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

NCT07296120 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Cooper Foundation

    collaborator UNKNOWN

  • The Cooper Health System

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-01-01
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07296120 on ClinicalTrials.gov