Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-25 @ 4:58 PM
Study NCT ID:
NCT00375206
Status:
COMPLETED
Last Update Posted:
2007-01-29
First Post:
2006-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2007-01-25', 'studyFirstSubmitDate': '2006-09-11', 'studyFirstSubmitQcDate': '2006-09-11', 'lastUpdatePostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, tolerability and local reactogenicity - AEs and laboratory parameters'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity of the vaccine'}]}, 'conditionsModule': {'keywords': ['PowderMed, DNA vaccine, influenza'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Ages Eligible for Study:\n\n* 18 Years - 50 Years\n* Genders Eligible for Study: Both\n* Accepts Healthy Volunteers\n\nCriteria\n\nInclusion Criteria:\n\n* Healthy adult volunteers (women must be of non child-bearing potential)\n* Provided written informed consent\n\nExclusion Criteria:\n\n* No significant concomitant illness\n* No allergy to gold\n* No immunosuppression due to disease or treatment\n* No previous flu vaccination in 2005 or 2006'}, 'identificationModule': {'nctId': 'NCT00375206', 'briefTitle': 'A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'PowderMed'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PM FLS-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Quintiles Lenexa (QLX)', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Biokinetic', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], 'overallOfficials': [{'name': 'Philip Leese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PowderMed', 'class': 'INDUSTRY'}}}}