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

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

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).

Study Overview

• Status: Completed
• Conditions: Genital Herpes Simplex Type 2
• Intervention / Treatment: Biological: VCL-HB01; Biological: PBS; Biological: VCL-HM01

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.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Alabama Vaccine Research Clinic
  • Florida
    • Hollywood, Florida, United States, 33024
      • Broward Research Group
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Infectious Diseases Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Westover Heights Clinic
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah - Division of Infectious Diseases
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VCL-HB01, 0.25-mL dose; VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses	Biological: VCL-HB01; Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Placebo Comparator: PBS, 0.25-mL dose; PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses	Biological: PBS; Phosphate-buffered saline
Experimental: VCL-HB01, 0.5-mL dose; VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses	Biological: VCL-HB01; Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Placebo Comparator: PBS, 0.5-mL dose; PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses	Biological: PBS; Phosphate-buffered saline
Experimental: VCL-HB01, 1-mL dose; VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses	Biological: VCL-HB01; Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Experimental: VCL-HM01, 1-mL dose; VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses	Biological: VCL-HM01; Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
Placebo Comparator: PBS, 1-mL dose; PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses	Biological: PBS; Phosphate-buffered saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Up to Day 420
Viral shedding rate change from baseline	Baseline, Day 150

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vical
• Investigators: Study Director: Mammen P. Mammen, Jr., MD, FIDSA, Vical

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 20, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: HSV-2; Herpes Simplex Virus, Type 2; Herpes
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex; Herpes Genitalis
• Other Study ID Numbers: HSV2-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No