title: Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine.
abstract: The candidate recombinant hepatitis E vaccine, HEV 239, protect monkeys against infection by hepatitis E virus (HEV). The safety and immunogenicity of the vaccine for humans was assessed in a randomized controlled phase II clinical trial. The study was conducted in an endemic area of southern China and consisted of a dose scheduling, involving 457 adults and a dose escalation component involving 155 high school students. The results showed that the vaccine is safe and immunogenic for humans and suggest that it could prevent new HEV infection.
authors.affiliation: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Xiamen University, Xiamen 361005, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.forename: Chong-Bo
authors.initials: CB
authors.lastname: Liu
authors.forename: Rong-Cheng
authors.initials: RC
authors.lastname: Li
authors.forename: Yi-Min
authors.initials: YM
authors.lastname: Li
authors.forename: Ying-Jie
authors.initials: YJ
authors.lastname: Zheng
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Li
authors.forename: Dong
authors.initials: D
authors.lastname: Luo
authors.forename: Bai-Bin
authors.initials: BB
authors.lastname: Pan
authors.forename: Yi
authors.initials: Y
authors.lastname: Nong
authors.forename: Sheng-Xiang
authors.initials: SX
authors.lastname: Ge
authors.forename: Jun-Hui
authors.initials: JH
authors.lastname: Xiong
authors.forename: James Wai-Kuo
authors.initials: JW
authors.lastname: Shih
authors.forename: Mun-Hon
authors.initials: MH
authors.lastname: Ng
authors.forename: Ning-Shao
authors.initials: NS
authors.lastname: Xia
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis; D002681:China / Q000453:epidemiology; D004306:Dose-Response Relationship, Immunologic; D019353:Endemic Diseases; D005260:Female; D005500:Follow-Up Studies; D016751:Hepatitis E / Q000276:immunology*; D016752:Hepatitis E virus / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000096:biosynthesis / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012015:Reference Standards; D016896:Treatment Outcome; D014614:Vaccines, Synthetic / Q000627:therapeutic use; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007074:Immunoglobulin G; D014614:Vaccines, Synthetic; D014765:Viral Vaccines