High dose influenza vaccine for solid organ transplant recipients
Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
This study tests whether giving two doses of a stronger flu vaccine can help solid organ transplant recipients build better immunity compared to just one dose.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Drugs / interventions | rituximab, basiliximab, Prednisone |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05663463 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of administering two doses of a high-dose influenza vaccine to solid organ transplant recipients to enhance their immune response. Participants will be compared to a control group receiving only one dose of the vaccine. The primary goal is to measure the immunogenicity of the vaccine using neutralizing antibody assays, which will help determine the best vaccination strategy for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone a solid organ transplant at least one year prior to enrollment.
Not a fit: Patients who are pregnant or have received certain immunosuppressive therapies within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the immune response to influenza in solid organ transplant recipients, reducing the severity of the disease.
How similar studies have performed: Previous studies have shown that optimizing vaccine strategies can improve outcomes in solid organ transplant recipients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) \> 1 year prior to enrollment * At least 1-year post-transplant * Able and willing to provide informed consent * Able and willing to undergo all study activities throughout the duration of the study Exclusion Criteria: * Confirmed pregnancy * Receipt of ATG or carfilzomib within the past 3 months * Receipt of rituximab within the past 3 months * Receipt of basiliximab within the past 3 months * Prednisone dose \>= 20 mg/day at the time of enrollment * History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Fontana, MD — University of Minnesota
- Study coordinator: Lauren Fontana, MD
- Email: fluvaccinestudy@umn.edu
- Phone: 6126245773
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.