A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects - Full Text View

Sponsored by:	PowderMed
Information provided by:	PowderMed
ClinicalTrials.gov Identifier:	NCT00310271

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.

Condition	Intervention	Phase
HSV-2	Biological: pPJV7630 with pPJV2012 administered by PMED	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
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

Further study details as provided by PowderMed:

Primary Outcome Measures:

Safety, tolerability and reactogenicity of the investigational product as determined by AEs and evaluation of the site of vaccination at each visit.

Secondary Outcome Measures:

immunogenicity of vaccine post vaccination

Estimated Enrollment:	42
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2006

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 a therapeutic DNA vaccine (pPJV7630) in combination with a DNA encoded immunostimulator (pPJV2012) when 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:	Yes

Criteria

Otherwise healthy subjects with seronegative HSV-2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310271

Locations

United States, Kansas
CPC Phase I Unit
Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

PowderMed

Investigators

Principal Investigator:

Steven Komjathy, MD

PRA

More Information

No publications provided

Study ID Numbers:	PM HSD-001 P
Study First Received:	March 31, 2006
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00310271 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by PowderMed:

DNA vaccine, immunotherapy, HSV-2, PMED

Study placed in the following topic categories:

Sennoside A&B
Senna Extract
Healthy

ClinicalTrials.gov processed this record on May 07, 2009