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Completed

NCT Number: NCT05663463

Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

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.

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Key information

Conditions

Solid Organ Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fluzone High-Dose - 2 doses

Drug

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 HD

Drug

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.

Primary outcomes

  1. Neutralizing antibody levels- Immunogenicity

    Time frame: 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.

  2. Neutralizing antibody levels- Immunogenicity

    Time frame: 4-6 weeks after dose 1

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

  3. Neutralizing antibody levels- Immunogenicity

    Time frame: 3 months after 2nd dose

    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 outcomes

  1. clinical outcome- pneumonia

    Time frame: 2 years

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

  2. clinical outcome- hospitalization rates

    Time frame: 2 years

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

  3. clinical outcome- ICU admissions

    Time frame: 2 years

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

  4. clinical - death rates

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2022
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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