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Vaccine To Undergo Phase II Clinical Trial In Nepal.(hepatitis E vaccine)
2001 OCT 17 - (NewsRx.com & NewsRx.net) -- Genelabs Technologies, Inc. announced September 25, 2001, the initiation of a Phase II clinical trial of an investigational new vaccine for prevention of disease caused by hepatitis E virus (HEV).
The trial is being conducted by the Walter Reed Army Institute of Research in collaboration with the Medical Department of the Royal Nepal Army, the U.S. National Institutes of Health, and Genelabs' licensee GlaxoSmithKline Biologicals. The trial has enrolled approximately 2,000 adult volunteers who are to receive three doses of either HEV vaccine or placebo over six months.
The study is being conducted in Nepal, where HEV causes annual epidemic outbreaks and has an historical attack rate that is among the highest in the world. The anticipated duration of follow-up will be 18 months after the last dose.
HEV is the leading cause of enterically transmitted hepatitis among adults in the developing world. Infection with HEV can cause severe and prolonged illness, including fever, jaundice, and nausea. Mortality associated with HEV infection in the general population is 1-2%. However, pregnant women ...
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Source: HighBeam Research, Vaccine To Undergo Phase II Clinical Trial In Nepal.(hepatitis E...