Vaccination against measles in children who have had a liver transplant
Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland
This study tests how well the measles vaccine works in children who have had a liver transplant to see if they can build immunity against measles.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 12 Months to 20 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva, GE) |
| Trial ID | NCT01770119 on ClinicalTrials.gov |
What this trial studies
This study evaluates the immune response to the measles vaccine in pediatric patients who have undergone liver transplantation. It focuses on children at least 12 months post-transplantation and assesses their ability to develop B and T cell immunity after receiving the MMR vaccine. Participants will be monitored for antibody levels and may receive additional doses of the vaccine based on their immune response. The study aims to ensure that these immunosuppressed children can safely develop immunity against measles, a potentially life-threatening disease.
Who should consider this trial
Good fit: Ideal candidates are children aged 12 months or older who are at least one year post-liver transplantation and have low measles-specific IgG antibody levels.
Not a fit: Patients who have recently been exposed to wild-type measles or have received measles-containing immunoglobulins may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe method for immunizing pediatric liver transplant recipients against measles, reducing their risk of severe infection.
How similar studies have performed: While there have been studies on vaccination in immunocompromised populations, this specific approach in pediatric liver transplant recipients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 12 months * Measles-specific IgG antibodies negative (\<0.2 IU/L), as detected by the routine ELISA assay * ≥ 12 months from the time of transplantation and ≥ 2 months from the time of an acute rejection episode * Steroids \< 2 mg/kg/day, tacrolimus \< 0.3mg/kg/day and tacrolimus level \< 8 ng/ml for \> 1 month. * Total lymphocyte count ≥ 750 cells/ul at time of immunization Exclusion Criteria: * Known wild-type measles exposure during the last four weeks * Measles-containing immunoglobulins administered within the 5 months preceding the measles vaccine. If the child receives measles-containing Ig before an additional dose of MMR vaccine, he/she will be withdrawn from the study * Antiviral agents administered during the last four weeks * Febrile illness (\>38.5°) in the 72 hours before vaccine administration * Chronic aspirin therapy * Any other immunization with a live-attenuated vaccine during the last four weeks * Pregnancy
Where this trial is running
Geneva, GE
- Children's Hospital of Geneva — Geneva, Ge, Switzerland (Recruiting)
Study contacts
- Principal investigator: Klara M Posfay-Barbe, MD, MS — University Hospitals of Geneva
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.