VZVinOLTx: Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients

Sponsor

University Hospital, Geneva (Other)

Overall Status

Recruiting

CT.gov ID

NCT00492739

Collaborator

(none)

Enrollment

Location

Arm

222

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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

Anticipated Enrollment :

80 participants

Allocation:

N/A

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 :

Jun 1, 2007

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Varilrix

Arm

Intervention/Treatment

Other: 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 Names:

Varilrix

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy of VZV vaccine in immunosuppressed OLTx recipients [3 years]
Protection from disease monitored

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.