Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients

NCT00492739 | Unknown Phase 2 DMC

• 1 other identifier: VZVinOLTx
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Liver Disease; Immunosuppression; Varicella

Keywords

Orthotopic liver transplantation; Pediatric; Immunosuppression; Varicella vaccine; B cell response; T cell response; Antibodies; Varicella; Chickenpox; transplantation

Outcome Measures

Primary Outcomes (1)

• Safety of VZV vaccine in OLTx recipients

  Antibody response measured after vacination with long-term f/u

  2 years

Secondary Outcomes (1)

• Efficacy of VZV vaccine in immunosuppressed OLTx recipients

  3 years

Study Arms (1)

Varicella vaccine

OTHER

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

Biological: Vaccination with VZV vaccine

Interventions

Vaccination with VZV vaccine BIOLOGICAL

Varicella vaccination 2 doses 2 months apart.

Also known as: Varilrix

Varicella vaccine

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Children's Hospital of Geneva (HUG)

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related Publications (3)

• 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.

  PMID: 31497926 BACKGROUND

• 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.

  PMID: 31335765 BACKGROUND

• 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.

  PMID: 22994936 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; Chickenpox

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Digestive System Diseases; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Klara M Posfay-Barbe, MD, MS

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klara M Posfay-Barbe, MD, MS

CONTACT

+41 22 372 5462; Klara.PosfayBarbe@hcuge.ch

Valerie McLin, MD

CONTACT

+41 22 3723311; Valerie.McLin@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Infectious Diseases

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2025
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)