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

Primary Purpose

Herpes Genitalis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VCL-HB01
Phosphate-buffered saline
Sponsored by
Vical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Genitalis focused on measuring HSV-2, Genital Herpes, Herpes, Herpes Simplex Virus, Type 2

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alabama Vaccine Research Clinic at University of Alabama at Birmingham
  • Medical Center for Clinical Research
  • QPS Broward Research
  • QPS Miami Research Associates
  • Comprehensive Clinical Trials, LLC
  • University of Illinois
  • Indiana University Infectious Disease Research
  • Heartland Research Associates, LLC
  • Central Kentucky Research Associates, Inc.
  • The Center for Pharmaceutical Research
  • Rochester Clinical Research, Inc.
  • University of North Carolina (UNC) Institute of Global Health and Infectious Diseases
  • Clinical Research Associates, Inc.
  • University of Utah School of Medicine - Division of Infectious Diseases
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VCL-HB01, 1-mL dose

Phosphate-buffered saline, 1-mL dose

Arm Description

VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses

PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses

Outcomes

Primary Outcome Measures

Lesion recurrences

Secondary Outcome Measures

Number of participants with adverse events
Time to first recurrence
Proportion of subjects recurrence-free

Full Information

First Posted
July 13, 2016
Last Updated
February 25, 2019
Sponsor
Vical
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1. Study Identification

Unique Protocol Identification Number
NCT02837575
Brief Title
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
Acronym
HSV-2
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Genitalis
Keywords
HSV-2, Genital Herpes, Herpes, Herpes Simplex Virus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VCL-HB01, 1-mL dose
Arm Type
Experimental
Arm Description
VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses
Arm Title
Phosphate-buffered saline, 1-mL dose
Arm Type
Placebo Comparator
Arm Description
PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses
Intervention Type
Biological
Intervention Name(s)
VCL-HB01
Intervention Description
Investigational Product
Intervention Type
Other
Intervention Name(s)
Phosphate-buffered saline
Other Intervention Name(s)
PBS
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Lesion recurrences
Time Frame
Up to Day 450
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
Up to Day 450
Title
Time to first recurrence
Time Frame
Up to Day 450
Title
Proportion of subjects recurrence-free
Time Frame
Up to Day 450

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mammen P Mammen, MD, FIDSA
Organizational Affiliation
Vical
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Vaccine Research Clinic at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2050
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
QPS Broward Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
QPS Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Infectious Disease Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
University of North Carolina (UNC) Institute of Global Health and Infectious Diseases
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Utah School of Medicine - Division of Infectious Diseases
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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