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Trial record 9 of 126 for:    HSV-2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274300
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : January 29, 2007
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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 )

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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

MedlinePlus related topics: Genital Herpes

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

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 identifier (NCT number): NCT00274300

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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
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Principal Investigator: Larry Stanberry, MD, PhD University of Texas

Layout table for additonal information 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
Herpes Simplex Virus Type 2 (HSV2)
Particle Mediated Epidermal Delivery
Additional relevant MeSH terms:
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Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs