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

Primary Purpose

Genital Herpes Simplex Type 2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VCL-HB01

VCL-HM01

PBS

About this trial

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

Sites / Locations

Alabama Vaccine Research Clinic
Broward Research Group
Indiana University Infectious Diseases Research
Westover Heights Clinic
Center for Clinical Studies
University of Utah - Division of Infectious Diseases
University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

VCL-HB01, 0.25-mL dose

PBS, 0.25-mL dose

VCL-HB01, 0.5-mL dose

PBS, 0.5-mL dose

VCL-HB01, 1-mL dose

VCL-HM01, 1-mL dose

PBS, 1-mL dose

Arm Description

VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses

PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses

VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses

PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses

VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses

VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses

PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Viral shedding rate change from baseline

Secondary Outcome Measures

Genital lesion rate change from baseline

HSV DNA copy numbers change from baseline

Genital recurrence rate compared with placebo

Subclinical genital shedding rate change from baseline

T-cell and/or antibody responses change from baseline

Full Information

NCT ID

NCT02030301

First Posted

December 20, 2013

Last Updated

February 25, 2019

Sponsor

Vical

1. Study Identification

Unique Protocol Identification Number

NCT02030301

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Genital Herpes Simplex Type 2

Keywords

Herpes Simplex Virus, Type 2, Herpes, HSV-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VCL-HB01, 0.25-mL dose

Arm Type

Experimental

Arm Description

VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses

Arm Title

PBS, 0.25-mL dose

Arm Type

Placebo Comparator

Arm Description

PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses

Arm Title

VCL-HB01, 0.5-mL dose

Arm Type

Experimental

Arm Description

VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses

Arm Title

PBS, 0.5-mL dose

Arm Type

Placebo Comparator

Arm Description

PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses

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 3 doses

Arm Title

VCL-HM01, 1-mL dose

Arm Type

Experimental

Arm Description

VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses

Arm Title

PBS, 1-mL dose

Arm Type

Placebo Comparator

Arm Description

PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses

Intervention Type

Biological

Intervention Name(s)

VCL-HB01

Intervention Description

Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®

Intervention Type

Biological

Intervention Name(s)

VCL-HM01

Intervention Description

Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®

Intervention Type

Biological

Intervention Name(s)

PBS

Intervention Description

Phosphate-buffered saline

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

Up to Day 420

Title

Viral shedding rate change from baseline

Time Frame

Baseline, Day 150

Secondary Outcome Measure Information:

Title

Genital lesion rate change from baseline

Time Frame

Baseline, Day 150

Title

HSV DNA copy numbers change from baseline

Time Frame

Baseline, Day 150

Title

Genital recurrence rate compared with placebo

Time Frame

Up to Day 330

Title

Subclinical genital shedding rate change from baseline

Time Frame

Up to Day 150

Title

T-cell and/or antibody responses change from baseline

Time Frame

Baseline, Days 7, 35, 63, 150, 330

Other Pre-specified Outcome Measures:

Title

Genital shedding rate change from baseline over time

Time Frame

Baseline, Day 330

Title

Genital lesion rate change from baseline

Time Frame

Baseline, Day 330

Title

Subclinical genital shedding rate change from baseline

Time Frame

Baseline, Day 330

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mammen P. Mammen, Jr., MD, FIDSA

Organizational Affiliation

Vical

Official's Role

Study Director

Facility Information:

Facility Name

Alabama Vaccine Research Clinic

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Broward Research Group

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Indiana University Infectious Diseases Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Westover Heights Clinic

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Center for Clinical Studies

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

University of Utah - Division of Infectious Diseases

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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