RSV Vaccine in Transplant Recipients

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new RSV vaccine designed specifically for adult patients who have received lung transplants or stem cell transplants. The goal is to see how safe the vaccine is and how well it works in helping the immune system respond to the Respiratory Syncytial Virus (RSV), which can be dangerous for people with weakened immune systems. Participants in the trial will receive the vaccine and then have blood tests taken before and after to check their immune response. They will also be monitored for any side effects, hospital visits, or complications related to their transplant.

To be eligible for this trial, participants should be at least 18 years old and stable, meaning they have been healthy for a certain period after their transplant (more than 3 months for lung transplants and more than 6 months for stem cell transplants). They need to be able to follow up with blood tests after receiving the vaccine and give consent to participate. However, certain individuals, such as those who are pregnant, breastfeeding, or have had recent infections or treatments that might affect their immune system, cannot participate. Overall, this study is an important step in understanding how to protect transplant recipients from RSV infections.

Gender

ALL

Eligibility 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