RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF).
- Who it may be relevant to
- Registry conditions: CAR-T Cell Therapy, RSV Immunization, Bone Marrow Transplant - Autologous or Allogeneic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Seroconversion Following RSV Vaccination in Bone Marrow Transplant and CAR-T Patients
Overview
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. 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.
Interventions
- Biological 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.
Primary outcome measures
- Fold Rise in Antibody Titers and Seroconversion [Time frame: From the time the patient receives the vaccine to four weeks post-vaccination.]
Secondary outcome measures (2)
- Persistence of Humoral Immune Response [Time frame: From four weeks post-vaccination to six months post-vaccination]
- COVID-19 and Influenza Immunity [Time frame: From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV.]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- 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
- History of a severe allergic reaction to any component of the RSV vaccine
- Use of intravenous immunoglobulin (IVIG) for hypogammaglobulinemia within the past six months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Cooper University Hospital — Camden
Identifiers
NCT: NCT07296120 · 25-114