Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT07296120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fold Rise in Antibody Titers and Seroconversion', 'timeFrame': 'From the time the patient receives the vaccine to four weeks post-vaccination.', 'description': 'The primary endpoint is the fold rise in antibody titers against the preF protein at four weeks post-vaccination compared to pre-vaccination (baseline) levels. An additional related objective is to assess whether patients are able to achieve seroconversion. The endpoint for this objective is the proportion of patients with at least a four-fold increase in neutralizing titers from the pre-vaccination baseline at four weeks post-vaccination.'}], 'secondaryOutcomes': [{'measure': 'Persistence of Humoral Immune Response', 'timeFrame': 'From four weeks post-vaccination to six months post-vaccination', 'description': 'The secondary objective is to assess whether patients who achieve seroconversion at four weeks post-vaccination retain high levels of neutralizing antibodies at six months post-vaccination. The endpoint for this objective is the fold change in antibody titers against the preF protein at six months post-vaccination compared to four weeks post-vaccination.'}, {'measure': 'COVID-19 and Influenza Immunity', 'timeFrame': 'From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV.', 'description': 'Although vaccination against these pathogens is not part of the study protocol, neutralizing antibody titers for influenza and COVID-19 will be obtained alongside RSV titers as part of a broader titer analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CAR-T Cell Therapy', 'RSV Immunization', 'Bone Marrow Transplant - Autologous or Allogeneic']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether the RSV vaccine Abrysvo can produce an antibody response in patients with blood cancers who have previously received a hematopoietic stem cell transplant (HSCT) or CAR-T cell therapy. The vaccine targets the prefusion F (preF) protein of RSV, which is an important component of protective immunity against the virus.\n\nThe main goal of the study is to measure the change in antibody levels against the preF protein four weeks after vaccination compared with levels before vaccination. The study will also assess whether participants develop a meaningful immune response, defined as at least a four-fold increase in RSV neutralizing antibody levels four weeks after vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of hematological malignancy\n* Treatment with HSCT or CAR-T therapy\n* Must be able to give informed consent\n* Must be willing to provide blood samples after HSCT or CAR-T therapy and prior to vaccination\n* Must be willing to provide blood samples at four weeks and six months post-vaccination\n* Must have an insurance plan that covers the cost of recieving the RSV vaccine.\n\nExclusion Criteria:\n\n* History of a severe allergic reaction to any component of the RSV vaccine\n* Use of intravenous immunoglobulin (IVIG) for hypogammaglobulinemia within the past six months'}, 'identificationModule': {'nctId': 'NCT07296120', 'briefTitle': 'RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients', 'organization': {'class': 'OTHER', 'fullName': 'The Cooper Health System'}, 'officialTitle': 'Seroconversion Following RSV Vaccination in Bone Marrow Transplant and CAR-T Patients', 'orgStudyIdInfo': {'id': '25-114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine Recipients', 'description': 'Patients who will recieve the RSV vaccine', 'interventionNames': ['Biological: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)']}], 'interventions': [{'name': 'Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)', 'type': 'BIOLOGICAL', 'description': 'Patients will receive a single dose of the Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) starting at three months post-HSCT or CAR-T therapy.', 'armGroupLabels': ['Vaccine Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'contacts': [{'name': 'Anil K Rengan, MD', 'role': 'CONTACT', 'email': 'rengan-anil@cooperhealth.edu', 'phone': '855-632-2667'}], 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}], 'centralContacts': [{'name': 'Anil K Rengan, MD', 'role': 'CONTACT', 'email': 'rengan-anil@cooperhealth.edu', 'phone': '855-632-2667'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cooper Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cooper Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, Hematology/Oncology, Cooper University Health Care', 'investigatorFullName': 'Anil Rengan', 'investigatorAffiliation': 'Cooper University Health Care'}}}}