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NCT Number: NCT07296120

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Fold Rise in Antibody Titers and Seroconversion

    Time frame: From the time the patient receives the vaccine to four weeks post-vaccination.

    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.

Secondary outcomes

  1. Persistence of Humoral Immune Response

    Time frame: From four weeks post-vaccination to six months post-vaccination

    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.

  2. COVID-19 and Influenza Immunity

    Time frame: From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anil K Rengan, MD

CONTACT

[email protected]

855-632-2667

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Collaborators

  • The Cooper Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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