Genelabs Technologies Announces Phase II Trial for
Hepatitis E Virus Vaccine
REDWOOD CITY, Calif., Sept. 25 /PRNewswire/ -- Genelabs Technologies, Inc.
(Nasdaq: GNLB - news) announced today 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
approximately 1 to 2%. However, pregnant women infected during the third trimester are at
significantly increased risk, with a mortality rate of 10% to 20% and, in many cases, fetal loss
when the mother survives. Currently there is neither specific treatment for HEV infection nor
a vaccine for its prevention. Should this current study demonstrate efficacy in preventing
disease due to HEV infection, it will mark the first time a vaccine candidate has shown utility
against this important public health problem.
I didn't even KNOW there was such a thing as E
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