A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

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

189 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 well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune 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 is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.

Conditions

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Influenza

Keywords

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PowderMed, DNA vaccine, influenza

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 (PIA0601) with or without DEI-LT (pPJV2012)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 18 Years - 50 Years
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers

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
* No previous flu vaccination in 2005 or 2006

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Philip Leese, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Quintiles Lenexa (QLX)

Lenexa, Kansas, United States

Site Status

Biokinetic

Springfield, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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PM FLS-001

Identifier Type: -

Identifier Source: org_study_id