Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients (VZVinOLTx)
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|ClinicalTrials.gov Identifier: NCT00492739|
Recruitment Status : Recruiting
First Posted : June 27, 2007
Last Update Posted : December 30, 2016
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?
|Condition or disease||Intervention/treatment||Phase|
|Liver Disease Immunosuppression Varicella||Biological: Vaccination with VZV vaccine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||December 2017|
2-3 doses of Varicella vaccine to seronegative patients two months apart
Biological: Vaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.
Other Name: Varilrix
- Safety of VZV vaccine in OLTx recipients [ Time Frame: 2 years ]
- Efficacy of VZV vaccine in immunosuppressed OLTx recipients [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492739
|Contact: Klara M Posfay-Barbe, MD, MS||+41 22 372 5462||Klara.PosfayBarbe@hcuge.ch|
|Contact: Valerie McLin, MD||+41 22 3723311||Valerie.McLin@hcuge.ch|
|Children's Hospital of Geneva (HUG)||Recruiting|
|Geneva, GE, Switzerland, 1211|
|Contact: Klara M Posfay-Barbe, MD, MS +41 22 372 5462 Klara.PosfayBarbe@hcuge.ch|
|Contact: Valerie McLin, MD +41 22 372 3311 Valerie.McLin@hcuge.ch|
|Principal Investigator: Klara M Posfay-Barbe, MD, MS|
|Principal Investigator:||Klara M Posfay-Barbe, MD, MS||University Hospitals of Geneva|