Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota

Criteria

Inclusion Criteria:

• >=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) prior to September 1 st ,2021.

• Without history of any of the conditions listed in the exclusion criteria.

• At least 1-year post-transplant

• Able and willing to sign informed consent form

• Available for lab visits for 4 months after initial enrollment

Exclusion Criteria:

• Confirmed pregnancy

• Receipt of ATG or carfilzomib within 3 months

• Receipt of rituximab within 3 months

• Receipt of basiliximab within 3 months

• Prednisone dose > 20 mg at the time of enrollment

• History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)