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OpenTrials
Completed

NCT Number: NCT00274300

Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2

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 and evaluate the effect it has on herpes outbreaks

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Key information

Conditions

HSV-2

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Westover Heights Clinic, Portland, Oregon, United States

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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 the pPJV7630 HSV-2 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )

Who can participate

Healthy volunteers accepted: No

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

Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection

Treatment and study plan

pPJV7630 administered by PMED

Biological

Primary outcomes

  1. Adverse Events at all visits

  2. vaccine site evaluations

  3. laboratory parameters pre and post vaccination

Secondary outcomes

  1. HSV recurrences post vaccination

  2. immunogenicity of vaccine post vaccination

Sponsors and collaborators

Lead sponsor

PowderMed

Industry

Registry information

Official study title

A Phase I, Two-Center, Open-Label, Dose-Escalating Study to Investigate the Safety, Tolerability and Immunogenicity of pPJV7630, a Therapeutic DNA Vaccine for Herpes Simplex Virus Type 2 (HSV-2), in Patients With Recurrent Genital Herpes Caused by HSV-2

Important dates

Study start
2004
Study completion
2005
First posted
Jan 10, 2006
Registry last updated
Jan 29, 2007

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.

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