NCT00274300

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 and evaluate the effect it has on herpes outbreaks

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

January 29, 2007

Status Verified

January 1, 2006

First QC Date

January 9, 2006

Last Update Submit

January 25, 2007

Conditions

HSV-2

Keywords

DNA vaccineimmunotherapyHerpes Simplex Virus Type 2 (HSV2)Particle Mediated Epidermal Delivery

Outcome Measures

Primary Outcomes (3)

  • Adverse Events at all visits

  • vaccine site evaluations

  • laboratory parameters pre and post vaccination

Secondary Outcomes (2)

  • HSV recurrences post vaccination

  • immunogenicity of vaccine post vaccination

Interventions

pPJV7630 administered by PMEDBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Westover Heights Clinic

Portland, Oregon, 97210, United States

Location

Center for Clinical Studies

Houston, Texas, 77058, United States

Location

Study Officials

  • Larry Stanberry, MD, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

August 1, 2004

Study Completion

July 1, 2005

Last Updated

January 29, 2007

Record last verified: 2006-01

Locations

US(2)