NCT07195032PHASE4Recruiting
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Children's Mercy Hospital Kansas City
Start Date
9/11/2025
Completion Date
9/11/2027
Summary
The study is an interventional, non-randomized assessment of safety and efficacy of live Measles, Mumps and Rubella (MMR) vaccine in subjects aged 12-months to 17 years who have undergone heart transplantation. Subjects who provide permission/assent will receive the commercial MMR vaccine according to product indication and labeling.
Eligibility Criteria
Age Range: 1 years to 17 years
Inclusion Criteria:
* Received a heart transplant
* At least 1 year after transplant
* At least 1 year after antibody-mediated rejection treatment (intravenous immune globulin, rituximab, bortezomib, plasmapheresis, carfilzomib, eculizumab, daratumumab)
* At least 1 year from anti-thymocyte globulin
* At least 6 months after pulse dose steroid treatment or basiliximab treatment
* No history of MMR vaccination OR History of MMR vaccination but seronegativity for measles at time of inclusion
* Clinically well
Exclusion Criteria:
* History of repeated infections necessitating adjustment in immunosuppression to non-standard regimen, including single agent immunosuppression and modified trough levels.
* History of anaphylactic reaction to MMR vaccination
Interventions
DRUG
Commercial measles, mumps, and rubella (MMR) vaccine
Conditions
Heart Transplant Infection Prevention
Locations
Children's Mercy Hospital
Kansas City, Missouri 64108
United States