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

Influenza (Pandemic) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347529
• Other study ID #: PM FLP-001
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2006
• Last updated: January 25, 2007
• Start date: August 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: PowderMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza (Pandemic)
• Influenza, Human

Intervention

Biological:
• pPML7789 with and without pPJV2012 administered by PMED

Locations

Country	Name	City	State
United Kingdom	Guys Research Drug Unit, Quintiles Ltd.	London

Sponsors (1)

Lead Sponsor	Collaborator
PowderMed

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability and local reactogenicity-AEs and laboratory parameters.
Secondary	Immunogenicity of the vaccine