Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274300
Status:
COMPLETED
Last Update Posted:
2007-01-29
First Post:
2006-01-09
Brief Title:
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
Sponsor:
PowderMed
Organization:
PowderMed
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infectionThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None