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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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