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

Not Applicable

Recruiting

• Conditions: Heart Transplant Infection Prevention
• Interventions: Drug: Commercial measles, mumps, and rubella (MMR) vaccine

• Registration Number: NCT07195032
• Lead Sponsor: Children's Mercy Hospital Kansas City

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 transplantation. Subjects who provide permission/assent will receive the commercial MMR vaccine according to product indication and labeling.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-11
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Primary Completion: 2027-09-11
• Study Completion: 2027-09-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measles, Mumps, Rubella Vaccination	Commercial measles, mumps, and rubella (MMR) vaccine	Patients receiving MMR vaccination due to no historical vaccine OR a seronegativity for measles

Primary Outcome Measures

Name	Time	Method
Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination	Between 0-240 days after vaccine administration	Patients will be screened for adverse reactions following vaccine administration
Number of participants with resultant initial seropositivity against measles after vaccination	Between 60-240 days after vaccine administration.	Serologic response will be measured after vaccine administration.

Secondary Outcome Measures

Name	Time	Method
Number of participants who experience prolonged seropositivity after vaccine administration	Minimum of 365 days after vaccine administration	Serologic response will be tested at least 365 days after final vaccine administration

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States