Liver DiseasePhase 2/3VZVinOLTxNCT00492739
Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients
A Phase 2/3 study testing Vaccination with VZV vaccine in people with Liver Disease and Immunosuppression, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Liver Disease, Immunosuppression, Varicella
- What is being tested?
- Vaccination with VZV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2007to Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Children's Hospital of Geneva (HUG)
Geneva, Canton of Geneva, 1211
Klara M Posfay-Barbe, MD, MS, +41 22 372 5462, Klara.PosfayBarbe@hcuge.ch
Valerie McLin, MD, +41 22 372 3311, Valerie.McLin@hcuge.ch
About this study
Official title: Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland
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.
- Conditions
- Liver Disease, Immunosuppression, Varicella
- Being tested
- Vaccination with VZV vaccine
- Keywords
- Orthotopic liver transplantation, Pediatric, Immunosuppression, Varicella vaccine, B cell response, T cell response, Antibodies, Varicella, Chickenpox, transplantation
- Medical subject headings
- Liver Diseases, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with VZV vaccineBiological
Also called Varilrix
Varicella vaccination 2 doses 2 months apart.
| Study group | Role | What they receive |
|---|---|---|
| Varicella vaccine | Other | 2-3 doses of Varicella vaccine to seronegative patients two months apart Receives: Biological: Vaccination with VZV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of VZV vaccine in OLTx recipients
Antibody response measured after vacination with long-term f/u
Measured: 2 years
Secondary outcomes (1)
Efficacy of VZV vaccine in immunosuppressed OLTx recipients
Protection from disease monitored
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klara M. Pósfay Barbe, University Hospital, Geneva
- Investigators
- Klara M Posfay-Barbe, MD, MS, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492739
- Sponsor's protocol ID
- VZVinOLTx
- Acronym
- VZVinOLTx
- Status last verified
- Sep 2020
- First submitted
- 22 Jun 2007
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 31497926Verolet 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 31335765Posfay-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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland
- ClinicalTrials.gov ID
- NCT00492739
- Acronym / sponsor ID
- VZVinOLTx / VZVinOLTx
- Conditions
- Liver Disease, Immunosuppression, Varicella
- Keywords
- Orthotopic liver transplantation, Pediatric, Immunosuppression, Varicella vaccine, B cell response, T cell response, Antibodies, Varicella
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
VZV vaccine given to pediatric liver transplant recipients at least one year after transplantation if tehy fulfill inclusion criteria and give informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varicella vaccine | Other | Biological: Vaccination with VZV vaccine2-3 doses of Varicella vaccine to seronegative patients two months apart |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination with VZV vaccineAlso: VarilrixVaricella vaccination 2 doses 2 months apart. | Biological | Varicella vaccine |
Primary outcome
Safety of VZV vaccine in OLTx recipients
Time frame: 2 years
Antibody response measured after vacination with long-term f/u
1 secondary outcome
Efficacy of VZV vaccine in immunosuppressed OLTx recipients
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Background: PubMed 31497926Suresh 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.
- Background: PubMed 31335765Verolet 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.
- Background: PubMed 22994936Posfay-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klara M Posfay-Barbe, MD, MS principal investigator
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vaccination with VZV vaccine in people with Liver Disease and Immunosuppression, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klara M Posfay-Barbe, MD, MS (+41 22 372 5462, Klara.PosfayBarbe@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of VZV vaccine in OLTx recipients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00492739, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.