Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients (VZVinOLTx)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2014 by University Hospital, Geneva
Sponsor:
University Hospital, Geneva
Information provided by (Responsible Party):
Klara M. Pósfay Barbe, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00492739
First received: June 22, 2007
Last updated: June 24, 2014
Last verified: June 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Liver Disease Liver Transplantation Varicella |
Biological: Vaccination with VZV vaccine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Geneva:
Primary Outcome Measures:
- Safety of VZV vaccine in OLTx recipients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Efficacy of VZV vaccine in immunosuppressed OLTx recipients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Varicella vaccine
2-3 doses of Varicella vaccine to seronegative patients
|
Biological: Vaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.
Other Name: Varilrix
|
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492739
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492739
Contacts
| Contact: Klara M Posfay-Barbe, MD, MS | +41 22 372 5462 | Klara.PosfayBarbe@hcuge.ch | |
| Contact: Valerie McLin, MD | +41 22 3723311 | Valerie.McLin@hcuge.ch |
Locations
| Switzerland | |
| Children's Hospital of Geneva (HUG) | Recruiting |
| Geneva, GE, Switzerland, 1211 | |
| Contact: Klara M Posfay-Barbe, MD, MS +41 22 372 5462 Klara.PosfayBarbe@hcuge.ch | |
| Contact: Valerie McLin, MD +41 22 372 3311 Valerie.McLin@hcuge.ch | |
| Principal Investigator: Klara M Posfay-Barbe, MD, MS | |
Sponsors and Collaborators
University Hospital, Geneva
Investigators
| Principal Investigator: | Klara M Posfay-Barbe, MD, MS | University Hospitals of Geneva |
More Information
No publications provided
| Responsible Party: | Klara M. Pósfay Barbe, Head of Pediatric Infectious Diseases, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT00492739 History of Changes |
| Other Study ID Numbers: | VZVinOLTx |
| Study First Received: | June 22, 2007 |
| Last Updated: | June 24, 2014 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Geneva:
|
Orthotopic liver transplantation Pediatric Immunosuppression Varicella vaccine B cell response |
T cell response Antibodies Varicella Chickenpox transplantation |
Additional relevant MeSH terms:
|
Chickenpox Herpes Zoster DNA Virus Infections Herpesviridae Infections Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015