A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by:
PowderMed
ClinicalTrials.gov Identifier:
NCT00375206
First received: September 11, 2006
Last updated: January 25, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by PowderMed:

Primary Outcome Measures:
  • Safety, tolerability and local reactogenicity - AEs and laboratory parameters

Secondary Outcome Measures:
  • Immunogenicity of the vaccine

Estimated Enrollment: 189
Study Start Date: September 2006
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375206

Locations
United States, Kansas
Quintiles Lenexa (QLX)
Lenexa, Kansas, United States, 66219
United States, Missouri
Biokinetic
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
PowderMed
Investigators
Principal Investigator: Philip Leese, MD Quintiles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375206     History of Changes
Other Study ID Numbers: PM FLS-001
Study First Received: September 11, 2006
Last Updated: January 25, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by PowderMed:
PowderMed, DNA vaccine, influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014