COMPLETED

Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients

Quick Facts

Study Start:2023-09-11
Study Completion:2025-06-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05663463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) \> 1 year prior to enrollment
  2. * At least 1-year post-transplant
  3. * Able and willing to provide informed consent
  4. * Able and willing to undergo all study activities throughout the duration of the study
  1. * Confirmed pregnancy
  2. * Receipt of ATG or carfilzomib within the past 3 months
  3. * Receipt of rituximab within the past 3 months
  4. * Receipt of basiliximab within the past 3 months
  5. * Prednisone dose \>= 20 mg/day at the time of enrollment
  6. * History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)

Contacts and Locations

Principal Investigator

Lauren Fontana, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Lauren Fontana, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-11
Study Completion Date2025-06-16

Study Record Updates

Study Start Date2023-09-11
Study Completion Date2025-06-16

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Organ Transplant