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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02030301

Enrollment

165

Registered

2014-01-08

Start date

2013-12-31

Completion date

2016-02-29

Last updated

2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Herpes Simplex Type 2

Keywords

Herpes Simplex Virus, Type 2, Herpes, HSV-2

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.

Interventions

BIOLOGICALVCL-HB01

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

BIOLOGICALVCL-HM01

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

BIOLOGICALPBS

Phosphate-buffered saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
HSV DNA copy numbers change from baseline	Baseline, Day 150
Genital recurrence rate compared with placebo	Up to Day 330
Genital lesion rate change from baseline	Baseline, Day 150
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

Measure	Time frame
Genital lesion rate change from baseline	Baseline, Day 330
Genital shedding rate change from baseline over time	Baseline, Day 330
Subclinical genital shedding rate change from baseline	Baseline, Day 330

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026