Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-28 @ 11:25 AM
Study NCT ID:
NCT00755703
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2008-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D005585', 'term': 'Influenza in Birds'}], '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'}, {'id': 'D001715', 'term': 'Bird Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-24', 'studyFirstSubmitDate': '2008-09-17', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.', 'timeFrame': '56 day observations with 2 year follow-up'}], 'secondaryOutcomes': [{'measure': 'Determination of immunogenicity and correlates of protection based on HI titers in vaccinates', 'timeFrame': '28 days and 56 days post vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Influenza', 'Vaccine', 'Pandemic', 'Avian influenza', 'Adenovirus strain 5', 'Vectored vaccine', 'Intranasal', 'Tissue-culture derived', 'Non-replicating'], 'conditions': ['Influenza A Subtype H5N1 Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies.\n\nThe vaccine is non-replicating, tissue culture based and designed for intranasal delivery.', 'detailedDescription': 'Objectives:\n\nThe primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.\n\nThe secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males and females in good general health, 19-49 years of age\n* Subjects must provide written consent\n* Willing to participate through study completion\n* Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis\n* Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.\n* Meet screening criteria for hematology, chemistry and urinalysis\n\nExclusion Criteria:\n\n* Pregnant (or possibly pregnant) and lactating women\n* Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment\n* Any intranasal steroid medication administered in the 10 days prior to study enrollment\n* History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities\n* Any previous nasal cautery or significant surgery for nasal septal defects\n* Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use\n* Asthma that is greater than mild in severity\n* Diagnosed active Hepatitis B or C\n* HIV positive at screening\n* Known or suspected malignancy, leukemia, or lymphoma\n* Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids\n* Receipt of an influenza vaccine within the past 6 months\n* Receipt of any vaccine in the past 30 days\n* Receipt of any investigational drug in the past 30 days\n* Known Diabetes mellitus\n* History of anaphylaxis or angioedema\n* Hypertension that is not well controlled\n* Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent"}, 'identificationModule': {'nctId': 'NCT00755703', 'briefTitle': 'Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Altimmune, Inc.'}, 'officialTitle': 'A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults', 'orgStudyIdInfo': {'id': 'H-0701-2'}, 'secondaryIdInfos': [{'id': '#1-UCI-AI-06205-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'There will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).', 'interventionNames': ['Biological: Pandemic Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'There will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).', 'interventionNames': ['Biological: Pandemic Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'There will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d).', 'interventionNames': ['Biological: Pandemic Influenza Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Experimental: Group 4', 'description': 'There will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d).', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Pandemic Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'Undetermined', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Experimental: Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-2050', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Vaccine Research Center (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Scott D. Parker, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alabama Vaccine Research Clinic, University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altimmune, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}