），未发现与疫苗相关的严重不良事件。肝功能指标变化无临床意义。HepE在临床稳定的CHB患者和健康成年人中具有高度免疫原性且耐受性良好。
