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

Phase 2

Completed

• Conditions: Herpes Genitalis
• Interventions: Biological: VCL-HB01; Other: Phosphate-buffered saline

• Registration Number: NCT02837575
• Lead Sponsor: Vical

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 Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Study Start: 2016-09
• Primary Completion: 2018-04
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VCL-HB01, 1-mL dose	VCL-HB01	VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses
Phosphate-buffered saline, 1-mL dose	Phosphate-buffered saline	PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses

Primary Outcome Measures

Name	Time	Method
Lesion recurrences	Up to Day 450

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects recurrence-free	Up to Day 450
Number of participants with adverse events	Up to Day 450
Time to first recurrence	Up to Day 450

Trial Locations

Locations (15)

QPS Broward Research; 🇺🇸 Hollywood, Florida, United States

Comprehensive Clinical Trials, LLC; 🇺🇸 West Palm Beach, Florida, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Heartland Research Associates, LLC; 🇺🇸 Wichita, Kansas, United States

Alabama Vaccine Research Clinic at University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Clinical Research Associates, Inc.; 🇺🇸 Nashville, Tennessee, United States

University of Utah School of Medicine - Division of Infectious Diseases; 🇺🇸 Salt Lake City, Utah, United States

QPS Miami Research Associates; 🇺🇸 South Miami, Florida, United States

Indiana University Infectious Disease Research; 🇺🇸 Indianapolis, Indiana, United States

Central Kentucky Research Associates, Inc.; 🇺🇸 Lexington, Kentucky, United States

Rochester Clinical Research, Inc.; 🇺🇸 Rochester, New York, United States

University of North Carolina (UNC) Institute of Global Health and Infectious Diseases; 🇺🇸 Chapel Hill, North Carolina, United States

The Center for Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States