Trial record 4 of 25 for:    Open Studies | "Measles"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Geneva
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Klara M. Pósfay Barbe, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01770119
First received: January 15, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Measles
Biological: MMR vaccination
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • serologic response to MMR vaccine in seronegative transplant recipients [ Time Frame: 2 months after vaccination ] [ Designated as safety issue: Yes ]
    Pediatric transplant recipients will be vaccinated with MMR vaccine (previously seronegative) and their seroresponse will be measured 2 months later


Secondary Outcome Measures:
  • Persistance of seroresponse to MMR vaccine [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients


Other Outcome Measures:
  • Efficacy of MMR vaccine in pediatric SOT recipients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Protection against vaccine-preventable diseases will be assessed in pediatric SOT recipients


Estimated Enrollment: 90
Study Start Date: April 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MMR vaccination
MMR vaccine to seronegative pediatric SOT recipients
Biological: MMR vaccination
Unprotected children will be vaccinated with two MMR vaccines

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

Ages Eligible for Study:   12 Months to 20 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770119

Locations
Switzerland
Children's Hospital of Geneva Recruiting
Geneva, GE, Switzerland, 1211
Contact: Klara M Posfay-Barbe, MD, MS    +41223725462    Klara.PosfayBarbe@hcuge.ch   
Contact: Charlotte Verolet, MD    +41223725481    Charlotte.Verolet@hcuge.ch   
Principal Investigator: Klara M Posfay-Barbe, MD, MS         
Sponsors and Collaborators
Klara M. Pósfay Barbe
University Hospital, Geneva
Investigators
Principal Investigator: Klara M Posfay-Barbe, MD, MS University Hospitals of Geneva
  More Information

No publications provided

Responsible Party: Klara M. Pósfay Barbe, Head of Pediatric Infectious Diseases, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01770119     History of Changes
Other Study ID Numbers: MMR in pediatric OLT, 12-226 (MatPed 12-048)
Study First Received: January 15, 2013
Last Updated: June 24, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Measles
Mumps
Rubella
Pediatric
Solid-organ transplant
serology
vaccine

Additional relevant MeSH terms:
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014