This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 3

RSV Vaccine

Sponsor:

University Health Network, Toronto

Code:

NCT06593210

Conditions

Vaccine Response Impaired

Respiratory Syncytial Virus Infections

Immune Suppression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adjuvant, non-live RSV vaccine

Study Details

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

Study ID

NCT06593210

Start date

Oct 1, 2024

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: RSV vaccine group

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

Interventions

Adjuvant, non-live RSV vaccine

One dose of arexvy vaccine to transplant recipients.

Primary outcome measure

  • Humoral immunogenicity [ Time Frame: 4 weeks after dose 1 ]

Central Contacts and Locations

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.