Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-30 @ 9:20 PM
Study NCT ID:
NCT01941758
Status:
COMPLETED
Last Update Posted:
2018-07-05
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical factors such as treatment, disease status, and use of glucocorticoids', 'timeFrame': 'Up to 3 months', 'description': 'Logistic regression models adjusting for age and gender will be used to assess the relationship between seroconversion and clinical factors.'}, {'measure': 'Serologic markers of immune function', 'timeFrame': 'Up to 3 months', 'description': "To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used."}, {'measure': 'Response to vaccination', 'timeFrame': 'Up to 3 months', 'description': "To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used."}], 'primaryOutcomes': [{'measure': 'Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies', 'timeFrame': 'Baseline'}, {'measure': 'Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies', 'timeFrame': 'Day 28'}], 'secondaryOutcomes': [{'measure': 'GMT', 'timeFrame': 'Up to 3 months', 'description': 'Continuous values will be analyzed using Wilcoxon rank sum tests to compare high dose influenza vaccine to previously reported data on immunogenicity to the standard trivalent inactivated vaccine.'}, {'measure': 'Seroconversion', 'timeFrame': 'Up to 3 months', 'description': 'Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.'}, {'measure': 'Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40', 'timeFrame': 'Up to 3 months', 'description': 'Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Nervous System Neoplasm']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors. Studying samples of blood in the laboratory from patients receiving trivalent influenza vaccine may help doctors learn more about the effects of trivalent influenza vaccine on cells. It may also help doctors understand how well patients respond to treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To estimate the immunogenicity of high-dose influenza vaccination in patients with central nervous system tumors.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the geometric mean titer (GMT) in patients after administration of high-dose influenza vaccination compared to previously determined geometric mean titer (GMT) among 38 patients receiving the standard yearly influenza vaccination.\n\nII. To assess the seroconversion rates (i.e. four-fold rise in titer) compared to previously determined seroconversion following administration of the standard yearly influenza vaccination.\n\nIII. To assess the seroprotection rates (i.e. post-vaccination titer \\>= 1:40) compared to previously determined seroconversion and seroprotection following administration of the standard yearly influenza vaccination.\n\nTERTIARY OBJECTIVES:\n\nI. To assess the relationship between serologic markers of immune function and response to high-dose vaccination.\n\nOUTLINE:\n\nPatients receive trivalent influenza vaccine on day 1.\n\nAfter completion of study, patients are followed up at 28 days and/or 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a clinical diagnosis of a primary central nervous system tumor\n* Patients must be eligible to receive the influenza vaccine\n* Patients must be willing to receive the Fluzone® high-dose seasonal influenza vaccine\n* Patients must be willing and able to sign an Institutional Review Board (IRB)-approved written informed consent document\n\nExclusion Criteria:\n\n* Patients unable to receive the high-dose influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillain-Barré syndrome, or other contraindication to the vaccine\n* Patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study'}, 'identificationModule': {'nctId': 'NCT01941758', 'briefTitle': 'High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors', 'orgStudyIdInfo': {'id': 'IRB00024870'}, 'secondaryIdInfos': [{'id': 'NCI-2013-01740', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CCCWFU 97413', 'type': 'OTHER', 'domain': 'Comprehensive Cancer Center of Wake Forest University'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basic science (trivalent influenza vaccine)', 'description': 'Patients receive trivalent influenza vaccine on day 1.', 'interventionNames': ['Biological: trivalent influenza vaccine', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'trivalent influenza vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Flushield', 'Fluvirin', 'Fluzone', 'Influenza Vaccine'], 'armGroupLabels': ['Basic science (trivalent influenza vaccine)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Basic science (trivalent influenza vaccine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Glenn Lesser', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}