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

Cooper University Health Care

Status and phase

Not yet enrolling

Phase 4

Conditions

Bone Marrow Transplant - Autologous or Allogeneic

RSV Immunization

CAR-T Cell Therapy

Treatments

Biological: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)

Study type

Interventional

Funder types

Other

Identifiers

NCT07296120

25-114

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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