Vaccine hope for hepatitis E7th September 2010
A new vaccine developed in China against the hepatitis E virus has been shown to be safe and effective, recent trials show.
Researchers said the new vaccine safely protects most adults from the disease, which is associated with poor sanitation.
In a phase III trial on healthy adults of both sexes, the HEV 239 vaccine was shown to be 100% effective.
Publishing their results online in The Lancet, researchers led by Xia Ningshao, director of the Institute of Diagnostics and Vaccine Development in Infectious Diseases at Xiamen University in the southeastern province of Fujian, said this was the first vaccine against the disease to reach this stage.
Trial participants were randomly dosed with three doses of the vaccine or a placebo. The first two doses were administered in the first month of the trial, and a third was given six months later.
At the end of a 13-month period, none of the vaccinated participants had contracted the disease, compared with 15 cases of hepatitis E in the control group.
The authors said there were few adverse effects reported with the vaccine, and those that were appeared to be mild in nature.
China's drug regulatory body is now taking a closer look at the vaccine.
The approval process by the State Food and Drug Administration in Beijing could take up several months to complete, however.
Xia said that hepatitis E currently made up more than 50% of total acute hepatitis cases, suggesting a huge potential demand for the new vaccine.
United States viral hepatitis expert Scott Holmberg said the vaccine could be important for tackling hepatitis E outbreaks while at the same time helping developing countries to improve sanitation.
Holmberg, an expert at the US Centers for Disease Control and Prevention, said further trials in pregnant women and infants were still needed, and that these groups were more likely to die from the virus than the trial participants.
Hepatitis E is particularly deadly in pregnancy, killing up to a quarter of expectant mothers who contract the disease. Even if pregnant women survive it, the infection can lead to spontaneous abortion and stillbirth.
Holmberg added that it was still unclear how long the vaccine would remain effective.
The authors also called for further research to assess the HEV 239 vaccine in patients with other chronic liver diseases.
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Title: Vaccine hope for hepatitis E
Author: Luisetta Mudie
Article Id: 15973
Date Added: 7th Sep 2010