Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China
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. Eli...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2448882 |
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| author | Li Zhang Qiufen Zhang Jiaye Liu Wenlong Wu Zechun Jiang Bingyu Yan Qingfan Cao Haidong Liu Huirong Pan Jingjing Lv Yi Feng Fujie Xu Shoujie Huang Aiqiang Xu |
| author_facet | Li Zhang Qiufen Zhang Jiaye Liu Wenlong Wu Zechun Jiang Bingyu Yan Qingfan Cao Haidong Liu Huirong Pan Jingjing Lv Yi Feng Fujie Xu Shoujie Huang Aiqiang Xu |
| author_sort | Li Zhang |
| collection | DOAJ |
| description | 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 (p = .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. |
| format | Article |
| id | doaj-art-2803c1a681f24e85a0262e00f51f91d7 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-2803c1a681f24e85a0262e00f51f91d72025-01-16T15:34:44ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2024.2448882Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in ChinaLi Zhang0Qiufen Zhang1Jiaye Liu2Wenlong Wu3Zechun Jiang4Bingyu Yan5Qingfan Cao6Haidong Liu7Huirong Pan8Jingjing Lv9Yi Feng10Fujie Xu11Shoujie Huang12Aiqiang Xu13Academy of Preventive Medicine, Shandong University, Jinan, ChinaDepartment of Medicine, Xiamen Innovax Biotech Co. Ltd, Xiamen, ChinaSchool of Public Health, Shenzhen University Medical School, Shenzhen, ChinaShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, ChinaDivision of Expanded Program Immunization, Rushan Center for Disease Control and Prevention, Rushan, ChinaShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, ChinaDivision of Expanded Program Immunization, Rushan Center for Disease Control and Prevention, Rushan, ChinaDivision of Expanded Program Immunization, Rushan Center for Disease Control and Prevention, Rushan, ChinaDepartment of Medicine, Xiamen Innovax Biotech Co. Ltd, Xiamen, ChinaShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, ChinaShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, ChinaGlobal Health Research Center, Duke Kunshan University, Kunshan, ChinaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, School of Public Health, Xiamen University, ChinaAcademy of Preventive Medicine, Shandong University, Jinan, ChinaAcute 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 (p = .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.https://www.tandfonline.com/doi/10.1080/21645515.2024.2448882Hepatitis E vaccinechronic hepatitis Bimmunogenicitysafety |
| spellingShingle | Li Zhang Qiufen Zhang Jiaye Liu Wenlong Wu Zechun Jiang Bingyu Yan Qingfan Cao Haidong Liu Huirong Pan Jingjing Lv Yi Feng Fujie Xu Shoujie Huang Aiqiang Xu Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China Human Vaccines & Immunotherapeutics Hepatitis E vaccine chronic hepatitis B immunogenicity safety |
| title | Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China |
| title_full | Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China |
| title_fullStr | Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China |
| title_full_unstemmed | Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China |
| title_short | Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China |
| title_sort | immunogenicity and safety of hepe hecolin r in chronic hepatitis b patients at clinically stable stage an open label study in china |
| topic | Hepatitis E vaccine chronic hepatitis B immunogenicity safety |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2448882 |
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