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

Part of paid clinical trials in Camden, New Jersey.

Sponsor
The Cooper Health System
Study ID
NCT07296120
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Jan 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Vaccine Recipients
    Patients who will recieve the RSV vaccine

Primary Outcome Measure

Fold Rise in Antibody Titers and Seroconversion [ Time Frame: From the time the patient receives the vaccine to four weeks post-vaccination. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper University HospitalCamdenNew Jersey08103
Anil K Rengan, MD
855-632-2667

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