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

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.
ClinicalTrials.gov Identifier: NCT00492739
Recruitment Status : Recruiting
First Posted : June 27, 2007
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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?

Condition or disease Intervention/treatment Phase
Liver Disease Immunosuppression Varicella Biological: Vaccination with VZV vaccine Phase 2 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2007
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Varicella vaccine
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


Outcome Measures

Primary Outcome Measures :
  1. Safety of VZV vaccine in OLTx recipients [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Efficacy of VZV vaccine in immunosuppressed OLTx recipients [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

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
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Liver Diseases
Chickenpox
Herpes Zoster
Digestive System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs