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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
  Purpose

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


Condition Intervention Phase
HSV-2
Biological: pPJV7630 administered by PMED
Phase 1

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

Resource links provided by NLM:


Further study details as provided by PowderMed:

Primary Outcome Measures:
  • Adverse Events at all visits
  • vaccine site evaluations
  • laboratory parameters pre and post vaccination

Secondary Outcome Measures:
  • HSV recurrences post vaccination
  • immunogenicity of vaccine post vaccination

Estimated Enrollment: 36
Study Start Date: August 2004
Estimated Study Completion Date: July 2005
Detailed 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 )

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274300

Locations
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Texas
Center for Clinical Studies
Houston, Texas, United States, 77058
Sponsors and Collaborators
PowderMed
Investigators
Principal Investigator: Larry Stanberry, MD, PhD University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00274300     History of Changes
Other Study ID Numbers: PJ HSV-001
Study First Received: January 9, 2006
Last Updated: January 25, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by PowderMed:
DNA vaccine
immunotherapy
Herpes Simplex Virus Type 2 (HSV2)
Particle Mediated Epidermal Delivery

Additional relevant MeSH terms:
Herpes Genitalis
DNA Virus Infections
Genital Diseases, Female
Genital Diseases, Male
Herpes Simplex
Herpesviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014