Skip to main content
OpenTrials
Completed

NCT Number: NCT00310271

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HSV-2

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CPC Phase I Unit

Lenexa, Kansas, 66219, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Otherwise healthy subjects with seronegative HSV-2

Treatment and study plan

pPJV7630 with pPJV2012 administered by PMED

Biological

Primary outcomes

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

Secondary outcomes

  1. immunogenicity of vaccine post vaccination

Sponsors and collaborators

Lead sponsor

PowderMed

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2006
First posted
Apr 3, 2006
Registry last updated
Nov 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.