Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients

NCT ID: NCT00492739

Last Updated: 2020-09-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2025-12-31

Brief Summary

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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

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VZV vaccine given to pediatric liver transplant recipients at least one year after transplantation if tehy fulfill inclusion criteria and give informed consent.

Conditions

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Liver Disease Immunosuppression Varicella

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Varicella vaccine

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

Group Type OTHER

Vaccination with VZV vaccine

Intervention Type BIOLOGICAL

Varicella vaccination 2 doses 2 months apart.

Interventions

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Vaccination with VZV vaccine

Varicella vaccination 2 doses 2 months apart.

Intervention Type BIOLOGICAL

Other Intervention Names

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Varilrix

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Klara M. Pósfay Barbe

Head of Pediatric Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Klara M Posfay-Barbe, MD, MS

Role: CONTACT

+41 22 372 5462

Valerie McLin, MD

Role: CONTACT

+41 22 3723311

Facility Contacts

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Klara M Posfay-Barbe, MD, MS

Role: primary

+41 22 372 5462

Valerie McLin, MD

Role: backup

+41 22 372 3311

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.

Reference Type BACKGROUND
PMID: 31497926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31335765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22994936 (View on PubMed)

Other Identifiers

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VZVinOLTx

Identifier Type: -

Identifier Source: org_study_id

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