Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 1:39 PM
Study NCT ID:
NCT06567860
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2024-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterizing Late-season Influenza Vaccine Responses to Compare the 2023 and 2024 Vaccine Formulations
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of antibody response post-vaccination', 'timeFrame': '0, 30, and 90 days post-vaccination', 'description': 'The antibody response will be measured by hemagglutination inhibition (HAI) in adults between 18 and 64 years old who have not had an influenza vaccination prior to the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza vaccine', 'Immune response'], 'conditions': ['Influenza A']}, 'descriptionModule': {'briefSummary': 'Every 1-2 years, the seasonal influenza vaccine composition changes to include updated viruses, yet the precise effects of updating the vaccine remain understudied. Since the vaccine formulation for each season (with a season defined as starting in July and ending the following June) expires on June 30, vaccine formulations cannot be compared head-to-head. Thus, the 2023 and 2024 vaccines have only been compared by analyzing people given the former vaccine in the fall of 2023 and people given the latter vaccine in the fall of 2024, and baseline repertoires may have greatly changed over the course of that year. To that end, the investigators will vaccinate a cohort with the 2023 influenza vaccine between May-June 2024, in order to compare responses between individuals receiving the 2023 vaccine last fall, the 2023 vaccine late in the season (this cohort), and the 2024 vaccine next fall. The investigators will further assess whether the late-season 2023 vaccine primed this cohort to respond better to the standard 2024 vaccine with standard timing (vaccine administered around September-October).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 18-64 years of age\n* Males or non-pregnant, non-nursing females\n* Weigh at least 85 pounds for whole blood draw\n* Ability to provide signed informed consent\n* Subjects must plan to receive the intramuscular influenza vaccine at the La Jolla Institute for Immunology\n\nExclusion Criteria:\n\n* Received an influenza vaccine in the past year\n* Infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus\n* History of certain anemias\n* Presence of significant cardiovascular disease, systemic diseases including, but not limited to, diabetes which is not controlled, renal disease, liver disease, malignancy, infection, or blood clotting disorder\n* Inability to provide informed consent\n* Recent whole blood donation within 56 days or leukapheresis within 112 days\n* Children (under 18 years of age), elderly (65 years of age or older), pregnant or nursing females\n* Individuals with egg allergies\n* Has ever had Guillain-Barré syndrome'}, 'identificationModule': {'nctId': 'NCT06567860', 'briefTitle': 'Characterizing Late-season Influenza Vaccine Responses to Compare the 2023 and 2024 Vaccine Formulations', 'organization': {'class': 'OTHER', 'fullName': 'La Jolla Institute for Immunology'}, 'officialTitle': 'Characterizing Late-season Influenza Vaccine Responses to Compare the 2023 and 2024 Vaccine Formulations', 'orgStudyIdInfo': {'id': '286'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Late season influenza vaccine', 'description': 'Every participant receives the 2023 influenza vaccine between May-June 2024, and then the 2024 influenza vaccine in September-October 2024. Blood draws are taken at Day 0, 30, and 90 post-vaccination.', 'interventionNames': ['Biological: Influenza Fluzone vaccine']}], 'interventions': [{'name': 'Influenza Fluzone vaccine', 'type': 'BIOLOGICAL', 'description': 'Fluzone vaccine administered in both May-June and in September-October for each participant.', 'armGroupLabels': ['Late season influenza vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'La Jolla Institute for Immunology', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Tal Einav, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Jolla Institute for Immunology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'Data will be available upon publication.', 'ipdSharing': 'YES', 'description': 'De-identified data will be included in all relevant publications.', 'accessCriteria': 'Data will be available with no restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'La Jolla Institute for Immunology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Tal Einav', 'investigatorAffiliation': 'La Jolla Institute for Immunology'}}}}