Measles
Conditions
Keywords
Measles, Mumps, Rubella, Pediatric, Solid-organ transplant, serology, vaccine
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.
Interventions
BIOLOGICALMMR vaccination
Unprotected children will be vaccinated with two MMR vaccines
Sponsors
University Hospital, Geneva
Klara M. Pósfay Barbe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serologic response to MMR vaccine in seronegative transplant recipients | 2 months after vaccination | Pediatric transplant recipients will be vaccinated with MMR vaccine (previously seronegative) and their seroresponse will be measured 2 months later |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistance of seroresponse to MMR vaccine | 3 years | Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of MMR vaccine in pediatric SOT recipients | 3 years | Protection against vaccine-preventable diseases will be assessed in pediatric SOT recipients |
Countries
Switzerland
Outcome results
None listed