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) — BIOLOGICALPatients 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 RecipientsPatients 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
- Anil K Rengan, MD855-632-2667
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 |
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