Genital Herpes Simplex Type 2 Clinical Trial
Official title:
A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
This study is a randomized, double-blind, placebo-controlled clinical trial of a new
formulation of GEN-003 for treatment of HSV-2 genital infection.
Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive
days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then
complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each
subject will be followed for one year after the third dose.
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