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Cancer Vaccine

RSV Vaccine for Transplant Recipients (RSVax Trial)

Phase 3
Recruiting
Led By Victoria G Hall, MBBS
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post dose 1
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test a new RSV vaccine on adults who have had lung transplants or allogeneic hematopoietic stem cell transplants. Researchers will study how safe and effective the vaccine

Who is the study for?
This trial is for adult lung and allogeneic hematopoietic stem cell transplant recipients who are more than 6 months post-transplantation. They should be stable outpatients to qualify.
What is being tested?
The trial is testing the safety and immune response to a non-live RSV vaccine given to transplant recipients. Blood tests will measure immunity before and after vaccination, tracking any adverse reactions or complications.
What are the potential side effects?
Possible side effects may include local reactions at the injection site, general discomfort, increased risk of hospitalization, RSV infection despite vaccination, graft rejection or graft versus host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post dose 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post dose 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Humoral immunogenicity
Secondary study objectives
Cellular immunogenicity
Long-term safety
Safety of the vaccine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RSV vaccine groupExperimental Treatment1 Intervention
Single arm open label study of RSV vaccine to all adult transplant participants enrolling into the study.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,222 Total Patients Enrolled
Victoria G Hall, MBBSPrincipal InvestigatorUHN Toronto
~67 spots leftby Oct 2025
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