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Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02030301
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Vical

Study Description
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Brief Summary:
The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).

Condition or disease Intervention/treatment Phase
Genital Herpes Simplex Type 2 Biological: VCL-HB01 Biological: VCL-HM01 Biological: PBS Phase 1 Phase 2

Detailed Description:
This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3 doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive therapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults
Study Start Date : December 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : February 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: VCL-HB01, 0.25-mL dose
VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
 Biological: VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Placebo Comparator: PBS, 0.25-mL dose
PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
 Biological: PBS
Phosphate-buffered saline
Experimental: VCL-HB01, 0.5-mL dose
VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
 Biological: VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Placebo Comparator: PBS, 0.5-mL dose
PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
 Biological: PBS
Phosphate-buffered saline
Experimental: VCL-HB01, 1-mL dose
VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
 Biological: VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Experimental: VCL-HM01, 1-mL dose
VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
 Biological: VCL-HM01
Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
Placebo Comparator: PBS, 1-mL dose
PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses
 Biological: PBS
Phosphate-buffered saline


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to Day 420 ]
  2. Viral shedding rate change from baseline [ Time Frame: Baseline, Day 150 ]

Secondary Outcome Measures :
  1. Genital lesion rate change from baseline [ Time Frame: Baseline, Day 150 ]
  2. HSV DNA copy numbers change from baseline [ Time Frame: Baseline, Day 150 ]
  3. Genital recurrence rate compared with placebo [ Time Frame: Up to Day 330 ]
  4. Subclinical genital shedding rate change from baseline [ Time Frame: Up to Day 150 ]
  5. T-cell and/or antibody responses change from baseline [ Time Frame: Baseline, Days 7, 35, 63, 150, 330 ]

Other Outcome Measures:
  1. Genital shedding rate change from baseline over time [ Time Frame: Baseline, Day 330 ]
  2. Genital lesion rate change from baseline [ Time Frame: Baseline, Day 330 ]
  3. Subclinical genital shedding rate change from baseline [ Time Frame: Baseline, Day 330 ]

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 and either 2 to 9 recurrences within the year prior to screening or 2 to 9 recurrences per year prior to starting suppressive therapy

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): NCT02030301


Locations
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United States, Alabama
Alabama Vaccine Research Clinic
Birmingham, Alabama, United States, 35294
United States, Florida
Broward Research Group
Hollywood, Florida, United States, 33024
United States, Indiana
Indiana University Infectious Diseases Research
Indianapolis, Indiana, United States, 46202
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Texas
Center for Clinical Studies
Houston, Texas, United States, 77004
United States, Utah
University of Utah - Division of Infectious Diseases
Salt Lake City, Utah, United States, 84132
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Vical
Investigators
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Study Director: Mammen P. Mammen, Jr., MD, FIDSA Vical
More Information
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Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT02030301    
Other Study ID Numbers: HSV2-101
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vical:
Herpes Simplex Virus, Type 2
Herpes
HSV-2
Additional relevant MeSH terms:
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Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
 Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases