---
title: Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
nct_id: NCT02030301
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Vical
study_type: INTERVENTIONAL
primary_condition: Genital Herpes Simplex Type 2
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02030301.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02030301"
ct_last_update_post_date: 2019-02-27
last_seen_at: "2026-05-12T06:29:23.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults

**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

**NCT ID:** [NCT02030301](https://clinicaltrials.gov/study/NCT02030301)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 165
- **Lead Sponsor:** Vical
- **Conditions:** Genital Herpes Simplex Type 2
- **Start Date:** 2013-12
- **Completion Date:** 2016-02
- **CT.gov Last Update:** 2019-02-27

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** ALL
- **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
```

## Arms

- **VCL-HB01, 0.25-mL dose** (EXPERIMENTAL) — VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
- **PBS, 0.25-mL dose** (PLACEBO_COMPARATOR) — PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
- **VCL-HB01, 0.5-mL dose** (EXPERIMENTAL) — VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
- **PBS, 0.5-mL dose** (PLACEBO_COMPARATOR) — PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
- **VCL-HB01, 1-mL dose** (EXPERIMENTAL) — VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
- **VCL-HM01, 1-mL dose** (EXPERIMENTAL) — VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
- **PBS, 1-mL dose** (PLACEBO_COMPARATOR) — PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses

## Interventions

- **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

- **Number of participants with adverse events** _(time frame: Up to Day 420)_
- **Viral shedding rate change from baseline** _(time frame: Baseline, Day 150)_

## Secondary Outcomes

- **Genital lesion rate change from baseline** _(time frame: Baseline, Day 150)_
- **HSV DNA copy numbers change from baseline** _(time frame: Baseline, Day 150)_
- **Genital recurrence rate compared with placebo** _(time frame: Up to Day 330)_
- **Subclinical genital shedding rate change from baseline** _(time frame: Up to Day 150)_
- **T-cell and/or antibody responses change from baseline** _(time frame: Baseline, Days 7, 35, 63, 150, 330)_

## Locations (7)

- Alabama Vaccine Research Clinic, Birmingham, Alabama, United States
- Broward Research Group, Hollywood, Florida, United States
- Indiana University Infectious Diseases Research, Indianapolis, Indiana, United States
- Westover Heights Clinic, Portland, Oregon, 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

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.alabama vaccine research clinic|birmingham|alabama|united states` — added _(2026-05-12)_
- `locations.broward research group|hollywood|florida|united states` — added _(2026-05-12)_
- `locations.indiana university infectious diseases research|indianapolis|indiana|united states` — added _(2026-05-12)_
- `locations.westover heights clinic|portland|oregon|united states` — added _(2026-05-12)_
- `locations.center for clinical studies|houston|texas|united states` — added _(2026-05-12)_
- `locations.university of utah - division of infectious diseases|salt lake city|utah|united states` — added _(2026-05-12)_
- `locations.university of washington medical center|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02030301.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02030301*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*