Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients (VZVinOLTx)
September 16, 2020 updated by: Klara M. Pósfay Barbe, University Hospital, Geneva
Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland
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?
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Klara M Posfay-Barbe, MD, MS
- Phone Number: +41 22 372 5462
- Email: Klara.PosfayBarbe@hcuge.ch
Study Contact Backup
- Name: Valerie McLin, MD
- Phone Number: +41 22 3723311
- Email: Valerie.McLin@hcuge.ch
Study Locations
-
-
GE
-
Geneva, GE, Switzerland, 1211
- Recruiting
- Children's Hospital of Geneva (HUG)
-
Contact:
- Klara M Posfay-Barbe, MD, MS
- Phone Number: +41 22 372 5462
- Email: Klara.PosfayBarbe@hcuge.ch
-
Contact:
- Valerie McLin, MD
- Phone Number: +41 22 372 3311
- Email: Valerie.McLin@hcuge.ch
-
Principal Investigator:
- Klara M Posfay-Barbe, MD, MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Varicella vaccine
2-3 doses of Varicella vaccine to seronegative patients two months apart
|
Varicella vaccination 2 doses 2 months apart.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety of VZV vaccine in OLTx recipients
Time Frame: 2 years
|
Antibody response measured after vacination with long-term f/u
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of VZV vaccine in immunosuppressed OLTx recipients
Time Frame: 3 years
|
Protection from disease monitored
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Klara M Posfay-Barbe, MD, MS, University Hospitals of Geneva
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Anticipated)
April 1, 2022
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
June 22, 2007
First Submitted That Met QC Criteria
June 26, 2007
First Posted (Estimate)
June 27, 2007
Study Record Updates
Last Update Posted (Actual)
September 18, 2020
Last Update Submitted That Met QC Criteria
September 16, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VZVinOLTx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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