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Study of the Ability of a Flu Vaccine to Prevent Flu Infection

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ClinicalTrials.gov Identifier: NCT00349037
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : January 29, 2007
Sponsor:
Information provided by:
PowderMed

Brief Summary:
The purpose of this study is to evaluate how effective the vaccine is at preventing subjects developing flu symptoms after they are directly exposed to flu virus. The study will also 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

Condition or disease Intervention/treatment Phase
Influenza Biological: Trivalent DNA vaccine with and without pPJV2012 administered by PMED 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 will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for influenza as a potential alternative to existing vaccine technologies. This study will assess how effective two different PMED vaccine combinations are at preventing subjects developing influenza following exposure to flu virus 56 days after a single dose of vaccine.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Prospective, Randomised, Double Blind, Placebo-Controlled Study to Assess the Efficacy of a Trivalent (A/New Caledonia/20/99, A/Panama/2007/99, B/Jiangsu/10/20) DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) Against a Controlled Influenza Virus Challenge.
Study Start Date : September 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot




Primary Outcome Measures :
  1. Efficacy of the vaccine in preventing symptoms of influenza-like illness

Secondary Outcome Measures :
  1. Safety and tolerability - AEs and laboratory tests. 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
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

Pre-existing protective level of antibody against the challenge virus strain


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): NCT00349037


Locations
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United Kingdom
GDRU Quintiles Ltd
London, United Kingdom
Sponsors and Collaborators
PowderMed
Investigators
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Principal Investigator: Tim Mant, BSc, FRCP, FFPM GDRU
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ClinicalTrials.gov Identifier: NCT00349037    
Other Study ID Numbers: PM FLS-002
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: January 29, 2007
Last Verified: January 2007
Keywords provided by PowderMed:
DNA vaccine
influenza
immunogenicity
tolerability
PMED
efficacy
challenge virus
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases