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

This study is currently recruiting participants.
Verified December 2016 by Klara M. Pósfay Barbe, University Hospital, Geneva
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492739
First Posted: June 27, 2007
Last Update Posted: December 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Klara M. Pósfay Barbe, University Hospital, Geneva
June 22, 2007
June 27, 2007
December 30, 2016
June 2007
April 2017   (Final data collection date for primary outcome measure)
Safety of VZV vaccine in OLTx recipients [ Time Frame: 2 years ]
Same as current
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 ]
Same as current
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?
VZV vaccine given to pediatric liver transplant recipients at least one year after transplantation if tehy fulfill inclusion criteria and give informed consent.
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Disease
  • Immunosuppression
  • Varicella
Biological: Vaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.
Other Name: Varilrix
Varicella vaccine
2-3 doses of Varicella vaccine to seronegative patients two months apart
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 2017
April 2017   (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.
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
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
Not Provided
Plan to Share IPD: Undecided
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
December 2016

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