Immunosuppression Clinical Trial
— VZVinOLTxOfficial 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?
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Children's Hospital of Geneva (HUG) | Geneva | GE |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05060991 -
Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
|
Phase 4 | |
Completed |
NCT02833805 -
NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia
|
Phase 2 | |
Completed |
NCT01252537 -
Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia
|
N/A | |
Completed |
NCT00621699 -
Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01678937 -
Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents
|
N/A | |
Completed |
NCT00788021 -
Protective Immunity Project 01
|
N/A | |
Active, not recruiting |
NCT00166842 -
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
|
Phase 4 | |
Recruiting |
NCT05616130 -
Pathological Myeloid Activation After Sepsis and Trauma
|
||
Completed |
NCT03117192 -
Zinc Supplementation on Cellular Immunity in Thalassemia Major
|
Phase 4 | |
Recruiting |
NCT01568697 -
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
|
||
Not yet recruiting |
NCT06024226 -
Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC
|
||
Not yet recruiting |
NCT04961229 -
Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response
|
Phase 4 | |
Completed |
NCT03139565 -
High Dose vs. Standard Influenza Vaccine in Adult SOT
|
Phase 3 | |
Completed |
NCT02547753 -
Dental Extractions Among Renal Transplant Recipients
|
||
Completed |
NCT01702207 -
Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk
|
Phase 4 | |
Completed |
NCT00626808 -
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
|
Phase 4 | |
Completed |
NCT00419575 -
Renal Transplantation With Immune Monitoring
|
N/A | |
Completed |
NCT00783380 -
Influenza Vaccination in Immunocompromized Patients
|
Phase 4 | |
Completed |
NCT04835948 -
Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
|
||
Recruiting |
NCT05043870 -
Combined Immunosuppression for Pediatric Crohn's Disease
|
Phase 4 |