New England Journal of Medicine
March 5, 2015 Vol. 372 No. 10
http://www.nejm.org/toc/nejm/medical-journal

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Perspective
Making Hepatitis E a Vaccine-Preventable Disease
Eyasu Teshale, M.D., and John W. Ward, M.D.
N Engl J Med 2015; 372:899-901 March 5, 2015 DOI: 10.1056/NEJMp1415240
A hepatitis E vaccine could become a powerful new tool in the prevention and control of hepatitis E virus transmission and disease. Most immediately, it can have a role in curbing outbreaks of hepatitis E in humanitarian crises.

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Original Article
Long-Term Efficacy of a Hepatitis E Vaccine
Jun Zhang, M.Sc., Xue-Feng Zhang, M.Sc., Shou-Jie Huang, M.Sc., Ting Wu, Ph.D., Yue-Mei Hu, M.Sc., Zhong-Ze Wang, B.Sc., Hua Wang, M.D., Han-Min Jiang, B.Sc., Yi-Jun Wang, M.Sc., Qiang Yan, M.Sc., Meng Guo, B.Sc., Xiao-Hui Liu, B.Sc., Jing-Xin Li, M.Sc., Chang-Lin Yang, B.Sc., Quan Tang, B.Sc., Ren-Jie Jiang, M.Sc., Hui-Rong Pan, Ph.D., Yi-Min Li, M.D., J. Wai-Kuo Shih, Ph.D., Mun-Hon Ng, Ph.D., Feng-Cai Zhu, M.Sc., and Ning-Shao Xia
N Engl J Med 2015; 372:914-922 March 5, 2015 DOI: 10.1056/NEJMoa1406011
Abstract
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. (Funded by the Chinese Ministry of Science and Technology and others; ClinicalTrials.gov number, NCT01014845.)