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NCT02837575 Clinical Trial

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

Herpes Genitalis Clinical Trial

— HSV-2  

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 Genital HSV-2 Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02837575
Other study ID # HSV2-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2016
Est. completion date December 2018

Study information
Verified date February 2019
Source Vical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 261
Est. completion date December 2018
Est. primary completion date April 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• VCL-HB01
Investigational Product
Other:
• Phosphate-buffered saline
Placebo

Locations
Country Name City State
United States Alabama Vaccine Research Clinic at University of Alabama at Birmingham Birmingham Alabama
United States University of North Carolina (UNC) Institute of Global Health and Infectious Diseases Chapel Hill North Carolina
United States University of Illinois Chicago Illinois
United States QPS Broward Research Hollywood Florida
United States Indiana University Infectious Disease Research Indianapolis Indiana
United States The Center for Pharmaceutical Research Kansas City Missouri
United States Central Kentucky Research Associates, Inc. Lexington Kentucky
United States Clinical Research Associates, Inc. Nashville Tennessee
United States Rochester Clinical Research, Inc. Rochester New York
United States University of Utah School of Medicine - Division of Infectious Diseases Salt Lake City Utah
United States Medical Center for Clinical Research San Diego California
United States University of Washington Seattle Washington
United States QPS Miami Research Associates South Miami Florida
United States Comprehensive Clinical Trials, LLC West Palm Beach Florida
United States Heartland Research Associates, LLC Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Vical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lesion recurrences Up to Day 450
Secondary Number of participants with adverse events Up to Day 450
Secondary Time to first recurrence Up to Day 450
Secondary Proportion of subjects recurrence-free Up to Day 450
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Active, not recruiting NCT04950712 - An Epidemiological Study to Assess Performance of Using Healthcare Tools to Understand Genital Herpes Simplex Virus-2 (HSV-2) in Patients ≥ 18 Years of Age in the United States and Europe.
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Completed NCT00158509 - Randomised Controlled Trial Assessing the Impact of Genital Herpes Suppressive Therapy on HIV Shedding Phase 2
Completed NCT00076232 - A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes Phase 3
Completed NCT00023582 - HIV and Genital Herpes Among High-Risk Men Who Have Sex With Men (MSM) in Lima, Peru N/A