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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
131
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
0.9% Normal Saline
University of Alabama-Birmingham
Birmingham, Alabama, United States
Medical Center for Clinical Research
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
The Fenway Institute
Boston, Massachusetts, United States
Change in HSV-2 viral shedding rate
Time frame: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
Immunogenicity measured by humoral (antibody) responses to vaccine antigens
Time frame: 13 weeks
Impact on clinical HSV-2 disease based on time to first recurrence
Time frame: 64 weeks
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 64 weeks
Reduction in HSV-2 viral shedding rate
Time frame: After vaccination (6 Months and 12 Months)
Impact on clinical HSV-2 disease based on lesion rate
Time frame: 64 weeks
Impact on clinical HSV-2 disease based on percent recurrence-free
Time frame: 64 weeks
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University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States
Tekton Research
Austin, Texas, United States
University of Washington
Seattle, Washington, United States