Influenza (Pandemic)
Conditions
Keywords
DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
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
Interventions
BIOLOGICALpPML7789 with and without pPJV2012 administered by PMED
Sponsors
PowderMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, tolerability and local reactogenicity-AEs and laboratory parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity of the vaccine | — |
Countries
United Kingdom
Outcome results
None listed