Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02837575

Acronym

HSV-2

Enrollment

261

Registered

2016-07-19

Start date

2016-09-30

Completion date

2018-12-31

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

Herpes Genitalis

Keywords

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

Brief summary

The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).

Detailed description

To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.

Interventions

BIOLOGICALVCL-HB01

Investigational Product

OTHERPhosphate-buffered saline

Placebo

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 with recurrences.

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
Lesion recurrences	Up to Day 450

Secondary

Measure	Time frame
Number of participants with adverse events	Up to Day 450
Time to first recurrence	Up to Day 450
Proportion of subjects recurrence-free	Up to Day 450

Countries

United States

Outcome results

None listed

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