Study of the Ability of a Flu Vaccine to Prevent Flu Infection
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Trivalent DNA vaccine with and without pPJV2012 administered by PMED
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring DNA vaccine, influenza, immunogenicity, tolerability, PMED, efficacy, challenge virus
Eligibility 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
Sites / Locations
- GDRU Quintiles Ltd
Outcomes
Primary Outcome Measures
Efficacy of the vaccine in preventing symptoms of influenza-like illness
Secondary Outcome Measures
Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349037
Brief Title
Study of the Ability of a Flu Vaccine to Prevent Flu Infection
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 Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
September 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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
DNA vaccine, influenza, immunogenicity, tolerability, PMED, efficacy, challenge virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
105 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Trivalent DNA vaccine with and without pPJV2012 administered by PMED
Primary Outcome Measure Information:
Title
Efficacy of the vaccine in preventing symptoms of influenza-like illness
Secondary Outcome Measure Information:
Title
Safety and tolerability - AEs and laboratory tests. 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Mant, BSc, FRCP, FFPM
Organizational Affiliation
GDRU
Official's Role
Principal Investigator
Facility Information:
Facility Name
GDRU Quintiles Ltd
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of the Ability of a Flu Vaccine to Prevent Flu Infection
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