RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients
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
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
Treatments tested in this trial
- Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
The Cooper Health System
Lead sponsor
Cooper University Health Care
Sponsor institution
The Cooper Foundation
Collaborator
Source ClinicalTrials.gov