Status:
RECRUITING
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Heart Transplant Infection Prevention
Eligibility:
All Genders
1-17 years
Phase:
PHASE4
Brief 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 transp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 11 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07195032
Start Date
September 11 2025
End Date
September 11 2027
Last Update
September 26 2025
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108