Hepatitis E vaccine development: a 14 year odyssey.
The first prophylactic vaccine, Hecolin®, against hepatitis E virus (HEV) infection and the HEV associated disease was approved by China's State Food and Drug Administration (SFDA) in December 2011. Key milestones during the 14-year HEV vaccine development are summarized in this commentary.  After years of innovative research the recombinant virus-like particle (VLP) based antigen with virion-like epitopes was successfully produced in E. coli production platform on a commercial scale. Safety and efficacy of this vaccine was demonstrated in a large scale phase III clinical trial.
National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Xiamen University, Xiamen, China.
Ting
T
Wu
Shao-Wei
SW
Li
Jun
J
Zhang
Mun-Hon
MH
Ng
Ning-Shao
NS
Xia
Qinjian
Q
Zhao
D017326:Clinical Trials, Phase III as Topic; D016751:Hepatitis E / Q000276:immunology / Q000517:prevention & control; D016752:Hepatitis E virus / Q000276:immunology*; D006801:Humans; D014761:Viral Hepatitis Vaccines / Q000276:immunology* / Q000627:therapeutic use*
D014761:Viral Hepatitis Vaccines