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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Marrow Transplant - Autologous or Allogeneic; CAR-T Cell Therapy; RSV Immunization
• Intervention / Treatment: Biological: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anil K Rengan, MD; Phone Number: 855-632-2667; Email: rengan-anil@cooperhealth.edu

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
      • Contact: Anil K Rengan, MD; Phone Number: 855-632-2667; Email: rengan-anil@cooperhealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine Recipients; Patients who will recieve the RSV vaccine	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fold Rise in Antibody Titers and Seroconversion	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.	From the time the patient receives the vaccine to four weeks post-vaccination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence of Humoral Immune Response	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.	From four weeks post-vaccination to six months post-vaccination
COVID-19 and Influenza Immunity	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.	From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV.

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Collaborators: The Cooper Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 25-114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No