Immunosuppression, Liver Disease, Varicella
Conditions
Keywords
Orthotopic liver transplantation, Pediatric, Immunosuppression, Varicella vaccine, B cell response, T cell response, Antibodies, Varicella, Chickenpox, transplantation
Brief summary
Varicella is a vaccine-preventable disease, which can be severe in immunosuppressed children. Currently, the (live) vaccine is not recommended in pediatric orthotopic liver transplant recipients. Furthermore, protection due to naturally acquired immunity to VZV or post-immunization isn't well described in this population.The questions asked are: * What is the influence of the immunosuppression required after orthotopic liver transplantation (OLT) on the maintenance of VZV-specific immunity elicited by wild-type varicella infection before OLT transplantation? * What is the influence of the immunosuppression required after OLT on VZV-specific immunity elicited by varicella immunization before OLT transplantation? * What is the influence of the residual immunosuppression at ≥ 12 months after OLT transplantation on the induction of VZV-specific B and T cell responses elicited by VZV vaccination after OLT transplantation? * What is the influence of the residual immunosuppression at ≥ 12 months after OLT transplantation on the persistence / waning of B and T cell responses elicited by VZV vaccination?
Detailed description
VZV vaccine given to pediatric liver transplant recipients at least one year after transplantation if tehy fulfill inclusion criteria and give informed consent.
Interventions
BIOLOGICALVaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.
Sponsors
University Hospital, Geneva
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children either awaiting or recipients of a liver transplantation followed at the Children's Hospital of Geneva, Switzerland * If vaccination offered: \> 12 months of age
Exclusion criteria
* Known wild type varicella exposure within four weeks of the initial vaccine * Immunoglobulins administered within the 5 months preceding the receipt of varicella vaccine. * Antiviral agents administered during the preceding 4 weeks * Febrile illness (\>38.5°) in the 72 hours before vaccine administration * Chronic aspirin therapy * Any other live vaccinations within four weeks of receipt of varicella vaccine * Female patients in childbearing age will have a pregnancy test at enrollment, and at the time of the second vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of VZV vaccine in OLTx recipients | 2 years | Antibody response measured after vacination with long-term f/u |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of VZV vaccine in immunosuppressed OLTx recipients | 3 years | Protection from disease monitored |
Countries
Switzerland
Contacts
Primary ContactKlara M Posfay-Barbe, MD, MS
Backup ContactValerie McLin, MD
Outcome results
None listed