A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375206
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : January 29, 2007
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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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012) Phase 1

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  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2006
Estimated Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety, tolerability and local reactogenicity - AEs and laboratory parameters

Secondary Outcome Measures :
  1. Immunogenicity of the vaccine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Ages Eligible for Study:

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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375206

United States, Kansas
Quintiles Lenexa (QLX)
Lenexa, Kansas, United States, 66219
United States, Missouri
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Principal Investigator: Philip Leese, MD Quintiles, Inc. Identifier: NCT00375206     History of Changes
Other Study ID Numbers: PM FLS-001
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: January 29, 2007
Last Verified: January 2007

Keywords provided by PowderMed:
PowderMed, DNA vaccine, influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs