Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine

Status:	Completed
Conditions:	Infectious Disease, Genital Herpes
Therapuetic Areas:	Immunology / Infectious Diseases, Other
Healthy:	No
Age Range:	18 - 50
Updated:	3/1/2019
Start Date:	September 2016
End Date:	December 2018

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

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).

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.

Inclusion Criteria:

- HSV-2 seropositive

- A minimum of 1 year of reported history of genital herpes with recurrences.

Exclusion Criteria:

- 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

We found this trial at

sites

Clinical Research Associates

Nashville, Tennessee 37203

from

Nashville, TN