NCT07296120

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CAR-T Cell Therapy
• RSV Immunization
• Bone Marrow Transplant - Autologous or Allogeneic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-06-30
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study