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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-07-31

Brief Summary

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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

Detailed Description

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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 )

Conditions

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HSV-2

Keywords

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DNA vaccine immunotherapy Herpes Simplex Virus Type 2 (HSV2) Particle Mediated Epidermal Delivery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pPJV7630 administered by PMED

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Larry Stanberry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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Westover Heights Clinic

Portland, Oregon, United States

Site Status

Center for Clinical Studies

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PJ HSV-001

Identifier Type: -

Identifier Source: org_study_id