A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring PowderMed, DNA vaccine, influenza
Eligibility Criteria
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
Sites / Locations
- Quintiles Lenexa (QLX)
- Biokinetic
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
NCT00375206
Brief Title
A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
Official Title
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
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
PowderMed, DNA vaccine, influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
189 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Leese, MD
Organizational Affiliation
Quintiles, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quintiles Lenexa (QLX)
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Biokinetic
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
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