Status and phase
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About
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
Full 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
Sex
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Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
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Data sourced from clinicaltrials.gov
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