AsianScientist (Jan. 23, 2012) – China has approved the world’s first hepatitis E virus (HEV) vaccine this month, said China’s Ministry of Science and Technology.
HEV is transmitted via the fecal-oral route, by consuming contaminated water or food. In China, HEV is the most common type of hepatitis but no commercially available vaccine previously existed, said the World Health Organization.
The HEV 239 vaccine, sold under the trade name Hecolin™, was developed by a team of researchers from Xiamen University and Xiamen Innovax Biotech Co. Ltd. in China’s Fujian province. After 2005, the Chinese National High-tech R&D Program (863 program) began to sponsor the research.
The recombinant vaccine is prepared using virus-like particles (VLPs) of the HEV structural protein, and administered intramuscularly as three separate doses, with the second and third dose given 1 months and 6 months after the first dose.
Results of a Phase III trial involving 97,356 healthy participants aged 16 to 65 years in China’s Jiangsu province were published in The Lancet in August 2010. Half of the participants were given the vaccine, while the other half received a placebo.
In the year following the receipt of the third dose, 15 participants in the placebo group developed hepatitis E compared with none in the vaccine group, with vaccine efficacy after three doses reported as 100 percent.
Source: Xiamen Innovax Biotech Co. Ltd.
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