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

Vical261 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

261

Conditions

Herpes Genitalis

Interventions

VCL-HB01BIOLOGICAL

Investigational Product

Phosphate-buffered salineOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Lesion recurrences

Time frame: Up to Day 450

Secondary Outcomes

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

Data from ClinicalTrials.gov

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