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OpenTrials
Completed

NCT Number: NCT00347529

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

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

Completed

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Key information

Conditions

Influenza (Pandemic) Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guys Research Drug Unit, Quintiles Ltd.

London, SE1 1YR, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pPML7789 with and without pPJV2012 administered by PMED

Biological

Primary outcomes

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

Secondary outcomes

  1. Immunogenicity of the vaccine

Sponsors and collaborators

Lead sponsor

PowderMed

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Jul 4, 2006
Registry last updated
Jan 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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