Clinical trial NCT00492739: Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients
Official title: Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Liver Disease
Immunosuppression
Varicella
Keywords: Orthotopic liver transplantation
Pediatric
Immunosuppression
Varicella vaccine
B cell response
T cell response
Antibodies
Varicella
Chickenpox
transplantation
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of VZV vaccine in OLTx recipients
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy of VZV vaccine in immunosuppressed OLTx recipients
timeFrame: 3 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Children's Hospital of Geneva (HUG)
state: GE
Study officials:
affiliation: University Hospitals of Geneva
name: Klara M Posfay-Barbe, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Verolet CM, Pittet LF, Wildhaber BE, McLin VA, Rodriguez M, Grillet S, Siegrist CA, Posfay-Barbe KM. Long-term Seroprotection of Varicella-zoster Immunization in Pediatric Liver Transplant Recipients. Transplantation. 2019 Nov;103(11):e355-e364. doi: 10.1097/TP.0000000000002866.
citation: Posfay-Barbe KM, Pittet LF, Sottas C, Grillet S, Wildhaber BE, Rodriguez M, Kaiser L, Belli DC, McLin VA, Siegrist CA. Varicella-zoster immunization in pediatric liver transplant recipients: safe and immunogenic. Am J Transplant. 2012 Nov;12(11):2974-85. doi: 10.1111/j.1600-6143.2012.04273.x. Epub 2012 Sep 20.