NCT02837575

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

15 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

First Submitted

Initial submission to the registry

July 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

July 13, 2016

Last Update Submit

February 25, 2019

Conditions

Herpes Genitalis

Keywords

HSV-2Genital HerpesHerpesHerpes Simplex Virus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Lesion recurrences

    Up to Day 450

Secondary Outcomes (3)

  • Number of participants with adverse events

    Up to Day 450

  • Time to first recurrence

    Up to Day 450

  • Proportion of subjects recurrence-free

    Up to Day 450

Study Arms (2)

VCL-HB01, 1-mL dose

EXPERIMENTAL

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

Biological: VCL-HB01

Phosphate-buffered saline, 1-mL dose

PLACEBO COMPARATOR

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

Other: Phosphate-buffered saline

Interventions

VCL-HB01BIOLOGICAL

Investigational Product

VCL-HB01, 1-mL dose
Phosphate-buffered salineOTHER

Placebo

Also known as: PBS
Phosphate-buffered saline, 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 with recurrences.

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 (15)

Alabama Vaccine Research Clinic at University of Alabama at Birmingham

Birmingham, Alabama, 35294-2050, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

QPS Broward Research

Hollywood, Florida, 33024, United States

Location

QPS Miami Research Associates

South Miami, Florida, 33143, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Indiana University Infectious Disease Research

Indianapolis, Indiana, 46202, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

University of North Carolina (UNC) Institute of Global Health and Infectious Diseases

Chapel Hill, North Carolina, 27599, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

University of Utah School of Medicine - Division of Infectious Diseases

Salt Lake City, Utah, 84132, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Herpes GenitalisHerpes Simplex

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mammen P Mammen, MD, FIDSA

    Vical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 19, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2018

Study Completion

December 1, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(15)