Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients

Phase 2

Recruiting

• Conditions: Liver Disease; Varicella; Immunosuppression
• Interventions: Biological: Vaccination with VZV vaccine

• Registration Number: NCT00492739
• Lead Sponsor: University Hospital, Geneva

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?

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18
• Primary Completion: 2022-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Varicella vaccine	Vaccination with VZV vaccine	2-3 doses of Varicella vaccine to seronegative patients two months apart

Primary Outcome Measures

Name	Time	Method
Safety of VZV vaccine in OLTx recipients	2 years	Antibody response measured after vacination with long-term f/u

Secondary Outcome Measures

Name	Time	Method
Efficacy of VZV vaccine in immunosuppressed OLTx recipients	3 years	Protection from disease monitored

Trial Locations

Locations (1)

Children's Hospital of Geneva (HUG); 🇨🇭 Geneva, GE, Switzerland