RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients
NCT ID: NCT07296120
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2026-01-01
2027-06-30
Brief Summary
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The 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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Vaccine Recipients
Patients who will recieve the RSV vaccine
Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)
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.
Interventions
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Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of hematological malignancy
* Treatment with HSCT or CAR-T therapy
* Must be able to give informed consent
* Must be willing to provide blood samples after HSCT or CAR-T therapy and prior to vaccination
* Must be willing to provide blood samples at four weeks and six months post-vaccination
* Must have an insurance plan that covers the cost of recieving the RSV vaccine.
Exclusion Criteria
* Use of intravenous immunoglobulin (IVIG) for hypogammaglobulinemia within the past six months
18 Years
ALL
No
Sponsors
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The Cooper Foundation
UNKNOWN
The Cooper Health System
OTHER
Responsible Party
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Anil Rengan
Assistant Professor of Medicine, Hematology/Oncology, Cooper University Health Care
Locations
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Cooper University Hospital
Camden, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Anil K Rengan, MD
Role: primary
Other Identifiers
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25-114
Identifier Type: -
Identifier Source: org_study_id