Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

University of Minnesota (UMN)

Status: Completed

Conditions: Solid Organ Transplant

Treatments: Drug: Fluzone High-Dose - 2 doses; Drug: Fluzone High-Dose - 1 dose of HD

Study type: Interventional

Funder types: Other

Identifiers

NCT05663463

NA-Influenza

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups

booster group

Experimental group

Description:

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

Treatment:

Drug: Fluzone High-Dose - 2 doses

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Fluzone High-Dose - 1 dose of HD