Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients
Liver DiseaseImmunosuppression1 moreVaricella 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?
A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox...
ChickenpoxThe purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to 15 months of age.
Systems Biology of Zoster Vaccine
ZosterZoster Varicella2 moreThe purpose of the study is to better understand how the immune system responds to the new herpes zoster (shingles) vaccine (Shingrix®). The study will be looking at certain markers in the blood after vaccination with Shingrix®.
Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody...
VaricellaThis is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization histories, to evaluate the antibody level of varicella-zoster virus in healthy people aged 0-59 years in Zhejiang Province.
PREPARE-iVAC Trial
COVID-19 VaccinesVaricella Zoster Vaccine2 moreObjective: 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 BA.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 bivalent (original-BA.4/5) 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 BA.5 strain 28 days after bivalent (original-BA.4/5) 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
A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine...
Measles; Mumps; Rubella; ChickenpoxThe main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.
Evaluate the Safety and Immunogenicity After MG1111 as 2nd Vaccination in 4 ~ 6 Year Old Healthy...
VaricellaPrimary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination
A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella...
VaricellaThe goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
The Influence of Trained Immunity in COVID-19 Vaccinated Individuals
Zoster VaricellaVaccination; InfectionThe concept of trained immunity defines the long-term functional reprogramming of innate immune cells, which is evoked by exogenous or endogenous insults and leads to an altered response towards a second challenge after return to a non-activated state and is characterized by several markers, such as specific cytokines, activation markers of innate immune cells and epigenetic modifications, e.g. H3K4me3. Vaccinations have been shown to induce trained immunity and to have heterologous effects on other infections or vaccinations. A recent article showed, that individuals who had received recombinant adjuvanted zoster vaccine (RZV) before the pandemic had a 16% lower risk of COVID-19 diagnosis and a 32% lower risk of hospitalization suggesting a protective heterologous effect of RVZ on COVID19 infections. So far, the mechanisms behind these add-on benefits of RZV vaccination are on the hypothetical level and need further experimental evidence. Therefore, we aim to investigate the specific humoral and cellular immune response towards COVID-19 vaccine in healthy individuals who were exposed to RZV 1 to 12 months before COVID-19 vaccination compared to individuals who did not receive RZV before. Particular emphasis is layed on COVID-19 vaccine non-responders and individuals with breakthrough infections indicating lower vaccine efficacy compared to those who had no breakthrough infection. The primary objective is the cytokine profile of spike protein-stimulated T, NK and NKT cells. Spike protein stimulated T, NK and NKT cells are characterized by cell surface markers, transcription factor expression, chemokine receptor expression, activation and proliferation markers and by their lineage-specific cytokine pattern. CD14+ monocytes are magnetically isolated and further characterized by cell-culture experiments imitating a training and resting period after stimulation. Epigenetic modifications by methylation of CpG regions are assessed at promoter, enhancer and regulatory gene regions of immune cell characteristic transcription factors by bisulfite conversion and pyrosequencing. Chromatin immunoprecipitation and ChIP-seq will be performed for analysis H3K4me3 associated with trained immunity. Humoral and cellular reactivity to spike protein is analyzed by adapted ELISA and neutralisation assays and by ELISpot and flow cytometry, respectively, and correlated. From our findings we expect to learn about the role of previous RZV on immunogenicity and efficacy of COVID-19 vaccination and whether mechanisms of trained immunity play a role for better responses towards COVID-19 vaccination.
Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years...
VaricellaThis a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity of a two doses vaccination of investigational vaccine with 0,28 day, 0,42 day and 0,56 day immunization schedule in population aged ≥13 years old.