Safety and Efficacy of a Recombinant Hepatitis E Vaccine

摘要: Background Hepatitis E virus (HEV) is an important cause of viral hepatitis. We evaluated the safety and efficacy HEV recombinant protein (rHEV) vaccine in a phase 2, randomized, double-blind, placebo-controlled trial. Methods In Nepal, we studied 2000 healthy adults susceptible to infection who were randomly assigned receive three doses either rHEV or placebo at months 0, 1, 6. Active (including hospital) surveillance was used identify acute hepatitis adverse events. The primary end point development after doses. Results A total 1794 subjects (898 group 896 group) received doses; vaccinated cohort followed for median 804 days. After doses, developed 69 subjects, whom 66 group. 95.5% (95% confidence interval [CI], 85.6 98.6). intention-to-treat analysis that included all 87 sub...