- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770119
Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients (MMRinOLT)
Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland
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.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
GE
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Geneva, GE, Switzerland, 1211
- Recruiting
- Children's Hospital of Geneva
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Principal Investigator:
- Klara M Posfay-Barbe, MD, MS
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Contact:
- Klara M Posfay-Barbe, MD, MS
- Phone Number: +41223725462
- Email: Klara.PosfayBarbe@hcuge.ch
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Contact:
- Natasha Loevy, MD
- Phone Number: +41223725481
- Email: Natasha.Loevy@hcuge.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MMR vaccination
MMR vaccine to seronegative pediatric SOT recipients
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Unprotected children will be vaccinated with two MMR vaccines
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serologic response to MMR vaccine in seronegative transplant recipients
Time Frame: 2 months after vaccination
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Pediatric transplant recipients will be vaccinated with MMR vaccine (previously seronegative) and their seroresponse will be measured 2 months later
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2 months after vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Persistance of seroresponse to MMR vaccine
Time Frame: 3 years
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Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients
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3 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of MMR vaccine in pediatric SOT recipients
Time Frame: 3 years
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Protection against vaccine-preventable diseases will be assessed in pediatric SOT recipients
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3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Klara M Posfay-Barbe, MD, MS, University Hospitals of Geneva
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMR in pediatric OLT
- 12-226 (MatPed 12-048) (Other Identifier: IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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