Recruiting NCT07195032
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Commercial measles, mumps, and rubella (MMR) vaccine.
- Who it may be relevant to
- Registry conditions: Heart Transplant Infection Prevention. Basic parameters: 1 year — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Commercial measles, mumps, and rubella (MMR) vaccine
Participants will receive the commercial MMR vaccine if they are deemed eligible for the study.
Primary outcome measures
- Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination [Time frame: Between 0-240 days after vaccine administration]
- Number of participants with resultant initial seropositivity against measles after vaccination [Time frame: Between 60-240 days after vaccine administration.]
Secondary outcome measures (1)
- Number of participants who experience prolonged seropositivity after vaccine administration [Time frame: Minimum of 365 days after vaccine administration]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Children's Mercy Hospital — Kansas City
Identifiers
NCT: NCT07195032 · STUDY00003689