Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
Primary Purpose
Influenza (Pandemic)
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
pPML7789 with and without pPJV2012 administered by PMED
Sponsored by
About this trial
This is an interventional prevention trial for Influenza (Pandemic) focused on measuring DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
Eligibility 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
Sites / Locations
- Guys Research Drug Unit, Quintiles Ltd.
Outcomes
Primary Outcome Measures
Safety, tolerability and local reactogenicity-AEs and laboratory parameters.
Secondary Outcome Measures
Immunogenicity of the vaccine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00347529
Brief Title
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
PowderMed
4. Oversight
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza (Pandemic)
Keywords
DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
pPML7789 with and without pPJV2012 administered by PMED
Primary Outcome Measure Information:
Title
Safety, tolerability and local reactogenicity-AEs and laboratory parameters.
Secondary Outcome Measure Information:
Title
Immunogenicity of the vaccine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Mant, BSc, FRCP, FFPM
Organizational Affiliation
Guys Research Drug Unit, Quintiles UK Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guys Research Drug Unit, Quintiles Ltd.
City
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
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