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NCT05663463 | RECRUITING | Solid Organ Transplant

Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
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.

Condition or disease

Solid Organ Transplant

Intervention/treatment

Fluzone High-Dose - 2 doses

Fluzone High-Dose - 1 dose of HD

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : TRIPLE
Primary Purpose : PREVENTION
Official Title : Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
Actual Study Start Date : 2023-09-11
Estimated Primary Completion Date : 2025-09-11
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

Location Details

NCT05663463

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455