Trials / Unknown
UnknownNCT01770119
Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients
Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Klara M. Pósfay Barbe · Academic / Other
- Sex
- All
- Age
- 12 Months – 20 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MMR vaccination | Unprotected children will be vaccinated with two MMR vaccines |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2022-04-01
- Completion
- 2025-10-01
- First posted
- 2013-01-17
- Last updated
- 2020-09-18
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01770119. Inclusion in this directory is not an endorsement.