Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
- Conditions
- Herpes Genitalis
- Registration Number
- NCT02837575
- Lead Sponsor
- Vical
- Brief Summary
The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
- Detailed Description
To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- HSV-2 seropositive
- A minimum of 1 year of reported history of genital herpes with recurrences.
- History of receiving an investigational HSV vaccine
- Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
- Pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Lesion recurrences Up to Day 450
- Secondary Outcome Measures
Name Time Method Proportion of subjects recurrence-free Up to Day 450 Number of participants with adverse events Up to Day 450 Time to first recurrence Up to Day 450
Related Research Topics
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Trial Locations
- Locations (15)
Alabama Vaccine Research Clinic at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
QPS Broward Research
🇺🇸Hollywood, Florida, United States
QPS Miami Research Associates
🇺🇸South Miami, Florida, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
Indiana University Infectious Disease Research
🇺🇸Indianapolis, Indiana, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Scroll for more (5 remaining)Alabama Vaccine Research Clinic at University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States