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RecruitingNCT00492739VZVinOLTxUpdated Sep 18, 2020

Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients

A Phase 2/3 interventional study of Vaccination with VZV vaccine in Liver Disease, Immunosuppression and Varicella, sponsored by University Hospital, Geneva. Recruiting at 1 site in Switzerland. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-09-18.

Sponsored by University Hospital, Geneva · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2022, 4 years 7 months ago, but the record still lists the study as recruiting.
Phase
Phase 2/3
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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?
Read the detailed description

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

02

Conditions studied

  • Liver Disease
  • Immunosuppression
  • Varicella

Keywords

  • Orthotopic liver transplantation
  • Pediatric
  • Immunosuppression
  • Varicella vaccine
  • B cell response
  • T cell response
  • Antibodies
  • Varicella
  • Chickenpox
  • transplantation
03

In context

Liver Diseases

824 studies on the registry are indexed under Liver Diseases; 152 are open to participants now.

This study's planned enrollment of 80 is above the median of 52 across 521 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.

Browse University Hospital, Geneva studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    Varicella vaccine

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

    Biological: Vaccination with VZV vaccine

Interventions

  • BiologicalVaccination with VZV vaccine

    Drug page: Chickenpox Vaccine

    Varicella vaccination 2 doses 2 months apart.

    Also known as: Varilrix

06

What researchers measure

Primary outcomes

  1. Safety of VZV vaccine in OLTx recipients

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

    Time frame: 2 years

Secondary outcomes

  1. Efficacy of VZV vaccine in immunosuppressed OLTx recipients

    Protection from disease monitored

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 31497926 ↗
  • 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. PubMed 31335765 ↗
  • 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. PubMed 22994936 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2007, a primary completion of Apr 2022 and a completion of Dec 2025. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2007
First posted
Jun 27, 2007
Start
Jun 2007
Primary completionEst.
Apr 2022
CompletionEst.
Dec 2025
Last update
Sep 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00492739
Lead sponsor
University Hospital, Geneva
Responsible party
Klara M. Pósfay Barbe (Head of Pediatric Infectious Diseases, University Hospital, Geneva) — Principal investigator
First posted
Jun 27, 2007
Start date
Jun 2007
Primary completion
Apr 2022 (estimated)
Completion
Dec 2025 (estimated)
Last update
Sep 18, 2020

Study contacts

Klara M Posfay-Barbe, MD, MS
Contact
Klara.PosfayBarbe@hcuge.ch
+41 22 372 5462
Valerie McLin, MD
Contact
Valerie.McLin@hcuge.ch
+41 22 3723311
Klara M Posfay-Barbe, MD, MS
principal investigator · University Hospitals of Geneva

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Chickenpox Vaccine

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