Clinical Trial: Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Klara M. Pósfay Barbe
Current Primary Outcome: serologic response to MMR vaccine in seronegative transplant recipients [ Time Frame: 2 months after vaccination ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Persistance of seroresponse to MMR vaccine [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Geneva
Dates:
Date Received: January 15, 2013
Date Started: April 2013
Date Completion: October 2017
Last Updated: December 29, 2016
Last Verified: December 2016