Health TrialsbyHealthPanel

Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients

ConditionHeart Transplant Infection Prevention
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-17
SponsorChildren's Mercy Hospital Kansas City

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Commercial measles, mumps, and rubella (MMR) vaccine

    Drug

    Participants will receive the commercial MMR vaccine if they are deemed eligible for the study.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Measles, Mumps, Rubella VaccinationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination

Patients will be screened for adverse reactions following vaccine administration

Time frame
Between 0-240 days after vaccine administration
2

Number of participants with resultant initial seropositivity against measles after vaccination

Serologic response will be measured after vaccine administration.

Time frame
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

Time frame
Minimum of 365 days after vaccine administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Mercy Hospital Kansas City

Lead sponsor

Source ClinicalTrials.gov
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