A Prospective, Randomised, Double Blind, Placebo-Controlled Study to Assess the Efficacy of a Trivalent (A/New Caledonia/20/99, A/Panama/2007/99, B/Jiangsu/10/20) DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) Against a Controlled Influenza Virus Challenge.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- PowderMed
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Efficacy of the vaccine in preventing symptoms of influenza-like illness
- Status
- Completed
- Last Updated
- 19 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Efficacy of the vaccine in preventing symptoms of influenza-like illness
Secondary Outcomes
- Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine