Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu - Full Text View

Sponsored by:	PowderMed
Information provided by:	PowderMed
ClinicalTrials.gov Identifier:	NCT00347529

Purpose

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

Condition	Intervention	Phase
Influenza (Pandemic)	Biological: pPML7789 with and without pPJV2012 administered by PMED	Phase I

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Randomised Double Blind Dose-Ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine (A Vietnam/1194/2004) Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults

Further study details as provided by PowderMed:

Primary Outcome Measures:

Safety, tolerability and local reactogenicity-AEs and laboratory parameters.

Secondary Outcome Measures:

Immunogenicity of the vaccine

Estimated Enrollment:	75
Study Start Date:	August 2006
Estimated Study Completion Date:	January 2007

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

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Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347529

Locations

United Kingdom
Guys Research Drug Unit, Quintiles Ltd.
London, United Kingdom, SE1 1YR

Sponsors and Collaborators

PowderMed

Investigators

Principal Investigator:

Tim Mant, BSc, FRCP, FFPM

Guys Research Drug Unit, Quintiles UK Ltd.

More Information

Study ID Numbers:	PM FLP-001
Study First Received:	June 30, 2006
Last Updated:	January 25, 2007
ClinicalTrials.gov Identifier:	NCT00347529
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by PowderMed:

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

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009