Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-01 @ 10:12 AM
Study NCT ID:
NCT04531657
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influenza Vaccine in Lung Transplant Patients - Seroprotection
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'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Seroprotection to Influenza Vaccine: 40 HAU', 'timeFrame': 'up to 6 months', 'description': 'The hypothesis is that seroprotection, defined as 40 HAU or greater, will persist up to 6 months at high rates in lung transplant patients and that these rates will be comparable to the rates in healthy individuals. Seroprotection (antibody titer greater than or equal to 1:40) will be reported for H1N1, H3N2, and B viral antigens.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Seroprotection to Influenza Vaccine: 160 HAU', 'timeFrame': 'up to 6 months', 'description': 'Seroprotection (antibody titer greater than or equal to 1:160) will be reported for H1N1, H3N2, and B viral antigens.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-lung transplant', 'Healthy'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '25148380', 'type': 'RESULT', 'citation': 'Long AJ, Worzella SL, Moran JJ, Hayney MS. Influenza vaccine antibody response and 6-month persistence in lung transplant recipients using two definitions of seroprotection. Transplantation. 2015 Apr;99(4):885-9. doi: 10.1097/TP.0000000000000391.'}]}, 'descriptionModule': {'briefSummary': 'This a sub-study of a 5-year study designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.\n\nThis study is designed to investigate two different definitions of influenza vaccine seroprotection at mid-season in lung transplant patients.', 'detailedDescription': 'Given the significant risk of morbidity and mortality, it is critical and highly recommended that lung transplant patients receive annual influenza immunizations that confer protection throughout the influenza season. Previous studies have demonstrated that transplant recipients and nonimmunocompromised populations display similar rates of seroprotection between 3 and 5 weeks after influenza vaccination, despite the transplant population achieving generally lower antibody concentrations. Two studies show influenza vaccine antibody persistence at reasonable rates at 1 year, but not 2 years, after immunization. However, there are no studies comparing seroprotection rates 6 months after vaccination, reflecting adequate coverage throughout the entire influenza season.\n\nSeroprotection has traditionally been defined as an antibody concentration of at least 40 hemagglutination units (HAU) after vaccination, which is the criterion for influenza vaccine licensure. This concentration of antibody provides protection from infection at a rate of about 50% in typically healthy individuals. Protection from infection improves with higher antibody concentrations. For this study, a HAU of at least 160 was selected as a more conservative definition of seroprotection, where protection may reach up to 95%.\n\nThe hypothesis is that seroprotection, defined as 40 HAU or greater, will persist up to 6 months at high rates in lung transplant patients and that these rates will be comparable to the rates in healthy individuals. As a secondary outcome, seroprotection rates are compared when 160 HAU or greater was used to define seroprotection.\n\nInfluenza vaccine responses in lung transplant patients and healthy control subjects without lung disease will be compared over the course of the 2008 to 2009 influenza season.\n\nSerum collected from participants before immunization, 2 to 4 weeks after immunization (postimmunization), and 6 months after immunization.\n\n\\[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult or patient receiving care post-lung transplant at University of Wisconsin Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Receiving care post-lung transplant at University of Wisconsin Hospital\n* Healthy adult\n\nExclusion Criteria:\n\n* Allergy to eggs\n* Moderate to severe febrile illness\n* Active treatment for acute rejection\n* Received season's influenza vaccine prior to enrollment"}, 'identificationModule': {'nctId': 'NCT04531657', 'briefTitle': 'Influenza Vaccine in Lung Transplant Patients - Seroprotection', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Influenza Vaccine Antibody Response and 6-month Persistence in Lung Transplant Recipients Using Two Definitions of Seroprotection', 'orgStudyIdInfo': {'id': 'H-2004-0240e'}, 'secondaryIdInfos': [{'id': 'A561000', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'PHARM/PHARMACY/PHARMACY', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '2009-0002', 'type': 'REGISTRY', 'domain': 'Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccine, Post-transplant', 'description': 'Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.', 'interventionNames': ['Drug: Influenza vaccine']}, {'label': 'Vaccine, Healthy Control', 'description': 'Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually.', 'interventionNames': ['Drug: Influenza vaccine']}], 'interventions': [{'name': 'Influenza vaccine', 'type': 'DRUG', 'description': 'influenza vaccine 0.5 ml intramuscularly during 2008-2009 season for measurement of A/Brisbane/59/2007(H1N1)-like, A/Brisbane/10/2007(H3N2)-like, and B/Florida/4/2006-like antigens', 'armGroupLabels': ['Vaccine, Healthy Control', 'Vaccine, Post-transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Mary S Hayney, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}