Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients (MMRinOLT)
Measles is a vaccine-preventable disease, which can be life-threatening in immunosuppressed children. Currently, measles vaccine is not recommended in pediatric orthotopic liver transplant recipients, because it is a live-attenuated vaccine.
We want to assess the influence of immunosuppression on immunity against measles in previously vaccinated children and to evaluate the induction of B cell and T cell response against measles elicited by vaccination in children at least 12 months after transplantation.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland|
- serologic response to MMR vaccine in seronegative transplant recipients [ Time Frame: 2 months after vaccination ] [ Designated as safety issue: Yes ]Pediatric transplant recipients will be vaccinated with MMR vaccine (previously seronegative) and their seroresponse will be measured 2 months later
- Persistance of seroresponse to MMR vaccine [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients
- Efficacy of MMR vaccine in pediatric SOT recipients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Protection against vaccine-preventable diseases will be assessed in pediatric SOT recipients
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Experimental: MMR vaccination
MMR vaccine to seronegative pediatric SOT recipients
Biological: MMR vaccination
Unprotected children will be vaccinated with two MMR vaccines
Eligible children in Group 2 will receive a standard dose (0.5 ml) of MMR vaccine during the first medical visit (V1). The lot number and the expiration date will both be recorded on the patient's case report form (CRF). A serological evaluation 4-8 weeks after MMR will identify children requiring an additional dose given 1-2 months apart, as currently recommended for subjects 1 year-old or with limited immune competence (i.e. HIV-infected children). Serological evaluation 4-8 weeks after the second dose or at the one-year follow-up will identify eventual non-responder requiring a third dose. Three will be the maximal number of administrated dose according to this protocol. The persistence of measles-specific antibodies will be assessed yearly, when patients come for their routine visit to the transplant center.
Children who do not need MMR immunization because of protective levels will be monitored yearly for maintenance of antibody levels during routine yearly visits/ blood samplings and will not have further intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770119
|Children's Hospital of Geneva||Recruiting|
|Geneva, GE, Switzerland, 1211|
|Contact: Klara M Posfay-Barbe, MD, MS +41223725462 Klara.PosfayBarbe@hcuge.ch|
|Contact: Charlotte Verolet, MD +41223725481 Charlotte.Verolet@hcuge.ch|
|Principal Investigator: Klara M Posfay-Barbe, MD, MS|
|Principal Investigator:||Klara M Posfay-Barbe, MD, MS||University Hospitals of Geneva|