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Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine.
Zhang, Jun; Liu, Chong-Bo; Li, Rong-Cheng; Li, Yi-Min; Zheng, Ying-Jie; Li, Yan-Ping; Luo, Dong; Pan, Bai-Bin; Nong, Yi; Ge, Sheng-Xiang; Xiong, Jun-Hui; Shih, James Wai-Kuo; Ng, Mun-Hon; Xia, Ning-Shao.
Affiliation
  • Zhang J; National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Xiamen University, Xiamen 361005, China.
Vaccine ; 27(12): 1869-74, 2009 Mar 13.
Article in En | MEDLINE | ID: mdl-19168109
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.
Subject(s)

Full text: 1 Collection: 01-internacional Health context: 2_ODS3 / 3_ND Database: MEDLINE Main subject: Viral Vaccines / Hepatitis E virus / Hepatitis E Type of study: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Adolescent / Adult / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: En Journal: Vaccine Year: 2009 Document type: Article

Full text: 1 Collection: 01-internacional Health context: 2_ODS3 / 3_ND Database: MEDLINE Main subject: Viral Vaccines / Hepatitis E virus / Hepatitis E Type of study: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Adolescent / Adult / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: En Journal: Vaccine Year: 2009 Document type: Article