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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza (Pandemic)
• Intervention / Treatment: Biological: pPML7789 with and without pPJV2012 administered by PMED

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

• Study Type: Interventional
• Enrollment: 75
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Immunogenicity of the vaccine

Collaborators and Investigators

• Sponsor: PowderMed
• Investigators: Principal Investigator: Tim Mant, BSc, FRCP, FFPM, Guys Research Drug Unit, Quintiles UK Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Study Completion: January 1, 2007

Study Registration Dates

• First Submitted: June 30, 2006
• First Submitted That Met QC Criteria: June 30, 2006
• First Posted (Estimate): July 4, 2006

Study Record Updates

• Last Update Posted (Estimate): January 29, 2007
• Last Update Submitted That Met QC Criteria: January 25, 2007
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Keywords: DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: PM FLP-001