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
  Purpose

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 Intervention Phase
Liver Disease
Liver Transplantation
Varicella
Biological: Vaccination with VZV vaccine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Safety of VZV vaccine in OLTx recipients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of VZV vaccine in immunosuppressed OLTx recipients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: June 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varicella vaccine
2-3 doses of Varicella vaccine to seronegative patients
Biological: Vaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.
Other Name: Varilrix

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492739

Contacts
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

Locations
Switzerland
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         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Klara M Posfay-Barbe, MD, MS University Hospitals of Geneva
  More Information

No publications provided

Responsible Party: Klara M. Pósfay Barbe, Head of Pediatric Infectious Diseases, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00492739     History of Changes
Other Study ID Numbers: VZVinOLTx
Study First Received: June 22, 2007
Last Updated: June 24, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Orthotopic liver transplantation
Pediatric
Immunosuppression
Varicella vaccine
B cell response
T cell response
Antibodies
Varicella
Chickenpox
transplantation

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Liver Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 26, 2014