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

Primary Purpose

Liver Disease, Immunosuppression, Varicella

Status
Recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Vaccination with VZV vaccine
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring Orthotopic liver transplantation, Pediatric, Immunosuppression, Varicella vaccine, B cell response, T cell response, Antibodies, Varicella, Chickenpox, transplantation

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Children's Hospital of Geneva (HUG)Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Varicella vaccine

Arm Description

2-3 doses of Varicella vaccine to seronegative patients two months apart

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy of VZV vaccine in immunosuppressed OLTx recipients
Protection from disease monitored

Full Information

First Posted
June 22, 2007
Last Updated
September 16, 2020
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT00492739
Brief Title
Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients
Acronym
VZVinOLTx
Official Title
Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
Yes

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease, Immunosuppression, Varicella
Keywords
Orthotopic liver transplantation, Pediatric, Immunosuppression, Varicella vaccine, B cell response, T cell response, Antibodies, Varicella, Chickenpox, transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Varicella vaccine
Arm Type
Other
Arm Description
2-3 doses of Varicella vaccine to seronegative patients two months apart
Intervention Type
Biological
Intervention Name(s)
Vaccination with VZV vaccine
Other Intervention Name(s)
Varilrix
Intervention Description
Varicella vaccination 2 doses 2 months apart.
Primary Outcome Measure Information:
Title
Safety of VZV vaccine in OLTx recipients
Description
Antibody response measured after vacination with long-term f/u
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Efficacy of VZV vaccine in immunosuppressed OLTx recipients
Description
Protection from disease monitored
Time Frame
3 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klara M Posfay-Barbe, MD, MS
Phone
+41 22 372 5462
Email
Klara.PosfayBarbe@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie McLin, MD
Phone
+41 22 3723311
Email
Valerie.McLin@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klara M Posfay-Barbe, MD, MS
Organizational Affiliation
University Hospitals of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Geneva (HUG)
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klara M Posfay-Barbe, MD, MS
Phone
+41 22 372 5462
Email
Klara.PosfayBarbe@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Valerie McLin, MD
Phone
+41 22 372 3311
Email
Valerie.McLin@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Klara M Posfay-Barbe, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31497926
Citation
Suresh S, Upton J, Green M, Pham-Huy A, Posfay-Barbe KM, Michaels MG, Top KA, Avitzur Y, Burton C, Chong PP, Danziger-Isakov L, Dipchand AI, Hebert D, Kumar D, Morris SK, Nalli N, Ng VL, Nicholas SK, Robinson JL, Solomon M, Tapiero B, Verma A, Walter JE, Allen UD. Live vaccines after pediatric solid organ transplant: Proceedings of a consensus meeting, 2018. Pediatr Transplant. 2019 Nov;23(7):e13571. doi: 10.1111/petr.13571. Epub 2019 Sep 9.
Results Reference
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PubMed Identifier
31335765
Citation
Verolet CM, Pittet LF, Wildhaber BE, McLin VA, Rodriguez M, Grillet S, Siegrist CA, Posfay-Barbe KM. Long-term Seroprotection of Varicella-zoster Immunization in Pediatric Liver Transplant Recipients. Transplantation. 2019 Nov;103(11):e355-e364. doi: 10.1097/TP.0000000000002866.
Results Reference
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PubMed Identifier
22994936
Citation
Posfay-Barbe KM, Pittet LF, Sottas C, Grillet S, Wildhaber BE, Rodriguez M, Kaiser L, Belli DC, McLin VA, Siegrist CA. Varicella-zoster immunization in pediatric liver transplant recipients: safe and immunogenic. Am J Transplant. 2012 Nov;12(11):2974-85. doi: 10.1111/j.1600-6143.2012.04273.x. Epub 2012 Sep 20.
Results Reference
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Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients

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