Trials / Completed
CompletedNCT02837575
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
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 Genital HSV-2 Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- Vical · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VCL-HB01 | Investigational Product |
| OTHER | Phosphate-buffered saline | Placebo |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-04-01
- Completion
- 2018-12-01
- First posted
- 2016-07-19
- Last updated
- 2019-02-27
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02837575. Inclusion in this directory is not an endorsement.