Clinical trial NCT01770119: Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients
Official title: Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Measles
Keywords: Measles
Mumps
Rubella
Pediatric
Solid-organ transplant
serology
vaccine
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2013-01-17
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 description: 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.

Eligibility 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

Primary outcomes:
measure: serologic response to MMR vaccine in seronegative transplant recipients
timeFrame: 2 months after vaccination
Secondary outcomes:
measure: Persistance of seroresponse to MMR vaccine
timeFrame: 3 years
Other outcomes:
measure: Efficacy of MMR vaccine in pediatric SOT recipients
timeFrame: 3 years
Locations:
city: Geneva
country: Switzerland
facility: Children's Hospital of Geneva
state: GE
Study officials:
affiliation: University Hospitals of Geneva
name: Klara M Posfay-Barbe, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pittet LF, Verolet CM, McLin VA, Wildhaber BE, Rodriguez M, Cherpillod P, Kaiser L, Siegrist CA, Posfay-Barbe KM. Multimodal safety assessment of measles-mumps-rubella vaccination after pediatric liver transplantation. Am J Transplant. 2019 Mar;19(3):844-854. doi: 10.1111/ajt.15101. Epub 2018 Oct 1.
citation: Suresh S, Upton J, Green M, Pham-Huy A, Posfay-Barbe KM, Michaels MG, Top KA, Avitzur Y, Burton C, Chong PP, Danziger-Isakov L, Dipchand AI, Hebert D, Kumar D, Morris SK, Nalli N, Ng VL, Nicholas SK, Robinson JL, Solomon M, Tapiero B, Verma A, Walter JE, Allen UD. Live vaccines after pediatric solid organ transplant: Proceedings of a consensus meeting, 2018. Pediatr Transplant. 2019 Nov;23(7):e13571. doi: 10.1111/petr.13571. Epub 2019 Sep 9.