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

Children's Mercy Hospital Kansas City

Status and phase

Enrolling

Phase 4

Conditions

Heart Transplant Infection Prevention

Treatments

Drug: Commercial measles, mumps, and rubella (MMR) vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT07195032

STUDY00003689

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

1 to 17 years old

Volunteers

No Healthy Volunteers

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