High Vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jan 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different doses of the influenza vaccine in people who have received a lung transplant. Lung transplant recipients are at a higher risk for severe influenza, especially in the early months after their surgery, because the medications they take to prevent organ rejection can weaken their immune system. The researchers want to find out if giving a higher dose of the vaccine (called high-dose quadrivalent inactivated influenza vaccine) in two shots during the same flu season will help these patients develop better protection against the flu compared to the standard dose vaccine.

To participate in this study, individuals must be at least 16 years old, have received a lung transplant between 1 and 35 months ago, and be available for follow-up during the study. Participants will receive either the high-dose or standard-dose vaccine in two separate injections and will be monitored for their immune response and safety. This trial is important because it aims to improve vaccination strategies for lung transplant recipients, helping to reduce their risk of serious flu-related complications. If you're interested in participating or learning more, please consult with your healthcare team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Lung allograft recipients
• • 2. Age ≥16 years at time of enrollment
• • 3. ≥1 month (30 days) and \<36 months post-lung transplant
• • 4. Anticipated to be available for duration of the study
• • 5. Can be reached by telephone, email, or text message
• Exclusion Criteria:
• • 1. Recipient of multi-organ, extra-pulmonary, and/or hematopoietic stem cell transplant
• • 2. Recipient of a re-do lung transplant
• • 3. History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein
• • 4. History of Guillain-Barre syndrome
• • 5. HIV positive patients, by history or documentation from previous test
• • 6. History of known severe latex hypersensitivity
• • 7. History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study
• • 8. Pregnant female
• • 9. Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled)
• • 10. CMVIG/IVIG/SCIG receipt within 28 days of each vaccine
• • 11. Receipt of rituximab or other B-cell depleting antibody (including proteasome inhibitors) therapy within 3-months of 1st study vaccine (Day 0).
• • 12. Receipt of augmented T-cell depleting therapy within 3-months of 1st study vaccine (Day 0)
• • 13. Investigator concern about study participation