NCT00310271

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

November 21, 2008

Status Verified

November 1, 2008

First QC Date

March 31, 2006

Last Update Submit

November 20, 2008

Conditions

HSV-2

Keywords

DNA vaccine, immunotherapy, HSV-2, PMED

Outcome Measures

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

Interventions

pPJV7630 with pPJV2012 administered by PMEDBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Otherwise healthy subjects with seronegative HSV-2

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

Sponsors & Collaborators

Study Sites (1)

CPC Phase I Unit

Lenexa, Kansas, 66219, United States

Location

Study Officials

  • Steven Komjathy, MD

    PRA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 3, 2006

Study Start

April 1, 2006

Study Completion

December 1, 2006

Last Updated

November 21, 2008

Record last verified: 2008-11

Locations

US(1)