Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

NCT05663463 | Completed

• 1 other identifier: NA-Influenza
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Organ Transplant

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  3 months after 2nd dose

Secondary Outcomes (4)

• clinical outcome- pneumonia

  2 years

• clinical outcome- hospitalization rates

  2 years

• clinical outcome- ICU admissions

  2 years

• clinical - death rates

  2 years

Study Arms (2)

booster group

EXPERIMENTAL

Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine

Drug: Fluzone High-Dose - 2 doses

Control group

ACTIVE COMPARATOR

Participants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine followed by a placebo injection

Drug: Fluzone High-Dose - 1 dose of HD

Interventions

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.

booster group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Lauren Fontana, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 23, 2022
• Study Start: September 11, 2023
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)