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Jun Zhang:Long-Term Efficacy of a Hepatitis E Vaccine

Date:2016/10/18 Views:

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, rather than (95% confidence interval, 71 to 84) [corrected]. 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.).

Link1:Long-Term Efficacy of a Hepatitis E Vaccine

http://www.nejm.org/doi/full/10.1056/NEJMoa1406011

Link2:Making Hepatitis E a Vaccine-Preventable Disease

http://www.nejm.org/doi/full/10.1056/NEJMp1415240