Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients (MMRinOLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01770119
Recruitment Status : Recruiting
First Posted : January 17, 2013
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Klara M. Pósfay Barbe, University Hospital, Geneva

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Measles Biological: MMR vaccination Phase 4

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2013
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: MMR vaccination
MMR vaccine to seronegative pediatric SOT recipients
 Biological: MMR vaccination
Unprotected children will be vaccinated with two MMR vaccines


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. serologic response to MMR vaccine in seronegative transplant recipients [ Time Frame: 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 Outcome Measures :
  1. Persistance of seroresponse to MMR vaccine [ Time Frame: 3 years ]
    Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients


Other Outcome Measures:
  1. Efficacy of MMR vaccine in pediatric SOT recipients [ Time Frame: 3 years ]
    Protection against vaccine-preventable diseases will be assessed in pediatric SOT recipients


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770119


Locations
Layout table for location information
Switzerland
Children's Hospital of Geneva Recruiting
Geneva, GE, Switzerland, 1211
Contact: Klara M Posfay-Barbe, MD, MS    +41223725462    Klara.PosfayBarbe@hcuge.ch   
Contact: Natasha Loevy, MD    +41223725481    Natasha.Loevy@hcuge.ch   
Principal Investigator: Klara M Posfay-Barbe, MD, MS         
Sponsors and Collaborators
Klara M. Pósfay Barbe
University Hospital, Geneva
Investigators
Layout table for investigator information
Principal Investigator: Klara M Posfay-Barbe, MD, MS University Hospitals of Geneva
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Klara M. Pósfay Barbe, Head of Pediatric Infectious Diseases, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01770119    
Other Study ID Numbers: MMR in pediatric OLT
12-226 (MatPed 12-048) ( Other Identifier: IRB )
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Klara M. Pósfay Barbe, University Hospital, Geneva:
Measles
Mumps
Rubella
Pediatric
 Solid-organ transplant
serology
vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
 Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs