Measles, Mumps, Rubella Vaccine for Infection Prevention in Pediatric Heart Transplant Patients

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Repeated infections, Anaphylactic reaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Measles, Mumps, and Rubella (MMR) vaccine is safe and effective for children who have undergone a heart transplant. The trial targets those who have not been vaccinated against MMR or lack sufficient immunity against measles. Participants should be at least one year post-heart transplant and any major subsequent treatments. It is intended for children and teens in good health following their transplant. As a Phase 4 trial, the MMR vaccine is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Measles, Mumps, Rubella (MMR) Vaccine?

Research has shown that the Measles, Mumps, and Rubella (MMR) vaccine is generally safe for children, including those who have had heart transplants. In one study, serious side effects were rare; only one child developed a liver issue months after receiving the vaccine. Most children in that study remained healthy and maintained strong protection against these diseases. Another study found that a year after vaccination, 92% of children still had protective antibodies, indicating their bodies were ready to fight off infections. Overall, the MMR vaccine appears safe for children, even those with a history of heart transplants. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using the Measles, Mumps, Rubella (MMR) vaccine in pediatric heart transplant patients because it offers a unique preventive strategy against infections. Unlike typical treatments that primarily focus on managing infections after they occur, the MMR vaccine aims to proactively build immunity in patients, potentially reducing the risk of these viral infections before they become a problem. This is particularly important for heart transplant patients who are often immunocompromised and more susceptible to infections. By enhancing protection through vaccination, this approach could lead to fewer complications and a better quality of life for these young patients.

What evidence suggests that the MMR vaccine is effective for infection prevention in pediatric heart transplant patients?

Research has shown that the Measles, Mumps, Rubella (MMR) vaccine effectively builds immunity. In earlier studies, one dose of the MMR vaccine led 89% of children who had transplants to show signs of immunity after four weeks. Furthermore, a year after vaccination, 92% of these children still had protective antibodies. This trial will evaluate the effectiveness of the MMR vaccine in pediatric heart transplant patients who either lack a historical vaccine or are seronegative for measles. The vaccine has proven to provide long-lasting immune protection in most cases. ^{1 2 3 5 6}

Who Is on the Research Team?

Victoria Blazek, PharmD, BCPPS

Principal Investigator

Children's Mercy Hospital Kansas City

Are You a Good Fit for This Trial?

This trial is for pediatric heart transplant patients aged 12 months to 17 years who haven't had the MMR vaccine. They should be at least one year post-transplant, free from recent antibody-mediated rejection treatments or certain immunosuppressants, and clinically well. Those previously vaccinated but not immune to measles can also join.

Inclusion Criteria

No history of MMR vaccination

Clinically well

I have had a heart transplant.

Exclusion Criteria

History of anaphylactic reaction to MMR vaccination

I've had many infections requiring changes in my immune system treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive the MMR vaccine according to product indication and labeling

1 day

1 visit (in-person)

Safety Monitoring

Participants are monitored for adverse reactions following vaccine administration

34 weeks

Regular follow-up visits

Follow-up

Participants are monitored for serologic response and prolonged seropositivity

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Measles, Mumps, Rubella (MMR) Vaccine

Trial Overview The study tests the safety and effectiveness of the standard commercial MMR vaccine in young heart transplant recipients. It's a non-randomized trial where participants willingly receive the MMR vaccine according to its usual prescription guidelines.

How Is the Trial Designed?

Group I: Measles, Mumps, Rubella Vaccination Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07195032

NCT07195032 | Safety and Efficacy of Measles, Mumps ... The study is an interventional, non-randomized assessment of safety and efficacy of live Measles, Mumps and Rubella (MMR) vaccine in subjects ...

2. trialx.com trialx.com/clinical-trials/listings/314845/safety-and-efficacy-of-measles-mumps-rubella-vaccination-in-pediatric-heart-transplantation-patients/

Safety and Efficacy of Measles, Mumps, Rubella ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11053538/

Live-Attenuated Vaccines in Pediatric Solid Organ Transplant One dose of MMR vaccine yielded seropositive immunity in 89% of patients after four weeks; however, 38% of patients lost their seropositive ...

4. withpower.com withpower.com/trial/phase-4-measles-8-2025-3b972

Measles, Mumps, Rubella Vaccine for Infection Prevention ... Trial Overview The study tests the safety and effectiveness of the standard commercial MMR vaccine in young heart transplant recipients. It's a non-randomized ...

5. childrenscolorado.org childrenscolorado.org/advances-answers/recent-articles/live-vaccines-transplant-patients/

Safety of Live Vaccines for Pediatric Transplant Patients One year after vaccination, most of the children retained immune protection: 92% of children demonstrated protective antibodies against the ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2810579

Safety and Immunogenicity of Live Vaccines in Pediatric ... The majority of children developed protective antibodies following vaccination (107 of 149 [72%] varicella, 130 of 152 [86%] measles, 100 of 120 ...