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

NCT ID: NCT00310271

Last Updated: 2008-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-12-31

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 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)

Conditions

HSV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

pPJV7630 with pPJV2012 administered by PMED

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Otherwise healthy subjects with seronegative HSV-2

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PowderMed

INDUSTRY

Sponsor Role: lead

Principal Investigators

Steven Komjathy, MD

Role: PRINCIPAL_INVESTIGATOR

PRA

Locations

CPC Phase I Unit

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

PM HSD-001 P

Identifier Type: -

Identifier Source: org_study_id