Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593210
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
RSV Vaccine in Transplant Recipients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Immunogenicity of Non-live Adjuvanted Respiratory Syncytial Virus RSV Vaccine in Allogeneic Stem Cell Transplant and Lung Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RSVax
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 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
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 transplant LT recipientsPatients at least 18 years of age will receive a single dose of adjuvanted RSV vaccine RSVPreF3 Arexvy GSK This vaccine is currently approved in Canada for adults over 60 years of age Therefore administration to adult transplant recipients between the age of 18 and 60 years of age is considered off-label We have ethics approval to conduct this study from UHN and a No Objection Letter from Health Canada
Study investigators physicians will perform the vaccination at hospital outpatient clinics
Whole blood total 30mL or 3 tubes will be collected prior to vaccination and then at 4 weeks post-vaccination for humoral and cell-mediated immunity assessment At each time point 1 red-top blood tube 6mls for serum and 2 green-top sodium heparin 9mls blood tubes for plasma and peripheral blood mononuclear cells PBMCs will be collected
Eligible patients will be screened as per the inclusion and exclusion criteria detailed in the screening log After written informed consent and enrolment the patient will be allocated a study code and data will be collected for demographics including age sex gender identity race language spoken at home immunosuppression at time of vaccination time from transplant immunosuppression regimen at time of transplant underlying disease recent lymphocyte count and immunoglobulin levels at the time of vaccination and follow up blood work For alloSCT recipients treatment history for Graft versus Host Disease GvHD and underlying disease status will be collected For LT recipients information regarding recent lung function and rejection episodes will be collected Patients will be contacted at 6 weeks post-vaccination to determine the rates of adverse events including hospitalizations cardiac or neurologic events Patients will then be contacted at 12 months and interviewed to determine whether they had a diagnosis of RSV infection following vaccination Total follow-up time for each patient will be 1 year from vaccination
Study investigators physicians will perform the vaccination at hospital outpatient clinics
Whole blood total 30mL or 3 tubes will be collected prior to vaccination and then at 4 weeks post-vaccination for humoral and cell-mediated immunity assessment At each time point 1 red-top blood tube 6mls for serum and 2 green-top sodium heparin 9mls blood tubes for plasma and peripheral blood mononuclear cells PBMCs will be collected
Eligible patients will be screened as per the inclusion and exclusion criteria detailed in the screening log After written informed consent and enrolment the patient will be allocated a study code and data will be collected for demographics including age sex gender identity race language spoken at home immunosuppression at time of vaccination time from transplant immunosuppression regimen at time of transplant underlying disease recent lymphocyte count and immunoglobulin levels at the time of vaccination and follow up blood work For alloSCT recipients treatment history for Graft versus Host Disease GvHD and underlying disease status will be collected For LT recipients information regarding recent lung function and rejection episodes will be collected Patients will be contacted at 6 weeks post-vaccination to determine the rates of adverse events including hospitalizations cardiac or neurologic events Patients will then be contacted at 12 months and interviewed to determine whether they had a diagnosis of RSV infection following vaccination Total follow-up time for each patient will be 1 year from vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None