Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Measles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MMR vaccination

MMR vaccine to seronegative pediatric SOT recipients

Group Type EXPERIMENTAL

MMR vaccination

Intervention Type BIOLOGICAL

Unprotected children will be vaccinated with two MMR vaccines

Interventions

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MMR vaccination

Unprotected children will be vaccinated with two MMR vaccines

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No