Vaccination against chickenpox in children who have had a liver transplant
Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland
This study tests how well the chickenpox vaccine works in children who have had a liver transplant and if their immune system can handle it safely.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva, GE) |
| Trial ID | NCT00492739 on ClinicalTrials.gov |
What this trial studies
This study investigates the immune response to the varicella vaccine in pediatric patients who have undergone orthotopic liver transplantation. It aims to understand how immunosuppression affects the maintenance of immunity to varicella-zoster virus (VZV) both before and after transplantation. The study will administer the varicella vaccine to eligible children at least one year post-transplant and assess their B and T cell responses. The goal is to determine the safety and efficacy of the vaccine in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include children over 12 months of age who are either awaiting or have received a liver transplant.
Not a fit: Patients with recent exposure to wild-type varicella or those who have received immunoglobulins or antiviral agents shortly before vaccination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe vaccination option against varicella for immunosuppressed pediatric liver transplant recipients.
How similar studies have performed: While the approach of vaccinating immunosuppressed individuals is being explored, this specific study on pediatric liver transplant recipients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Geneva, GE
- Children's Hospital of Geneva (HUG) — Geneva, Ge, Switzerland (Recruiting)
Study contacts
- Principal investigator: Klara M Posfay-Barbe, MD, MS — University Hospitals of Geneva
- Study coordinator: Klara M Posfay-Barbe, MD, MS
- Email: Klara.PosfayBarbe@hcuge.ch
- Phone: +41 22 372 5462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.