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Completed

NCT Number: NCT02030301

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

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Key information

Conditions

Genital Herpes Simplex Type 2 DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Alabama Vaccine Research Clinic, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VCL-HB01

Biological

Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®

VCL-HM01

Biological

Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®

PBS

Biological

Phosphate-buffered saline

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Up to Day 420

  2. Viral shedding rate change from baseline

    Time frame: Baseline, Day 150

Secondary outcomes

  1. Genital lesion rate change from baseline

    Time frame: Baseline, Day 150

  2. HSV DNA copy numbers change from baseline

    Time frame: Baseline, Day 150

  3. Genital recurrence rate compared with placebo

    Time frame: Up to Day 330

  4. Subclinical genital shedding rate change from baseline

    Time frame: Up to Day 150

  5. T-cell and/or antibody responses change from baseline

    Time frame: Baseline, Days 7, 35, 63, 150, 330

Other outcomes

  1. Genital shedding rate change from baseline over time

    Time frame: Baseline, Day 330

  2. Genital lesion rate change from baseline

    Time frame: Baseline, Day 330

  3. Subclinical genital shedding rate change from baseline

    Time frame: Baseline, Day 330

Sponsors and collaborators

Lead sponsor

Vical

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 8, 2014
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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