Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients (MMRinOLT)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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
- 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: | February 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | January 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 |
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| Switzerland | |
| Children's Hospital of Geneva | Not yet recruiting |
| Geneva, GE, Switzerland, 1211 | |
| Contact: Klara M Posfay-Barbe, MD, MS +41223823311 Klara.PosfayBarbe@hcuge.ch | |
| Principal Investigator: Klara M Posfay-Barbe, MD, MS | |
| 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: | January 15, 2013 |
| 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 May 16, 2013