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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Vical
Sponsor:
Information provided by (Responsible Party):
Vical
ClinicalTrials.gov Identifier:
NCT02837575
First received: July 13, 2016
Last updated: February 17, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Herpes Genitalis
Biological: VCL-HB01
Other: Phosphate-buffered saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vical:

Primary Outcome Measures:
  • Lesion recurrences [ Time Frame: Up to Day 450 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 225
Study Start Date: September 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PBS

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02837575

Locations
United States, Alabama
Alabama Vaccine Research Clinic at University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-2050
Contact: Santorra King    205-996-4099    santorraking@uabmc.edu   
United States, California
Medical Center for Clinical Research Recruiting
San Diego, California, United States, 92108
Contact: Kim Kerr    619-521-2841    kkerr@mccresearch.com   
United States, Florida
QPS Broward Research Recruiting
Hollywood, Florida, United States, 33024
Contact: Barbara Garcia    954-374-1150 ext 114    barbara.garcia@qps.com   
QPS Miami Research Associates Recruiting
South Miami, Florida, United States, 33143
Contact: Meredith Arguelles, LPN, CCRC    305-598-3125    Meredith.Anguelles@qps.com   
Comprehensive Clinical Trials, LLC Recruiting
West Palm Beach, Florida, United States, 33409
Contact: Jamie Ackerman, CCRC, CCRP    561-478-3177    jackerman@cctllc.net   
United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Regina Harden    312-413-5897    ginaha@uic.edu   
United States, Indiana
Indiana University Infectious Disease Research Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Paula Johnson    317-278-2945    johnpaul@iu.edu   
United States, Kansas
Heartland Research Associates, LLC Recruiting
Wichita, Kansas, United States, 67207
Contact: Melissa Burton    316-689-6626    mburton@heartlandresearch.com   
United States, Kentucky
Central Kentucky Research Associates, Inc. Recruiting
Lexington, Kentucky, United States, 40509
Contact: Tracy Hudson    859-977-7142    thudson@ckrainc.com   
United States, Missouri
The Center for Pharmaceutical Research Recruiting
Kansas City, Missouri, United States, 64114
Contact: Enrollment Services    816-943-0770    es@cprkc.com   
United States, New York
Rochester Clinical Research, Inc. Recruiting
Rochester, New York, United States, 14609
Contact: Deb Lovett    585-288-0890    volunteer@rcrclinical.com   
United States, North Carolina
University of North Carolina (UNC) Institute of Global Health and Infectious Diseases Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Erin Hoffman    919-843-0720    erin_hoffman@med.unc.edu   
United States, Tennessee
Clinical Research Associates, Inc. Recruiting
Nashville, Tennessee, United States, 37203
Contact: Gwen Mooney    615-329-0197    gwen@cranashville.com   
United States, Utah
University of Utah School of Medicine - Division of Infectious Diseases Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Mary Jane Tinnes    801-585-2254    maryjane.tinnes@hsc.utah.edu   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Mark Drummond    206-520-4340    mjd520@u.washington.edu   
Sponsors and Collaborators
Vical
Investigators
Study Director: Mammen P Mammen, MD, FIDSA Vical
  More Information

Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT02837575     History of Changes
Other Study ID Numbers: HSV2-201
Study First Received: July 13, 2016
Last Updated: February 17, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Vical:
HSV-2
Genital Herpes
Herpes
Herpes Simplex Virus, Type 2

Additional relevant MeSH terms:
Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on March 29, 2017