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

February 25, 2019 updated by: Vical

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2050
        • Alabama Vaccine Research Clinic at University of Alabama at Birmingham
    • California
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
    • Florida
      • Hollywood, Florida, United States, 33024
        • QPS Broward Research
      • South Miami, Florida, United States, 33143
        • QPS Miami Research Associates
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Infectious Disease Research
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates, Inc.
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina (UNC) Institute of Global Health and Infectious Diseases
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine - Division of Infectious Diseases
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VCL-HB01, 1-mL dose
VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses
Biological: VCL-HB01
Investigational Product
Placebo Comparator: Phosphate-buffered saline, 1-mL dose
PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses
Other: Phosphate-buffered saline
Placebo
Other Names:
  • PBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lesion recurrences
Time Frame: Up to Day 450
Up to Day 450

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Up to Day 450
Up to Day 450
Time to first recurrence
Time Frame: Up to Day 450
Up to Day 450
Proportion of subjects recurrence-free
Time Frame: Up to Day 450
Up to Day 450

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vical

Investigators

  • Study Director: Mammen P Mammen, MD, FIDSA, Vical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSV2-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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