期刊
HUMAN VACCINES & IMMUNOTHERAPEUTICS
卷 11, 期 4, 页码 908-914出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/21645515.2015.1008870
关键词
efficacy; Hecolin; Hepatitis E virus; HEV 239; vaccine
资金
- National Major Scientific and Technological Special Project for Significant New Drugs Development [2013ZX09101017]
- National Natural Science Foundation of China [81373061]
- National High-tech Research & Development Program (863 Program) [2012AA02A408]
Hepatitis E virus (HEV) infection is one of the main causes of acute hepatitis worldwide. A recombinant hepatitis E vaccine, HEV 239, has been licensed in China for immunizing adults of 16 y old and above. The vaccine antigen contains pORF2 aa 368 - 606 of the HEV genotype 1 expressed in E. coli. The quality of the vaccine is controlled through a combination of biophysical, biochemical and immunochemical methods. The vaccine is well tolerated in adults. The efficacy of the HEV 239 vaccine against symptomatic and asymptomatic infection had been proven to be high during a Phase III clinical trial and long-term follow up. The safety and efficacy of HEV 239 vaccine in certain high-risk populations remains to be further investigated.
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