Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT00769002
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2008-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PET-CT Scans in Healthy Volunteers After Flu Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DSchwartz@hackensackumc.org', 'phone': '551-996-2000', 'title': 'Dr. David Schwartz', 'organization': 'Hackensack University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study was not completed and data collected is not available despite all efforts as PI has left the institution. No manuscript/study report was developed and there are no data to confirm validity or address comments in previously entered results'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Influenza Vaccine FluShield, FluMist', 'description': 'Previous influenza positivity\n\nPrimary Outcome Measure:\n\n1. PET-CT Scan \\[Time Frame: 4-7 days after flu vaccine\\]\n\n Secondary Outcome Measures:\n2. Cytokine Profiling \\[Time Frame: 2-6 weeks and 10-12 months post flu vaccination\n\nFluShield, FluMist: Flu vaccine', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cytokine Profiling FluShield, FluMist', 'description': 'No previous influenza positivity\n\nPrimary Outcome Measure:\n\n1. PET-CT Scan \\[Time Frame: 4-7 days after flu vaccine\\]\n\n Secondary Outcome Measures:\n2. Cytokine Profiling \\[Time Frame: 2-6 weeks and 10-12 months post flu vaccination\n\nFluShield, FluMist: Flu vaccine', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PET Scan AB Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PET-CT Scan Influenza Vaccine Response', 'description': 'Previous influenza positivity\n\nFluShield, FluMist: Flu vaccine\n\nPrevious influenza positivity\n\nPrimary Outcome Measure:\n\n1. Not Posted PET-CT Scan \\[Time Frame: 4-7 days after flu vaccine\\]\n\n Secondary Outcome Measures:\n2. Not Posted Cytokine Profiling \\[Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity\n\nPrimary Outcome Measure:\n\n1. Not Posted PET-CT Scan \\[Time Frame: 4-7 days after flu vaccine\\]\n\n Secondary Outcome Measures:\n2. Not Posted Cytokine Profiling \\[Time Frame: 2-6 weeks and 10-12 months post flu vaccination'}], 'timeFrame': '4-7 days', 'description': 'Natural infection but not ipsilateral IM injection of FluShield, will prime the host for a specific activation of spleen and bilateral lymph nodes following a subsequent i.m injection of FluShield, as detected by PET-CT performed 4-7 days post- FluShield immunization.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was not completed as planned, and data collected is not available despite all efforts as the PI has left the institution. Additionally, no manuscript, or study report was developed and therefore no data available to confirm the validity of or address the comments in relation to the previously entered results information.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PET-CT Scan Influenza Vaccine Response', 'description': 'Previous influenza positivity\n\nFluShield, FluMist: Flu vaccine\n\nPrevious influenza positivity\n\nPrimary Outcome Measure:\n\n1. Not Posted PET-CT Scan \\[Time Frame: 4-7 days after flu vaccine\\]\n\n Secondary Outcome Measures:\n2. Not Posted Cytokine Profiling \\[Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity\n\nPrimary Outcome Measure:\n\n1. Not Posted PET-CT Scan \\[Time Frame: 4-7 days after flu vaccine\\]\n\n Secondary Outcome Measures:\n2. Not Posted Cytokine Profiling \\[Time Frame: 2-6 weeks and 10-12 months post flu vaccination'}, {'id': 'FG001', 'title': 'Cytokine Profiling', 'description': 'No previous influenza positivity\n\nFluShield, FluMist: Flu vaccine\n\nPrimary Outcome Measure:\n\n1. Not Posted PET-CT Scan \\[Time Frame: 4-7 days after flu vaccine\\]\n\n Secondary Outcome Measures:\n2. Not Posted Cytokine Profiling \\[Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity\n\nPrimary Outcome Measure:\n\n1. Not Posted PET-CT Scan \\[Time Frame: 4-7 days after flu vaccine\\]\n\n Secondary Outcome Measures:\n2. Not Posted Cytokine Profiling \\[Time Frame: 2-6 weeks and 10-12 months post flu vaccination'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Study was not completed, no data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Influenza Vaccine FluShield, FluMist', 'description': 'Group I - Previous influenza positivity A or B within the past 5 years'}, {'id': 'BG001', 'title': 'Cytokine Profiling FluShield, FluMist', 'description': 'Group II - History of FluMist vaccination within the past 2 years'}, {'id': 'BG002', 'title': 'Unilateral TIV Injections FluShield', 'description': 'Group III a - History of TIV vaccination, any number of times, but only in a single (e.g., non-dominant) arm. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa).'}, {'id': 'BG003', 'title': 'Opposite Arm FluShield', 'description': 'Group IIIb - Within one month of screening and baseline blood draws for PBMCs and Ab titers, individuals will receive FluShield injections. The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}], 'description': 'Men and women ages 21-55'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}], 'populationDescription': 'This study was not completed as planned, and data collected is not available despite all efforts as the PI has left the institution. Additionally, no manuscript, or study report was developed and therefore no data available to confirm the validity of or address the comments in relation to the previously entered results information.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2008-10-07', 'resultsFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-16', 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PET Scan AB Response', 'timeFrame': '4-7 days', 'description': 'Natural infection but not ipsilateral IM injection of FluShield, will prime the host for a specific activation of spleen and bilateral lymph nodes following a subsequent i.m injection of FluShield, as detected by PET-CT performed 4-7 days post- FluShield immunization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['influenza', 'flu', 'vaccine', 'vaccination', 'immune response', 'FluShield', 'FluMist', 'PET-CT', 'Healthy Volunteers'], 'conditions': ['Flu']}, 'descriptionModule': {'briefSummary': 'This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination.', 'detailedDescription': 'Until recently, all recipients of influenza vaccine received a killed form of virus, typically in the same nondominant arm, each year before flu season. We hypothesize that natural infection, and some forms of vaccination, could allow vaccine induced responses to spread beyond the local lymph nodes near the vaccination site. From a practical perspective, if vaccine induced proliferation of specific immune cells in sites distant from the vaccination site lead to beneficial immune memory, it would suggest vaccination strategies that could be as simple as alternating the injected arm from year to year, or alternating inhaled vs. injected forms of vaccine.\n\nThis will be a 4 armed prospective study of individuals receiving unilateral FluShield i.m. Healthy adult volunteers 21-55 will be grouped according to the following criteria: I. Documented history of prior natural infection with influenza A or B within the past 5 years (diagnostic test or high titer hemagglutinin HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV (Trivalent (Inactivated) Influenza Vaccine) vaccination, any number of times, but only in a single (e.g., non-dominant) arm. Within one month of screening and baseline blood draws for PBMCs (Peripheral blood mononuclear cells) and Ab (antibody) titers, individuals will receive FluShield injections. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).\n\nUpon entering the study, 50cc of heparinized blood and 10 cc of serum will be drawn by antecubital venipuncture. Within 4 weeks of this blood draw, volunteers will receive a standard dose of i.m. TIV (FluShield). Four-seven days later they will have an FDG PET-CT scan performed after an 8 hour fast.\n\nAdditional blood draws of 50cc heparinized blood and 10 cc serum will be obtained at 2, 4, and 6 weeks post vaccination, and at 10-12 months post vaccination. After the last blood draw, volunteers will also be asked questions pertaining to flu-like symptoms during the past 10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 21-55 years old.\n* Willingness to participate in the study for a full year including multiple blood draws and PET-CT scanning\n\nExclusion Criteria:\n\n* Diabetes\n* Use of systemic steroids\n* Pregnancy or unwillingness to practice birth control of some kind through the PET-CT scanning period\n* Recent vaccination for other reasons (e.g., traveler\'s vaccines)\n* Significant intercurrent illness that might interfere with vaccination "take" or interpretation of PET-CT scanning (e.g., chemotherapy for cancer)'}, 'identificationModule': {'nctId': 'NCT00769002', 'acronym': 'Pro00000226', 'briefTitle': 'PET-CT Scans in Healthy Volunteers After Flu Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'Impact of Bilateral Priming on Response to Unilateral Flu Vaccination', 'orgStudyIdInfo': {'id': 'Pro00000226 - R21AI077102'}, 'secondaryIdInfos': [{'id': '5R21AI077102-03', 'link': 'https://reporter.nih.gov/quickSearch/5R21AI077102-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Natural Infection', 'description': 'previously naturally infected', 'interventionNames': ['Biological: FluShield', 'Procedure: Blood Draws', 'Procedure: FDG PET-CT Scan', 'Genetic: Cytokine Profiling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FluShield - influenza positivity', 'description': 'prior FluShield ipsilateral vaccinated', 'interventionNames': ['Biological: FluShield', 'Biological: FluShield - same arm', 'Procedure: Blood Draws', 'Procedure: FDG PET-CT Scan', 'Genetic: Cytokine Profiling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FluShield - influenza positivity2', 'description': 'prior FluShield contralateral vaccinated', 'interventionNames': ['Biological: FluShield', 'Biological: FluShield - opposite arm', 'Procedure: Blood Draws', 'Procedure: FDG PET-CT Scan', 'Genetic: Cytokine Profiling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FluMist', 'description': 'prior FluMist vaccinated.', 'interventionNames': ['Biological: FluShield', 'Procedure: Blood Draws', 'Procedure: FDG PET-CT Scan', 'Genetic: Cytokine Profiling']}], 'interventions': [{'name': 'FluShield', 'type': 'BIOLOGICAL', 'description': 'Flu vaccine', 'armGroupLabels': ['FluMist', 'FluShield - influenza positivity', 'FluShield - influenza positivity2', 'Natural Infection']}, {'name': 'FluShield - same arm', 'type': 'BIOLOGICAL', 'description': 'Flu vaccine', 'armGroupLabels': ['FluShield - influenza positivity']}, {'name': 'FluShield - opposite arm', 'type': 'BIOLOGICAL', 'description': 'Flu vaccine', 'armGroupLabels': ['FluShield - influenza positivity2']}, {'name': 'Blood Draws', 'type': 'PROCEDURE', 'description': '50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination', 'armGroupLabels': ['FluMist', 'FluShield - influenza positivity', 'FluShield - influenza positivity2', 'Natural Infection']}, {'name': 'FDG PET-CT Scan', 'type': 'PROCEDURE', 'description': 'PET scan', 'armGroupLabels': ['FluMist', 'FluShield - influenza positivity', 'FluShield - influenza positivity2', 'Natural Infection']}, {'name': 'Cytokine Profiling', 'type': 'GENETIC', 'description': 'Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination', 'armGroupLabels': ['FluMist', 'FluShield - influenza positivity', 'FluShield - influenza positivity2', 'Natural Infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack Univarsity medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'overallOfficials': [{'name': 'David Schwartz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}