RSV Vaccine in Transplant Recipients
Safety and Immunogenicity of Non-live, Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine in Allogeneic Stem Cell Transplant and Lung Transplant Recipients
University Health Network, Toronto
100 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
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. Blood work will be collected before and after the intervention, to assess humoral and cellular immunity. Participants will be followed for adverse reaction, hospitalization, RSV breakthrough infection, graft rejection or graft versus host disease. This study has Health Canada and UHN REB approval.
Eligibility
Inclusion Criteria4
- 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 Criteria10
- 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
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Interventions
One dose of arexvy vaccine to transplant recipients.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06593210