Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

NCT ID: NCT05663463

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2025-06-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

booster group

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

Group Type: EXPERIMENTAL

Fluzone High-Dose - 2 doses

Intervention Type: 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.

Control group

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

Group Type: ACTIVE_COMPARATOR

Fluzone High-Dose - 1 dose of HD

Intervention Type: 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.

Interventions

Fluzone 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.

Intervention Type: DRUG

Fluzone 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.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Fontana, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

NA-Influenza

Identifier Type: -

Identifier Source: org_study_id