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

This study is currently recruiting participants.

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Contacts and Locations

Verified December 2016 by Klara M. Pósfay Barbe, 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: December 29, 2016

Last verified: December 2016

History of Changes

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 Immunosuppression Varicella	Biological: Vaccination with VZV vaccine	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Liver Transplantation Shingles

U.S. FDA Resources

Further study details as provided by Klara M. Pósfay Barbe, University Hospital, Geneva:

Primary Outcome Measures:

Safety of VZV vaccine in OLTx recipients [ Time Frame: 2 years ]

Secondary Outcome Measures:

Efficacy of VZV vaccine in immunosuppressed OLTx recipients [ Time Frame: 3 years ]


Estimated Enrollment:	80
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	April 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

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


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:	December 29, 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

ClinicalTrials.gov processed this record on August 18, 2017

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