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NCT Number: NCT07195032

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

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.

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Key information

Conditions

Heart Transplant Infection Prevention Infections Measles Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubella Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Virus Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location status: Recruiting

Location contact

Victoria Blazek, PharmD, BCPPS

CONTACT

[email protected]

816-302-3724

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion criteria

  • 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

Treatment and study plan

Commercial measles, mumps, and rubella (MMR) vaccine

Drug

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Number of participants who experience prolonged seropositivity after vaccine administration

    Time frame: Minimum of 365 days after vaccine administration

    Serologic response will be tested at least 365 days after final vaccine administration

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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