Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-01-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Influenza (Pandemic)

Keywords

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DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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pPML7789 with and without pPJV2012 administered by PMED

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent

\-

Exclusion Criteria

No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment

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

Guys Research Drug Unit, Quintiles UK Ltd.

Locations

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Guys Research Drug Unit, Quintiles Ltd.

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PM FLP-001

Identifier Type: -

Identifier Source: org_study_id