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

ConditionsCAR-T Cell TherapyRSV ImmunizationBone Marrow Transplant - Autologous or Allogeneic
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cooper Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Diagnosis of hematological malignancy

Treatment with HSCT or CAR-T therapy

Must be able to give informed consent

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)

    Biological/Vaccine

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Vaccine RecipientsExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From four weeks post-vaccination to six months post-vaccination
2

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cooper Health System

Lead sponsor

Cooper University Health Care

Sponsor institution

The Cooper Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: