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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
- ClinicalTrials.gov ID
- NCT07195032
- Acronym / sponsor ID
- STUDY00003689
- Conditions
- Heart Transplant Infection Prevention
- Keywords
- Measles, Mumps, Rubella, Live vaccine, Heart transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measles, Mumps, Rubella Vaccination | Experimental | Drug: Commercial measles, mumps, and rubella (MMR) vaccinePatients receiving MMR vaccination due to no historical vaccine OR a seronegativity for measles |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial measles, mumps, and rubella (MMR) vaccineParticipants will receive the commercial MMR vaccine if they are deemed eligible for the study. | Drug | Measles, Mumps, Rubella Vaccination |
Primary outcome
Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination
Time frame: 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
Time frame: Between 60-240 days after vaccine administration.
Serologic response will be measured after vaccine administration.
1 secondary outcome
Number of participants who experience prolonged seropositivity after vaccine administration
Time frame: Minimum of 365 days after vaccine administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria Blazek, PharmD, BCPPS principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination (time frame: Between 0-240 days after vaccine administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.