RSV Vaccine in Transplant Recipients (RSVax)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Virus Infections; Vaccine Response Impaired; Immune Suppression
• Intervention / Treatment: Biological: Adjuvant, non-live RSV vaccine

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) recipients.Patients 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, 6 months and 12 months 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 episode(s) 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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
    • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSV vaccine group; Single arm open label study of RSV vaccine to all adult transplant participants enrolling into the study.	Biological: Adjuvant, non-live RSV vaccine; One dose of arexvy vaccine to transplant recipients.; Other Names: Arexvy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Humoral immunogenicity	Neutralizing antibody response	4 weeks after dose 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular immunogenicity	T cell immune response	4 weeks after dose 1
Safety of the vaccine	Side effects after vaccine	7 days after dose 1
Long-term safety	Hospitalization, adverse events, RSV breakthrough infection, GvHD, graft rejection	1 year post dose 1
Durability of immunity	Humoral and cellular immunogenicity at 6 and 12 months post vaccination	12 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: University of British Columbia; The Physicians' Services Incorporated Foundation
• Investigators: Principal Investigator: Victoria G Hall, MBBS, UHN Toronto

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections; Pharmaceutical Preparations; Chemical Actions and Uses; Specialty Uses of Chemicals; Pharmaceutic Aids; Adjuvants, Pharmaceutic; arexvy
• Other Study ID Numbers: 24-5021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No