Vaccine for RSV in lung and stem cell transplant recipients
Safety and Immunogenicity of Non-live, Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine in Allogeneic Stem Cell Transplant and Lung Transplant Recipients
This study is testing a new RSV vaccine in adults who have had lung or stem cell transplants to see if it is safe and helps boost their immune response.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Toronto) |
| Trial ID | NCT06593210 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and immune response of an adjuvanted, non-live RSV vaccine in adult recipients of lung and allogeneic hematopoietic stem cell transplants. Participants aged 18 and older will receive a single dose of the vaccine, with blood samples collected before and after vaccination to assess immune responses. The study will monitor participants for adverse reactions, RSV infections, and other complications over a year. It has received ethical approval from Health Canada and the University Health Network.
Who should consider this trial
Good fit: Ideal candidates include stable adult lung transplant recipients more than 3 months post-transplant and allogeneic stem cell transplant recipients more than 6 months post-transplant.
Not a fit: Patients who are currently pregnant, have active infections, or have had recent treatments that affect their immune system may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could significantly improve the immune response to RSV in vulnerable transplant recipients, reducing the risk of severe infections.
How similar studies have performed: While there have been studies on RSV vaccines in older adults, this specific approach in transplant recipients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto
- University Health Network — Toronto, Canada (Recruiting)
Study contacts
- Principal investigator: Victoria G Hall, MBBS — UHN Toronto
- Study coordinator: Victoria Hall, MBBS
- Email: victoria.hall@uhn.ca
- Phone: 4163404800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.