Solid Organ Transplant
Conditions
Brief summary
In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.
Interventions
DRUGFluzone High-Dose - 2 doses
2 doses of the High-Dose (HD) influenza vaccine separated by 4-6 weeks For 2023-2024 influenza season the influenza quadrivalent HD vaccine was used. For 2024 -2025 influenza season the influenza trivalent HD vaccine will be used.
DRUGFluzone High-Dose - 1 dose of HD
1 dose of the High Dose (HD) influenza vaccine, followed by a placebo injection 4-6 weeks later For 2023-2024 influenza season the influenza quadrivalent HD vaccine was used. For 2024 -2025 influenza season the influenza trivalent HD vaccine will be used.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody levels- Immunogenicity | Baseline | Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical outcome- pneumonia | 2 years | assess clinical outcome associated with an influenza infection such as pneumonia rates during the 2023-2024 and 2024-2025 influenza seasons. |
| clinical outcome- hospitalization rates | 2 years | assess clinical outcome associated with an influenza infection such as hospitalization rates during the 2023-2024 and 2024-2025 influenza seasons. |
| clinical outcome- ICU admissions | 2 years | assess clinical outcome associated with an influenza infection such as ICU admission rates during the 2023-2024 and 2024-2025 influenza seasons. |
| clinical - death rates | 2 years | assess clinical outcome associated with an influenza infection such as death rates during the 2023-2024 and 2024-2025 influenza seasons. |
Countries
United States
Outcome results
None listed