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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pPML7789 with and without pPJV2012 administered by PMED | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability and local reactogenicity-AEs and laboratory parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of the vaccine |
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Inclusion Criteria:
Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent
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Exclusion Criteria:
No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment
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| Name | Affiliation | Role |
|---|---|---|
| Tim Mant, BSc, FRCP, FFPM | Guys Research Drug Unit, Quintiles UK Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys Research Drug Unit, Quintiles Ltd. | London | SE1 1YR | United Kingdom |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |