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NCT00375206 Clinical Trial

A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

Influenza Clinical Trial

Official title:
A Phase I Study to Assess Safety, Tolerability and Immunogenicity of a Trivalent Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00375206
Other study ID # PM FLS-001
Secondary ID
Status Completed
Phase Phase 1
First received September 11, 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 States: Food and Drug Administration
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 and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune 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 is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.

Recruitment information / eligibility
Status Completed
Enrollment 189
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Ages Eligible for Study:

- 18 Years - 50 Years

- Genders Eligible for Study: Both

- Accepts Healthy Volunteers

Criteria

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

- No previous flu vaccination in 2005 or 2006

Study Design

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

Related Conditions & MeSH terms

Intervention

Biological:
• Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)

Locations
Country Name City State
United States Quintiles Lenexa (QLX) Lenexa Kansas
United States Biokinetic Springfield Missouri

Sponsors (1)
Lead Sponsor Collaborator
PowderMed

Country where clinical trial is conducted

United States, 

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