Trials / Completed
CompletedNCT00274300
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (planned)
- Sponsor
- PowderMed · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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 )
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pPJV7630 administered by PMED |
Timeline
- Start date
- 2004-08-01
- Completion
- 2005-07-01
- First posted
- 2006-01-10
- Last updated
- 2007-01-29
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00274300. Inclusion in this directory is not an endorsement.