Heart Transplant Infection PreventionPhase 4NCT07195032
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
A Phase 4 study testing Commercial measles, mumps, and rubella (MMR) vaccine in people with Heart Transplant Infection Prevention, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Heart Transplant Infection Prevention
- What is being tested?
- Commercial measles, mumps, and rubella (MMR) vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 11 Sep 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Victoria Blazek, PharmD, BCPPS, 816-302-3724, vmblazek@cmh.edu
About this study
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
- Being tested
- Commercial measles, mumps, and rubella (MMR) vaccine
- Keywords
- Measles, Mumps, Rubella, Live vaccine, Heart transplant
- Medical subject headings
- Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial measles, mumps, and rubella (MMR) vaccineDrug
Participants will receive the commercial MMR vaccine if they are deemed eligible for the study.
| Study group | Role | What they receive |
|---|---|---|
| Measles, Mumps, Rubella Vaccination | Experimental | Patients receiving MMR vaccination due to no historical vaccine OR a seronegativity for measles Receives: Drug: Commercial measles, mumps, and rubella (MMR) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination
Patients will be screened for adverse reactions following vaccine administration
Measured: 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.
Measured: Between 60-240 days after vaccine administration.
Secondary outcomes (1)
Number of participants who experience prolonged seropositivity after vaccine administration
Serologic response will be tested at least 365 days after final vaccine administration
Measured: Minimum of 365 days after vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start11 Sep 2025
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant Infection PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Blazek, Children's Mercy Hospital Kansas City
- Investigators
- Victoria Blazek, PharmD, BCPPS, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195032
- Sponsor's protocol ID
- STUDY00003689
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided