Status:
RECRUITING
RSV Vaccine in Transplant Recipients
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
The PSI Foundation, Ontario
University of British Columbia
Conditions:
Vaccine Response Impaired
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Adjuvant, non-live RSV vaccine will be administered to adult lung and allogeneic hematopoietic stem cell transplant recipients. The safety and immunogenicity of this intervention will be studied. Bloo...
Detailed Description
This is a single-arm, open-label, investigational and interventional study to determine the immunogenicity of one dose of RSV vaccine in adult Allogeneic Stem Cell Transplant (alloSCT) or lung transpl...
Eligibility Criteria
Inclusion
- Stable outpatient lung transplant recipients more than 3 months post-transplantation and stable outpatient allogeneic HCT recipients more than 6 months post-transplantation
- Adult equal or over 18 years of age
- Able to comply with blood work at 4-6 weeks post-vaccination
- Able to provide informed consent
Exclusion
- Currently pregnant or planning to conceive or breastfeeding
- IVIg or plasmapharesis in last 30 days or expecting in next 30 days
- Previous rituximab in last 6 months
- Active CMV infection with VL \> 1000 IU/ml
- Diagnosis of RSV in the past 90 days
- Unwell with acute infection (respiratory or other)
- Any vaccination in last 2 weeks
- History of severe allergic reaction (anaphylaxis) to any vaccination
- Active rejection in last 30 days for lung transplant recipient
- Active GvHD or poor graft function for alloSCT recipient
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06593210
Start Date
October 1 2024
End Date
March 1 2026
Last Update
November 26 2025
Active Locations (1)
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1
University Health Network
Toronto, Canada