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

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07296120
Lead Sponsor The Cooper Health System
Collaborators: The Cooper Foundation
Conditions CAR-T Cell Therapy, RSV Immunization, Bone Marrow Transplant - Autologous or Allogeneic
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov