Clinical Trial: Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic
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 Summary: 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.
Sponsor: Vical
Current Primary Outcome: Lesion recurrences [ Time Frame: Up to Day 450 ]
Original Primary Outcome: Lesion recurrences [ Time Frame: Up to Day 270 ]
Current Secondary Outcome:
- Number of participants with adverse events [ Time Frame: Up to Day 450 ]
- Time to first recurrence [ Time Frame: Up to Day 450 ]
- Proportion of subjects recurrence-free [ Time Frame: Up to Day 450 ]
Original Secondary Outcome:
- Number of participants with adverse events [ Time Frame: Up to Day 450 ]
- Proportion of subjects recurrence-free [ Time Frame: Up to Day 450 ]
- T-cell response change from base line for a subset of subjects as measured by interferon-gamma ELISPOT assay [ Time Frame: Baseline, Days 35, 63, 91, 180 and 450 ]
Information By: Vical
Dates:
Date Received: July 13, 2016
Date Started: September 2016
Date Completion: July 2018
Last Updated: April 27, 2017
Last Verified: April 2017
