Study of the Ability of a Flu Vaccine to Prevent Flu Infection

Influenza Clinical Trial

Official title:

A Prospective, Randomised, Double Blind, Placebo-Controlled Study to Assess the Efficacy of a Trivalent (A/New Caledonia/20/99, A/Panama/2007/99, B/Jiangsu/10/20) DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) Against a Controlled Influenza Virus Challenge.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349037
• Other study ID #: PM FLS-002
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2006
• Last updated: January 25, 2007
• Start date: September 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 effective the vaccine is at preventing subjects developing flu symptoms after they are directly exposed to flu virus. The study will also 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

Description:

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 will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for influenza as a potential alternative to existing vaccine technologies. This study will assess how effective two different PMED vaccine combinations are at preventing subjects developing influenza following exposure to flu virus 56 days after a single dose of vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion 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

Pre-existing protective level of antibody against the challenge virus strain

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Trivalent DNA vaccine with and without pPJV2012 administered by PMED

Locations

Country	Name	City	State
United Kingdom	GDRU 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	Efficacy of the vaccine in preventing symptoms of influenza-like illness
Secondary	Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine