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

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ClinicalTrials.gov Identifier: NCT00274300
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : January 29, 2007
Sponsor:
Information provided by:
PowderMed

Brief 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

Condition or disease Intervention/treatment Phase
HSV-2 Biological: pPJV7630 administered by PMED Phase 1

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 )

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adverse Events at all visits
  2. vaccine site evaluations
  3. laboratory parameters pre and post vaccination

Secondary Outcome Measures :
  1. HSV recurrences post vaccination
  2. immunogenicity of vaccine post vaccination


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00274300     History of Changes
Other Study ID Numbers: PJ HSV-001
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: January 29, 2007
Last Verified: January 2006

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

Additional relevant MeSH terms:
Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs