NCT02030301

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2013

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

December 20, 2013

Last Update Submit

February 25, 2019

Conditions

Genital Herpes Simplex Type 2

Keywords

Herpes Simplex Virus, Type 2HerpesHSV-2

Outcome Measures

Primary Outcomes (2)

  • Number of participants with adverse events

    Up to Day 420

  • Viral shedding rate change from baseline

    Baseline, Day 150

Secondary Outcomes (5)

  • Genital lesion rate change from baseline

    Baseline, Day 150

  • HSV DNA copy numbers change from baseline

    Baseline, Day 150

  • Genital recurrence rate compared with placebo

    Up to Day 330

  • Subclinical genital shedding rate change from baseline

    Up to Day 150

  • T-cell and/or antibody responses change from baseline

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

Other Outcomes (3)

  • Genital shedding rate change from baseline over time

    Baseline, Day 330

  • Genital lesion rate change from baseline

    Baseline, Day 330

  • Subclinical genital shedding rate change from baseline

    Baseline, Day 330

Study Arms (7)

VCL-HB01, 0.25-mL dose

EXPERIMENTAL

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

Biological: VCL-HB01

PBS, 0.25-mL dose

PLACEBO COMPARATOR

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

Biological: PBS

VCL-HB01, 0.5-mL dose

EXPERIMENTAL

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

Biological: VCL-HB01

PBS, 0.5-mL dose

PLACEBO COMPARATOR

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

Biological: PBS

VCL-HB01, 1-mL dose

EXPERIMENTAL

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

Biological: VCL-HB01

VCL-HM01, 1-mL dose

EXPERIMENTAL

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

Biological: VCL-HM01

PBS, 1-mL dose

PLACEBO COMPARATOR

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

Biological: PBS

Interventions

VCL-HB01BIOLOGICAL

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

VCL-HB01, 0.25-mL doseVCL-HB01, 0.5-mL doseVCL-HB01, 1-mL dose
VCL-HM01BIOLOGICAL

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

VCL-HM01, 1-mL dose
PBSBIOLOGICAL

Phosphate-buffered saline

PBS, 0.25-mL dosePBS, 0.5-mL dosePBS, 1-mL dose

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Alabama Vaccine Research Clinic

Birmingham, Alabama, 35294, United States

Location

Broward Research Group

Hollywood, Florida, 33024, United States

Location

Indiana University Infectious Diseases Research

Indianapolis, Indiana, 46202, United States

Location

Westover Heights Clinic

Portland, Oregon, 97210, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

University of Utah - Division of Infectious Diseases

Salt Lake City, Utah, 84132, United States

Location

University of Washington Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mammen P. Mammen, Jr., MD, FIDSA

    Vical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

January 8, 2014

Study Start

December 1, 2013

Primary Completion

June 1, 2015

Study Completion

February 1, 2016

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(7)