Safety and Immunogenicity of Non-live, Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine in Allogeneic Stem Cell Transplant and Lung Transplant Recipients

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Victoria Hall, MBBS
victoria.hall@uhn.ca
4163404800
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-03
Participants
Target number of participants: 100
Treatments
Experimental: RSV vaccine group
Single arm open label study of RSV vaccine to all adult transplant participants enrolling into the study.
Sponsors
Leads: University Health Network, Toronto
Collaborators: University of British Columbia, The PSI Foundation, Ontario

This content was sourced from clinicaltrials.gov