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

Phase 1

Completed

• Conditions: Genital Herpes Simplex Type 2
• Interventions: Biological: PBS; Biological: VCL-HB01; Biological: VCL-HM01

• Registration Number: NCT02030301
• Lead Sponsor: Vical

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Primary Completion: 2015-06
• Study Completion: 2016-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBS, 0.5-mL dose	PBS	PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
VCL-HB01, 0.5-mL dose	VCL-HB01	VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
PBS, 0.25-mL dose	PBS	PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
VCL-HB01, 1-mL dose	VCL-HB01	VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
VCL-HM01, 1-mL dose	VCL-HM01	VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
VCL-HB01, 0.25-mL dose	VCL-HB01	VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
PBS, 1-mL dose	PBS	PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Alabama Vaccine Research Clinic; 🇺🇸 Birmingham, Alabama, United States

Westover Heights Clinic; 🇺🇸 Portland, Oregon, United States

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

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

Center for Clinical Studies; 🇺🇸 Houston, Texas, United States

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

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