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

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 I

MedlinePlus related topics:

Herpes Simplex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

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

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

Study ID Numbers:	PJ HSV-001
First Received:	January 9, 2006
Last Updated:	January 25, 2007
ClinicalTrials.gov Identifier:	NCT00274300
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

Study placed in the following topic categories:

Genital Diseases, Female

Virus Diseases

Herpes Simplex

Sexually Transmitted Diseases, Viral

Herpes Genitalis

Sexually Transmitted Diseases

DNA Virus Infections

Genital Diseases, Male

Recurrence

Herpesviridae Infections

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	PowderMed
Information provided by:	PowderMed
ClinicalTrials.gov Identifier:	NCT00274300