NCT02030301

Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Vical · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Genital Herpes Simplex Type 2

Interventions

Type	Name	Description
BIOLOGICAL	VCL-HB01	Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
BIOLOGICAL	VCL-HM01	Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
BIOLOGICAL	PBS	Phosphate-buffered saline

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-06-01
• Completion: 2016-02-01
• First posted: 2014-01-08
• Last updated: 2019-02-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study