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Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients (VZVinOLTx)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Klara M. Pósfay Barbe, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00492739
First received: June 22, 2007
Last updated: June 24, 2014
Last verified: June 2014

June 22, 2007
June 24, 2014
June 2007
April 2015   (final data collection date for primary outcome measure)
Safety of VZV vaccine in OLTx recipients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Safety of VZV vaccine in OLTx recipients [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00492739 on ClinicalTrials.gov Archive Site
Efficacy of VZV vaccine in immunosuppressed OLTx recipients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Efficacy of VZV vaccine in immunosuppressed OLTx recipients [ Time Frame: 3 years ]
Not Provided
Not Provided
 
Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients
Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland

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?
Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Disease
  • Liver Transplantation
  • Varicella
Biological: Vaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.
Other Name: Varilrix
Experimental: Varicella vaccine
2-3 doses of Varicella vaccine to seronegative patients
Intervention: Biological: Vaccination with VZV vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
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
Switzerland
 
NCT00492739
VZVinOLTx
Yes
Klara M. Pósfay Barbe, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Klara M Posfay-Barbe, MD, MS University Hospitals of Geneva
University Hospital, Geneva
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP