Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

University of Minnesota74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Solid Organ Transplant

Interventions

Fluzone High-Dose - 2 dosesDRUG

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.

Fluzone High-Dose - 1 dose of HDDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Neutralizing antibody levels- Immunogenicity

Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.

Time frame: Baseline

Neutralizing antibody levels- Immunogenicity

Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.

Time frame: 4-6 weeks after dose 1

Neutralizing antibody levels- Immunogenicity

Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.

Time frame: 3 months after 2nd dose

Secondary Outcomes

clinical outcome- pneumonia

assess clinical outcome associated with an influenza infection such as pneumonia rates during the 2023-2024 and 2024-2025 influenza seasons.

Time frame: 2 years

clinical outcome- hospitalization rates

assess clinical outcome associated with an influenza infection such as hospitalization rates during the 2023-2024 and 2024-2025 influenza seasons.

Time frame: 2 years

clinical outcome- ICU admissions

assess clinical outcome associated with an influenza infection such as ICU admission rates during the 2023-2024 and 2024-2025 influenza seasons.

Time frame: 2 years

clinical - death rates

Data from ClinicalTrials.gov

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