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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.
 
ClinicalTrials.gov Identifier: NCT00375206
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : January 29, 2007
Sponsor:
Information provided by:
PowderMed

Tracking Information
First Submitted Date  ICMJE September 11, 2006
First Posted Date  ICMJE September 12, 2006
Last Update Posted Date January 29, 2007
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2006)		 Safety, tolerability and local reactogenicity - AEs and laboratory parameters
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2006)		 Immunogenicity of the vaccine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 11, 2006)		 189
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00375206
Other Study ID Numbers  ICMJE PM FLS-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE PowderMed
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Leese, MD Quintiles, Inc.
PRS Account PowderMed
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP