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

NCT07195032 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00003689
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant Infection Prevention

Keywords

Measles; Mumps; Rubella; Live vaccine; Heart transplant

Outcome Measures

Primary Outcomes (2)

• Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination

  Patients will be screened for adverse reactions following vaccine administration

  Between 0-240 days after vaccine administration

• Number of participants with resultant initial seropositivity against measles after vaccination

  Serologic response will be measured after vaccine administration.

  Between 60-240 days after vaccine administration.

Secondary Outcomes (1)

• Number of participants who experience prolonged seropositivity after vaccine administration

  Minimum of 365 days after vaccine administration

Study Arms (1)

Measles, Mumps, Rubella Vaccination

EXPERIMENTAL

Patients receiving MMR vaccination due to no historical vaccine OR a seronegativity for measles

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

Interventions

Commercial measles, mumps, and rubella (MMR) vaccine DRUG

Participants will receive the commercial MMR vaccine if they are deemed eligible for the study.

Measles, Mumps, Rubella Vaccination

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Clinically well

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Measles; Mumps; Rubella

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Victoria Blazek, PharmD, BCPPS

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): September 11, 2027
• Study Completion (Estimated): September 11, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)