View clinical trials related to Varicella Zoster Vaccine.
Filter by:Objective: To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titer against the Omicron XBB.1.5 strain. Trial design: Multicentre, open-label randomized controlled clinical trial, for a duration of at least 10 weeks with an optional extension to 18 weeks. Trial population: Kidney transplant recipients, 18 years or older, who are at least 6 months after transplantation, with a functioning kidney transplant, using MMF/MPA in combination with at least one other immunosuppressant including a calcineurin inhibitor (CNI), with at least 3 previous COVID-19 vaccinations (=basic COVID-19 immunisation). Interventions: Patients will be randomized into one of two equally sized groups, with either continuation of their current immunosuppressive regimen including MMF/MPA or replacement of MMF/MPA by everolimus during at least six weeks before until four weeks after the last vaccination. Patients will receive a repeated COVID-19 vaccination with the monovalent Omicron XBB.1.5 vaccine, 28 days thereafter they can opt to also receive two herpes zoster vaccinations with the Recombinant Zoster Vaccine (RZV) with an interval between the first and second dose of 28 days. Main trial endpoints: The neutralizing antibody titer against the Omicron XBB.1.5. strain 28 days after monovalent Omicron XBB.1.5 COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus. Secondary trial endpoints: - SARS-CoV-2 specific anti-S1 antibody level at 28 and 56 days after COVID-19 vaccination - Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination - SARS-CoV-2 specific T-cell response 28 days after COVID-19 vaccination - Varicella zoster specific T-cell response 28 days after 2nd herpes zoster vaccination - Safety in terms of incidence of acute rejection, kidney function decline, SAEs, AESIs and solicited local and systemic AEs after COVID-19 and herpes zoster vaccination
The investigators plan to study the immunogenicity of the vaccine in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.
The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.