MMR vaccination for children after heart transplant
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
We will give the MMR (measles, mumps, rubella) vaccine to children and teens who had a heart transplant to see if it's safe and helps them make protective antibodies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Drugs / interventions | rituximab, eculizumab, daratumumab, basiliximab |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT07195032 on ClinicalTrials.gov |
What this trial studies
This is a non-randomized interventional study enrolling children and adolescents (12 months to 17 years) who have undergone heart transplantation. Eligible participants who are clinically well and meet timing criteria after transplant and prior immunomodulatory treatments will receive the licensed commercial MMR vaccine according to product labeling. The study will monitor safety outcomes and measure antibody responses to determine whether vaccination induces protective immunity without causing adverse events. Results aim to inform guidance on when live MMR vaccine can be given after pediatric heart transplantation.
Who should consider this trial
Good fit: Children and adolescents (12 months–17 years) who had a heart transplant at least one year ago, meet the required time intervals since specific immunosuppressive or rejection treatments, are clinically well, and are either unvaccinated or measles-seronegative.
Not a fit: Patients with recent or ongoing intensive immunosuppression, a history of repeated infections requiring non-standard immunosuppression adjustments, or a prior anaphylactic reaction to MMR are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, vaccination could safely restore measles, mumps, and rubella immunity and reduce the risk of these infections in pediatric heart transplant recipients.
How similar studies have performed: Small reports and studies in other pediatric solid-organ transplant populations suggest live vaccines can be safe and immunogenic in carefully selected patients, but data specifically in heart transplant recipients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kansas City, Missouri
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Victoria Blazek, PharmD, BCPPS — Children's Mercy Hospital Kansas City
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.