RSV Vaccine in Transplant Recipients

NCT06593210 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: 24-5021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Response Impaired; Respiratory Syncytial Virus Infections; Immune Suppression

Outcome Measures

Primary Outcomes (1)

• Humoral immunogenicity

  Neutralizing antibody response

  4 weeks after dose 1

Secondary Outcomes (4)

• Cellular immunogenicity

  4 weeks after dose 1

• Safety of the vaccine

  7 days after dose 1

• Long-term safety

  1 year post dose 1

• Durability of immunity

  12 months

Study Arms (1)

RSV vaccine group

EXPERIMENTAL

Single arm open label study of RSV vaccine to all adult transplant participants enrolling into the study.

Biological: Adjuvant, non-live RSV vaccine

Interventions

Adjuvant, non-live RSV vaccine BIOLOGICAL

One dose of arexvy vaccine to transplant recipients.

Also known as: Arexvy

RSV vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: collaborator
• The Physicians' Services Incorporated Foundation: collaborator
• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Canada

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Adjuvants, Pharmaceutic; arexvy

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Victoria G Hall, MBBS

  UHN Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Investigator

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)