Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2

HSV-2 Clinical Trial

Official title:

A Phase I, Two-Center, Open-Label, Dose-Escalating Study to Investigate the Safety, Tolerability and Immunogenicity of pPJV7630, a Therapeutic DNA Vaccine for Herpes Simplex Virus Type 2 (HSV-2), in Patients With Recurrent Genital Herpes Caused by HSV-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274300
• Other study ID #: PJ HSV-001
• 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
• 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

• Herpes Genitalis
• HSV-2

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