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OpenTrials
Completed

NCT Number: NCT00375206

A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

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.

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Key information

Conditions

Influenza 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

Quintiles Lenexa (QLX), Lenexa, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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

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

Important dates

Study start
2006
Study completion
2007
First posted
Sep 12, 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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