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

This study has been completed.
Sponsor:
Information provided by:
PowderMed
ClinicalTrials.gov Identifier:
NCT00274300
First received: January 9, 2006
Last updated: January 25, 2007
Last verified: January 2006
History of Changes

January 9, 2006
January 25, 2007
August 2004
Not Provided
  • Adverse Events at all visits
  • vaccine site evaluations
  • laboratory parameters pre and post vaccination
Same as current
Complete list of historical versions of study NCT00274300 on ClinicalTrials.gov Archive Site
  • HSV recurrences post vaccination
  • immunogenicity of vaccine post vaccination
Same as current
Not Provided
Not Provided
 
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
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

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

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 )
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HSV-2
Biological: pPJV7630 administered by PMED
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2005
Not Provided

Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00274300
PJ HSV-001
Not Provided
Not Provided
PowderMed
Not Provided
Principal Investigator: Larry Stanberry, MD, PhD University of Texas
PowderMed
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP