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NCT05663463
Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
Conditions: Solid Organ Transplant
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 94
Sponsor: University of Minnesota
Location: United States
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.
Eligibility 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-transplantAble and willing to sign informed consent formAvailable for lab visits for 4 months after initial enrollmentExclusion Criteria:Confirmed pregnancyReceipt of ATG or carfilzomib within 3 monthsReceipt of rituximab within 3 monthsReceipt of basiliximab within 3 monthsPrednisone dose > 20 mg at the time of enrollmentHistory of a severe allergy to influenza vaccine (i.e.
Guillain Barre syndrome, anaphylaxis or angioedema)
Source: ClinicalTrials.gov (NCT05663463). StuddyBuddy aggregates publicly available trial information.