Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients

Immunosuppression Clinical Trial

— VZVinOLTx  

Official title:

Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00492739
• Other study ID #: VZVinOLTx
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 2007
• Est. completion date: December 2025

Study information

• Verified date: September 2020
• Source: University Hospital, Geneva
• Contact: Klara M Posfay-Barbe, MD, MS
• Phone: +41 22 372 5462
• Email: Klara.PosfayBarbe[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Immunosuppression
• Liver Disease
• Liver Diseases
• Varicella

Intervention

Biological:
• Vaccination with VZV vaccine
Varicella vaccination 2 doses 2 months apart.

Locations

Country	Name	City	State
Switzerland	Children's Hospital of Geneva (HUG)	Geneva	GE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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, Hébert 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of VZV vaccine in OLTx recipients	Antibody response measured after vacination with long-term f/u	2 years
Secondary	Efficacy of VZV vaccine in immunosuppressed OLTx recipients	Protection from disease monitored	3 years