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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310271
First Posted: April 3, 2006
Last Update Posted: November 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
PowderMed
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Otherwise healthy subjects with seronegative HSV-2
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00310271     History of Changes
Other Study ID Numbers: PM HSD-001 P
First Submitted: March 31, 2006
First Posted: April 3, 2006
Last Update Posted: November 21, 2008
Last Verified: November 2008

Keywords provided by PowderMed:
DNA vaccine, immunotherapy, HSV-2, PMED

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs