A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

January 25, 2007 updated by: PowderMed

A Phase I Study to Assess Safety, Tolerability and Immunogenicity of a Trivalent Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) to 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.

Study Type

Interventional

Enrollment

189

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Quintiles Lenexa (QLX)
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Biokinetic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Ages Eligible for Study:

  • 18 Years - 50 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Healthy adult volunteers (women must be of non child-bearing potential)
  • Provided written informed consent

Exclusion Criteria:

  • No significant concomitant illness
  • No allergy to gold
  • No immunosuppression due to disease or treatment
  • No previous flu vaccination in 2005 or 2006

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety, tolerability and local reactogenicity - AEs and laboratory parameters

Secondary Outcome Measures

Outcome Measure
Immunogenicity of the vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PowderMed

Investigators

  • Principal Investigator: Philip Leese, MD, Quintiles, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 12, 2006

Study Record Updates

Last Update Posted (Estimate)

January 29, 2007

Last Update Submitted That Met QC Criteria

January 25, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM FLS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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