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

Genital Herpes Simplex Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030301
• Other study ID #: HSV2-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2019
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Herpes Simplex Type 2
• Herpes Genitalis
• Herpes Simplex

Intervention

Biological:
• VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
• VCL-HM01
Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
• PBS
Phosphate-buffered saline

Locations

Country	Name	City	State
United States	Alabama Vaccine Research Clinic	Birmingham	Alabama
United States	Broward Research Group	Hollywood	Florida
United States	Center for Clinical Studies	Houston	Texas
United States	Indiana University Infectious Diseases Research	Indianapolis	Indiana
United States	Westover Heights Clinic	Portland	Oregon
United States	University of Utah - Division of Infectious Diseases	Salt Lake City	Utah
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genital shedding rate change from baseline over time		Baseline, Day 330
Other	Genital lesion rate change from baseline		Baseline, Day 330
Other	Subclinical genital shedding rate change from baseline		Baseline, Day 330
Primary	Number of participants with adverse events		Up to Day 420
Primary	Viral shedding rate change from baseline		Baseline, Day 150
Secondary	Genital lesion rate change from baseline		Baseline, Day 150
Secondary	HSV DNA copy numbers change from baseline		Baseline, Day 150
Secondary	Genital recurrence rate compared with placebo		Up to Day 330
Secondary	Subclinical genital shedding rate change from baseline		Up to Day 150
Secondary	T-cell and/or antibody responses change from baseline		Baseline, Days 7, 35, 63, 150, 330