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

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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00349037
Enrollment
105
Registered
2006-07-06
Start date
2006-09-30
Completion date
2007-01-31
Last updated
2007-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

DNA vaccine, influenza, immunogenicity, tolerability, PMED, efficacy, challenge virus

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.

Interventions

BIOLOGICALTrivalent DNA vaccine with and without pPJV2012 administered by PMED

Sponsors

PowderMed
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Efficacy of the vaccine in preventing symptoms of influenza-like illness

Secondary

MeasureTime frame
Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026