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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Influenza

Keywords

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DNA vaccine influenza immunogenicity tolerability PMED efficacy challenge virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Trivalent DNA vaccine with and without pPJV2012 administered by PMED

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Tim Mant, BSc, FRCP, FFPM

Role: PRINCIPAL_INVESTIGATOR

GDRU

Locations

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GDRU Quintiles Ltd

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PM FLS-002

Identifier Type: -

Identifier Source: org_study_id