Comparing high and standard dose influenza vaccines for lung transplant recipients
Comparison of High Dose vs. Standard Dose Influenza Vaccines in Lung Allograft Recipients
This study is testing whether a high-dose flu vaccine works better and is safer for lung transplant recipients compared to the standard-dose flu vaccine.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05215327 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the immunogenicity and safety of two doses of high-dose quadrivalent inactivated influenza vaccine (HD-QIV) versus two doses of standard-dose quadrivalent inactivated influenza vaccine (SD-QIV) in lung allograft recipients. The study aims to determine if the high-dose vaccine leads to better immune responses and is well tolerated compared to the standard dose. Participants will be lung transplant recipients aged 16 years or older, enrolled between 1 to 35 months post-transplant. The trial will also explore the relationship between immune cell markers and vaccine response.
Who should consider this trial
Good fit: Ideal candidates are lung allograft recipients aged 16 years or older, between 1 to 35 months post-transplant.
Not a fit: Patients who have received a multi-organ transplant or have a history of severe allergic reactions to influenza vaccines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance influenza immunity in lung transplant recipients, reducing morbidity and mortality associated with influenza infections.
How similar studies have performed: While few studies have focused specifically on lung allograft recipients, similar approaches in other transplant populations have shown promise in improving vaccine responses.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Natasha Halasa, MD. MPH — Vanderbilt University Medical Center
- Study coordinator: Natasha Halasa, MD, MPH
- Email: natasha.halasa@vumc.org
- Phone: 615-322-2250
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.