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Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients

RECRUITINGPhase 4Sponsored by Children's Mercy Hospital Kansas City
Actively Recruiting
PhasePhase 4
SponsorChildren's Mercy Hospital Kansas City
Started2025-09-11
Est. completion2027-09-11
Eligibility
Age1 Year – 17 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07195032

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

Age: 1 Year – 17 YearsHealthy volunteers accepted
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

Conditions2

Heart DiseaseHeart Transplant Infection Prevention

Locations1 site

Children's Mercy Hospital
Kansas City, Missouri, 64108
Victoria Blazek, PharmD, BCPPS816-302-3724vmblazek@cmh.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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