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

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: NCT02837575
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Vical

Tracking Information
First Submitted Date  ICMJE July 13, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date February 27, 2019
Study Start Date  ICMJE September 2016
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
Lesion recurrences [ Time Frame: Up to Day 450 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
Lesion recurrences [ Time Frame: Up to Day 270 ]
Change History Complete list of historical versions of study NCT02837575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Number of participants with adverse events [ Time Frame: Up to Day 450 ]
  • Proportion of subjects recurrence-free [ Time Frame: Up to Day 450 ]
  • T-cell response change from base line for a subset of subjects as measured by interferon-gamma ELISPOT assay [ Time Frame: Baseline, Days 35, 63, 91, 180 and 450 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
Official Title  ICMJE 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
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Herpes Genitalis
Intervention  ICMJE
  • Biological: VCL-HB01
    Investigational Product
  • Other: Phosphate-buffered saline
    Placebo
    Other Name: PBS
Study Arms  ICMJE
  • Experimental: VCL-HB01, 1-mL dose
    VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses
    Intervention: Biological: VCL-HB01
  • Placebo Comparator: Phosphate-buffered saline, 1-mL dose
    PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses
    Intervention: Other: Phosphate-buffered saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2017)
261
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2016)
225
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02837575
Other Study ID Numbers  ICMJE HSV2-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vical
Study Sponsor  ICMJE Vical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mammen P Mammen, MD, FIDSA Vical
PRS Account Vical
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP