Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine.
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.
Zhang
Jun
J
National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Xiamen University, Xiamen 361005, China.
Liu
Chong-Bo
CB
Li
Rong-Cheng
RC
Li
Yi-Min
YM
Zheng
Ying-Jie
YJ
Li
Yan-Ping
YP
Luo
Dong
D
Pan
Bai-Bin
BB
Nong
Yi
Y
Ge
Sheng-Xiang
SX
Xiong
Jun-Hui
JH
Shih
James Wai-Kuo
JW
Ng
Mun-Hon
MH
Xia
Ning-Shao
NS
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
D000914:Antibodies, Viral; D007074:Immunoglobulin G; D014614:Vaccines, Synthetic; D014765:Viral Vaccines