Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

Not Applicable

Recruiting

• Conditions: Solid Organ Transplant
• Interventions: Drug: Fluzone High-Dose - 2 doses; Drug: Fluzone High-Dose - 1 dose of HD

• Registration Number: NCT05663463
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-23
• Study Start: 2023-09-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2025-09-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
booster group	Fluzone High-Dose - 2 doses	Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine
Control group	Fluzone High-Dose - 1 dose of HD	Participants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine followed by a placebo injection

Primary Outcome Measures

Name	Time	Method
Neutralizing antibody levels- Immunogenicity	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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States