A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

PowderMed

Status and phase: Completed; Phase 1

Conditions: Influenza

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00375206

PM FLS-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind