Back to resultsSafety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
Primary Purpose
HSV-2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pPJV7630 administered by PMED
Sponsored by
About this trial
This is an interventional treatment trial for HSV-2 focused on measuring DNA vaccine, immunotherapy, Herpes Simplex Virus Type 2 (HSV2), Particle Mediated Epidermal Delivery
Eligibility Criteria
Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection
Sites / Locations
- Westover Heights Clinic
- Center for Clinical Studies
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00274300
Brief Title
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
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 Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
PowderMed
4. Oversight
5. Study Description
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
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 )
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HSV-2
Keywords
DNA vaccine, immunotherapy, Herpes Simplex Virus Type 2 (HSV2), Particle Mediated Epidermal Delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
pPJV7630 administered by PMED
Primary Outcome Measure Information:
Title
Adverse Events at all visits
Title
vaccine site evaluations
Title
laboratory parameters pre and post vaccination
Secondary Outcome Measure Information:
Title
HSV recurrences post vaccination
Title
immunogenicity of vaccine post vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Stanberry, MD, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
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