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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Placebo
University of Alabama Birmingham
Birmingham, Alabama, United States
Medical Center for Clinical Research
San Diego, California, United States
Optimus Medical Group
San Francisco, California, United States
UNC Health
Chapel Hill, North Carolina, United States
Percentage of Days With Genital Herpes Lesions
Subject-reported via electronic diary
Time frame: The 6-month period after vaccination
Number of Genital Herpes Recurrences
Subject-reported via electronic diary
Time frame: The 6-month period after vaccination
Number of Subjects Without Genital Herpes Recurrence
Subject-reported via electronic diary
Time frame: 6 months after vaccination
Days Until First Genital Herpes Recurrence
Subject-reported via electronic diary
Time frame: The 6-month period after vaccination
Duration of Genital Herpes Recurrences
Time in days per genital herpes recurrence
Time frame: The 6-month period after vaccination
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
NW Dermatology and Research Clinic
Portland, Oregon, United States
Tekton Research
Austin, Texas, United States
University of Washington
Seattle, Washington, United States