A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00375206

Enrollment

189

Registered

2006-09-12

Start date

2006-09-30

Completion date

2007-01-31

Last updated

2007-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

PowderMed, DNA vaccine, influenza

Brief 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.

Detailed 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.

Interventions

BIOLOGICALTrivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Safety, tolerability and local reactogenicity - AEs and laboratory parameters	—

Secondary

Measure	Time frame
Immunogenicity of the vaccine	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026