The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3 doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
Alabama Vaccine Research Clinic
Birmingham, Alabama, United States
Broward Research Group
Hollywood, Florida, United States
Indiana University Infectious Diseases Research
Indianapolis, Indiana, United States
Westover Heights Clinic
Portland, Oregon, United States
Number of participants with adverse events
Time frame: Up to Day 420
Viral shedding rate change from baseline
Time frame: Baseline, Day 150
Genital lesion rate change from baseline
Time frame: Baseline, Day 150
HSV DNA copy numbers change from baseline
Time frame: Baseline, Day 150
Genital recurrence rate compared with placebo
Time frame: Up to Day 330
Subclinical genital shedding rate change from baseline
Time frame: Up to Day 150
T-cell and/or antibody responses change from baseline
Time frame: Baseline, Days 7, 35, 63, 150, 330
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Center for Clinical Studies
Houston, Texas, United States
University of Utah - Division of Infectious Diseases
Salt Lake City, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States