Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
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
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
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