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.

Study Overview

• Status: Recruiting
• Conditions: Solid Organ Transplant
• Intervention / Treatment: Drug: Fluzone High-Dose Quadrivalent- 2 doses; Drug: Fluzone High-Dose Quadrivalent- 1 dose of HD

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Fontana, MD; Phone Number: 6126245773; Email: fluvaccinestudy@umn.edu
• Study Contact Backup: Name: Hareesh Singam, MD; Email: singa053@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Lauren Fontana; Phone Number: 612-624-5773; Email: fluvaccinestudy@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: booster group; Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine	Drug: Fluzone High-Dose Quadrivalent- 2 doses; 2 doses of the High-Dose (HD) influenza vaccine separated by 4-6 weeks
Active Comparator: 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	Drug: Fluzone High-Dose Quadrivalent- 1 dose of HD; 1 dose of the High Dose (HD) influenza vaccine, followed by a placebo injection 4-6 weeks later

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome- pneumonia	assess clinical outcome associated with an influenza infection such as pneumonia rates during the 2023-2024 and 2024-2025 influenza seasons.	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.	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.	2 years
clinical - death rates	assess clinical outcome associated with an influenza infection such as death rates during the 2023-2024 and 2024-2025 influenza seasons.	2 years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Lauren Fontana, MD, University of Minnesota; Principal Investigator: Hareesh Singam, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): September 11, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: NA-Influenza

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No