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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vical
ClinicalTrials.gov Identifier:
NCT02030301
First received: December 20, 2013
Last updated: March 9, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Genital Herpes Simplex Type 2
Biological: VCL-HB01
Biological: VCL-HM01
Biological: PBS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Vical:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to Day 420 ] [ Designated as safety issue: Yes ]
  • Viral shedding rate change from baseline [ Time Frame: Baseline, Day 150 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Genital lesion rate change from baseline [ Time Frame: Baseline, Day 150 ] [ Designated as safety issue: No ]
  • HSV DNA copy numbers change from baseline [ Time Frame: Baseline, Day 150 ] [ Designated as safety issue: No ]
  • Genital recurrence rate compared with placebo [ Time Frame: Up to Day 330 ] [ Designated as safety issue: No ]
  • T-cell and/or antibody responses change from baseline [ Time Frame: Baseline, Days 7, 35, 63, 150, 330 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Genital shedding rate change from baseline over time [ Time Frame: Baseline, Day 150, Day 330 ] [ Designated as safety issue: No ]
  • Subclinical genital shedding rate change from baseline [ Time Frame: Baseline, Day 150 ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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: NCT02030301

Locations
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
Study Director: Mammen P. Mammen, Jr., MD,FACP,FIDSA Vical
  More Information

No publications provided

Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT02030301     History of Changes
Other Study ID Numbers: HSV2-101
Study First Received: December 20, 2013
Last Updated: March 9, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 30, 2015