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

NCT07296120 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 25-114
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Persistence of Humoral Immune Response

  From four weeks post-vaccination to six months 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.

Study Arms (1)

Vaccine Recipients

EXPERIMENTAL

Patients who will recieve the RSV vaccine

Biological: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)

Interventions

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.

Vaccine Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Foundation: collaborator
• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Central Study Contacts

Anil K Rengan, MD

CONTACT

855-632-2667; rengan-anil@cooperhealth.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Hematology/Oncology, Cooper University Health Care

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)