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

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ClinicalTrials.gov Identifier: NCT02837575
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Vical

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Herpes Genitalis Biological: VCL-HB01 Other: Phosphate-buffered saline Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : September 2016
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: PBS


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

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to Day 450 ]
  2. Time to first recurrence [ Time Frame: Up to Day 450 ]
  3. Proportion of subjects recurrence-free [ Time Frame: Up to Day 450 ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837575


Locations
United States, Alabama
Alabama Vaccine Research Clinic at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2050
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
United States, Florida
QPS Broward Research
Hollywood, Florida, United States, 33024
QPS Miami Research Associates
South Miami, Florida, United States, 33143
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States, 33409
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Infectious Disease Research
Indianapolis, Indiana, United States, 46202
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, North Carolina
University of North Carolina (UNC) Institute of Global Health and Infectious Diseases
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Utah
University of Utah School of Medicine - Division of Infectious Diseases
Salt Lake City, Utah, United States, 84132
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Vical
Investigators
Study Director: Mammen P Mammen, MD, FIDSA Vical
More Information
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Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT02837575     History of Changes
Other Study ID Numbers: HSV2-201
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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