RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients

NCT07296120 — Phase 4, Not yet recruiting, 30 participants, The Cooper Health System

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Seroconversion Following RSV Vaccination in Bone Marrow Transplant and CAR-T Patients

Registry	NCT07296120
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	30 (Estimated)
Sponsor	The Cooper Health System (Other); collaborators: The Cooper Foundation
Conditions	CAR-T Cell Therapy, RSV Immunization, Bone Marrow Transplant - Autologous or Allogeneic
Interventions	Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) (Biological)
Dates	start 2026-01-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-06-30 (estimated), first posted 2025-12-22, last updated 2025-12-22
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Vaccine Recipients	Experimental	Biological: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)	Patients who will recieve the RSV vaccine

Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) (Biological): 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.

+Outcome measures

Primary outcomes

Fold Rise in Antibody Titers and Seroconversion [From the time the patient receives the vaccine to four weeks post-vaccination.]: 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.

Secondary outcomes

Persistence of Humoral Immune Response [From four weeks post-vaccination to six months post-vaccination]: 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.
COVID-19 and Influenza Immunity [From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV.]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Cooper University Hospital	Camden, New Jersey	United States