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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00274300
Other study ID # PJ HSV-001
Secondary ID
Status Completed
Phase Phase 1
First received January 9, 2006
Last updated January 25, 2007
Start date August 2004
Est. completion date July 2005

Study information

Verified date January 2006
Source PowderMed
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body and evaluate the effect it has on herpes outbreaks


Description:

Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of the pPJV7630 HSV-2 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
pPJV7630 administered by PMED


Locations

Country Name City State
United States Center for Clinical Studies Houston Texas
United States Westover Heights Clinic Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
PowderMed

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events at all visits
Primary vaccine site evaluations
Primary laboratory parameters pre and post vaccination
Secondary HSV recurrences post vaccination
Secondary immunogenicity of vaccine post vaccination
See also
  Status Clinical Trial Phase
Completed NCT01047540 - Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2 Phase 2
Recruiting NCT01108614 - Injecting Drug Use Community Intervention Trial Phase 3
Completed NCT00803543 - Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daily Valacyclovir in the Reduction of HSV-2 Recurrence and Viral Shedding N/A
Completed NCT00310271 - A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects Phase 1