Genital Herpes Clinical Trial
Official title:
A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes Infection
The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.
This study is a randomized, double-blind, placebo-controlled clinical trial of GEN-003 in
subjects who have received previous doses of GEN-003 in the GEN-003-003 clinical trial.
Eligible subjects will be randomized in a 1:1 ratio to receive 1 intramuscular (IM) dose (the
maintenance dose) of GEN-003 or placebo.
Subjects will use a daily electronic reporting tool for reporting the presence or absence of
genital herpes lesions, and severity of genital herpes symptoms.
GEN-003-005 was originally designed to follow subjects for 12 months after the maintenance
dose but a business decision, unrelated to product safety, was made by Genocea Biosciences in
3Q2017 to cease GEN-003 spending and activities.
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