Study of the Ability of a Flu Vaccine to Prevent Flu Infection
Study of the Ability of a Flu Vaccine to Prevent Flu Infection
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
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.
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