戊型肝炎疫苗的长期效果

Long-term efficacy of a hepatitis E vaccine
2015-09-15 12:03发表评论
作者:Zhang J., Zhang X.-F., Huang S.-J., Wu T., Hu Y.-M., Wang Z.-Z., Wang H., Jiang H.-M., Wang Y.-J., Yan Q., Guo M., Liu X.-H., Li J.-X., Yang C.-L., Tang Q., Jiang R.-J., Pan H.-R., Li Y.-M., Shih J.W.-K., Ng M.-H., Zhu F.-C., Xia N.-S.
机构: 厦门大学国家传染病诊断试剂与疫苗工程技术研究中心 分子疫苗学和分子诊断学国家重点实验室
期刊: NEW ENGL J MED 2015年3月10期372卷

BACKGROUND Hepatitis E virus (HEV) is a leading cause of acute hepatitis. The long-term efficacy of a hepatitis E vaccine needs to be determined. METHODS In an initial efficacy study, we randomly assigned healthy adults 16 to 65 years of age to receive three doses of either a hepatitis E vaccine (vaccine group; 56,302 participants) or a hepatitis B vaccine (control group; 56,302 participants). The vaccines were administered at 0, 1, and 6 months, and the participants were followed for 19 months. In this extended follow-up study, the treatment assignments of all participants remained double-blinded, and follow-up assessments of efficacy, immunogenicity, and safety were continued for up to 4.5 years. RESULTS During the 4.5-year study period, 60 cases of hepatitis E were identified; 7 cases were confirmed in the vaccine group (0.3 cases per 10,000 person-years), and 53 cases in the control group (2.1 cases per 10,000 person-years), representing a vaccine efficacy of 86.8% (95% confidence interval, 71 to 94) in the modified intention- to-treat analysis. Of the participants who were assessed for immunogenicity and were seronegative at baseline, 87% of those who received three doses of the hepatitis E vaccine maintained antibodies against HEV for at least 4.5 years; HEV antibody titers developed in 9% in the control group. The rate of adverse events was similar in the two groups. CONCLUSIONS Immunization with this hepatitis E vaccine induced antibodies against HEV and provided protection against hepatitis E for up to 4.5 years. Copyright © 2015 Massachusetts Medical Society.

 

通讯机构:State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics Vaccine Development in Infectious Diseases, Xiamen University, Xiang'an South Rd., Xiamen, China
学科代码:内科学   关键词:戊型肝炎 疫苗 ,中国作者重要发表 爱思唯尔医学网, Elseviermed
来源: Scopus
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