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DEVELOPMENT OF A LIVE ATTENUATED HSV-2 VACCINE
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Email: RSPAETE@AVIRON.COM
DESCRIPTION: (Adapted from Applicant's Abstract) Genital herpes is a major
health problem in the U.S. The prevalence of these infections is dramatically
increasing despite effective antiviral drugs. This increase puts young adults
and infants at risk of genital and neonatal herpes, respectively. Neonatal
herpes infections are associated with neurologic impairment and high mortality.
In addition, active genital herpes lesions facilitate the transmission of HIV.
Much of the transmission is due to asymptomatic shedding which highlights the
need for an efficacious prophylactic vaccine to reduce the spread of genital
herpes and thereby reduce the incidence of neonatal herpes. A recent Institute
of Medicine report on vaccine priorities for 21st century highlights the need
for a safe and effective vaccine for genital herpes. Aviron proposes to develop
a live attenuated vaccine to prevent HSV-2 disease. A live, attenuated,
recombinant HSV-2 virus lacking both copies of gamma1 34.5 gene in addition to
UL55, UL56, and US10-US12 was constructed. This recombinant was highly
neuroattenuated and genetically stable. During this proposal this virus will be
evaluated in the guinea pig model of genital herpes for safety and efficacy. In
addition further in vitro characterization will enable high quality clinical
trial material to be produced for IND enabling primate studies and early Phase
I human trials.
PROPOSED COMMERCIAL APPLICATION:
Not Available
* Information listed above is at the time of submission. *