Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310271
Status:
COMPLETED
Last Update Posted:
2008-11-21
First Post:
2006-03-31
Brief Title:
A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects
Sponsor:
PowderMed
Organization:
PowderMed
Study Overview
Official Title:
A Phase I Study Assessing Safety and Tolerability of a DNA Vaccine With a DNA Encoded Immunostimulator Administered by Particle Mediated Epidermal Delivery Using the PowderMed ND10 Delivery System in HSV-2 Seronegative Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2008-11
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
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 a therapeutic DNA vaccine pPJV7630 in combination with a DNA encoded immunostimulator pPJV2012 when 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