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Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00347529
First Posted: July 4, 2006
Last Update Posted: January 29, 2007
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.
Information provided by:
PowderMed
  Purpose
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu

Condition Intervention Phase
Influenza (Pandemic) Biological: pPML7789 with and without pPJV2012 administered by PMED Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomised Double Blind Dose-Ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine (A Vietnam/1194/2004) Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults

Resource links provided by NLM:


Further study details as provided by PowderMed:

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

Secondary Outcome Measures:
  • Immunogenicity of the vaccine

Estimated Enrollment: 75
Study Start Date: August 2006
Estimated Study Completion Date: January 2007
Detailed Description:
Pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. Some pandemics can have very severe health impacts and be widespread. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as a potential alternative to other vaccine technologies. This study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. The vaccine will be given as a prime-boost regimen with vaccination on Days 0 and 28
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent

Exclusion Criteria:

No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00347529


Locations
United Kingdom
Guys Research Drug Unit, Quintiles Ltd.
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
PowderMed
Investigators
Principal Investigator: Tim Mant, BSc, FRCP, FFPM Guys Research Drug Unit, Quintiles UK Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT00347529     History of Changes
Other Study ID Numbers: PM FLP-001
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: January 29, 2007
Last Verified: January 2007

Keywords provided by PowderMed:
DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic

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