RECRUITINGPhase 3INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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
Treatments Being Tested
BIOLOGICAL
Adjuvant, non-live RSV vaccine
One dose of arexvy vaccine to transplant recipients.
Locations (1)
University Health Network
Toronto, Canada