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

• Sponsor: PowderMed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00310271
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HSV-2	Biological: pPJV7630 with pPJV2012 administered by PMED	Phase 1

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)

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Apr 1, 2006
• Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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

1. immunogenicity of vaccine post vaccination []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Otherwise healthy subjects with seronegative HSV-2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CPC Phase I Unit	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• PowderMed

Investigators

• Principal Investigator: Steven Komjathy, MD, PRA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00310271
• Other Study ID Numbers: PM HSD-001 P
• First Posted: Apr 3, 2006
• Last Update Posted: Nov 21, 2008
• Last Verified: Nov 1, 2008

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

Study Results

No Results Posted as of Nov 21, 2008