Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients
NCT ID: NCT00492739
Last Updated: 2020-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2007-06-30
2025-12-31
Brief Summary
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* 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?
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Varicella vaccine
2-3 doses of Varicella vaccine to seronegative patients two months apart
Vaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.
Interventions
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Vaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If vaccination offered: \> 12 months of age
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Klara M. Pósfay Barbe
Head of Pediatric Infectious Diseases
Principal Investigators
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Klara M Posfay-Barbe, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University Hospitals of Geneva
Locations
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Children's Hospital of Geneva (HUG)
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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VZVinOLTx
Identifier Type: -
Identifier Source: org_study_id
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