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Tests treatment safety and results for Heart Transplant Infection Prevention
Official title Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
ClinicalTrials.gov ID: NCT07195032
What this study is testing
What is Commercial measles, mumps, and rubella (MMR) vaccine?
Commercial measles, mumps, and rubella (MMR) vaccine is an investigational medicine, being studied as a potential treatment for heart transplant infection prevention.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join 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...
- At least 1 year from anti-thymocyte globulin
- At least 6 months after pulse dose steroid treatment or basiliximab treatment
You likely can't join if
- History of repeated infections necessitating adjustment in immunosuppression to non-standard regimen, including single agent immunosuppression and...
- History of anaphylactic reaction to MMR vaccination
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.