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Varicella Zoster Virus Infection clinical trials

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NCT ID: NCT05664152 Not yet recruiting - Clinical trials for Varicella Zoster Virus Infection

An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years

Start date: February 2023
Phase: N/A
Study type: Interventional

The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are: - Safety of BARYCELA inj. (Live attenuated varicella vaccine for injection) - Immunogenicity of BARYCELA inj. (Live attenuated varicella vaccine for injection) Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).

NCT ID: NCT05604911 Recruiting - Clinical trials for Kidney Transplant; Complications

Herpes Virus Infections in Kidney Transplant Patients

HINT
Start date: January 1, 2023
Phase:
Study type: Observational

Kidney transplant recipients are at increased risk of infections, including Varicella-zoster virus (VZV) infections. Vaccination against VZV is routinely offered to all kidney transplant recipients and candidates in Denmark. In this exploratory observational study, the VZV specific immune response in kidney transplant candidates and recipients will be characterized at different time points in relation to transplantation, vaccination and infections. More knowledge on the immune reaction to transplantation, VZV vaccination and VZV infections may provide improved strategies for prevention and treatment of VZV infections in kidney transplant candidates and recipients.

NCT ID: NCT05532540 Recruiting - Clinical trials for Cytomegalovirus Infections

Herpesvirus Immunology in Solid Organ Transplant Recipients - Liver Transplant Study

HISTORY
Start date: January 1, 2023
Phase:
Study type: Observational

Liver transplantation is the only curative treatment of end-stage liver disease, and every year, around 60 patients undergo liver transplantation in Denmark. Immunosuppressive therapy is necessary to avoid rejection of the transplanted organ. Over 90% of adults have been infected with at least one herpesvirus, and it is characteristic for herpesviruses that after a first-time infection, the virus remains dormant in the body and may reactivate, particularly if the host is immunosuppressed. An effective immune response against reactivation depends highly on T cells, but T cells are suppressed by immunosuppressive drugs given to organ transplant recipients. Infections caused by herpesviruses are therefore very common in organ transplant recipients, and particularly two herpesviruses, cytomegalovirus (CMV) and varicella-zoster virus (VZV) pose challenges after transplantation. CMV causes significant morbidity in transplant recipients, contributes to increased mortality and may contribute to loss of the transplanted organ. CMV infections occur in around 40% of liver transplant recipients within a year of transplantation. VZV causes chickenpox at first-time infection and shingles at reactivation. VZV is the second-most common infection in transplant recipients and occurs in around 9% of liver transplant recipients each year. Organ transplant recipients are at higher risk for disseminated disease with complications compared to immunocompetent persons. A limited number of drugs exist that reduce the risk of and treat CMV infection, but they may cause significant adverse events, and drug resistance is emerging. To avoid CMV infection, some liver transplant recipients receive prophylactic therapy, but due to toxicity, new treatment modalities are warranted. This requires knowledge about herpesvirus specific T cell function in liver transplant recipients, which currently is limited. The aim of this study is to provide an in-depth description of the protective immune response and immunological risk factors for CMV and VZV infections in liver transplant recipients and to identify patients at high risk in order to provide a platform for future treatment modalities against CMV and VZV infections in liver transplant recipients.

NCT ID: NCT05198570 Recruiting - Oncology Clinical Trials

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Start date: September 15, 2021
Phase:
Study type: Observational

- Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality. - Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals. - Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection. - Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection. - Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children. - Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.

NCT ID: NCT04403139 Recruiting - Clinical trials for Varicella Zoster Virus Infection

VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination

Start date: April 27, 2022
Phase: Phase 4
Study type: Interventional

To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells

NCT ID: NCT04081480 Terminated - Clinical trials for Varicella Zoster Virus Infection

Pharmacokinetics of Valacyclovir Oral Solution in Children

VALID2
Start date: December 10, 2019
Phase: N/A
Study type: Interventional

Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing. The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir. Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.

NCT ID: NCT03509701 Recruiting - Clinical trials for Reversible Cerebral Vasoconstriction Syndrome

Reversible Cerebral Vasoconstriction Syndrome and Varicella Zoster Virus

RCVS&VZV
Start date: May 1, 2018
Phase:
Study type: Observational

Among patients with thunderclap headache who were admitted to the four participating hospitals, who has diffuse segmental vasoconstriction on CT angiography or MR angiography will be eligible for the study. Participants who meet the definition of RCVS will be enrolled as the case-patients and others will be enrolled as control-patients. The RCVS group will be defined when two or more neurologists agree by the clinical features and angiographic findings. The result of tests for varicella zoster virus titer will not be opened to neurologists until the end of the study. For case and control patients, tests for varicella zoster virus infection are (1) Pre-existing virological markers (ex. VZV-IgG, IgM, and VZV PCR in CSF or Skin lesion if present) (2) VZV-specific cell mediated immune response (CMI) at the time of admission and one month later (3) VZV in blood measured by quantitative test of viral load with real-time PCR and digital PCR for latent viral load (4) Quantitative test of viral load with real-time PCR in saliva at time of admission and one month later. Reactivation or infection of VZV of patients with RCVS and controls will be compared.

NCT ID: NCT02715752 Completed - Clinical trials for Cytomegalovirus Infections

A Retrospective Chart Review Study of Gene-Eden-VIR/Novirin

Start date: January 2016
Phase: N/A
Study type: Observational

This study measured the changes in health-related complaints by analyzing charts of individuals, who are infected with a latent virus, who have used Gene-Eden-VIR/Novirin.

NCT ID: NCT02329457 Completed - Clinical trials for Varicella Zoster Infection

VZV Vaccine for Hematopoietic Stem Cell Transplantation

VZIDST
Start date: December 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Hematopoietic stem cell transplantation (HSCT) is well-established therapy for patients with malignant hematological diseases. Varicella zoster virus (VZV) reactivation, clinically manifested as herpes zoster (HZ), is a major complication that affects up to 50% of patients. Most patients will require hospitalization. Despite treatment with high dose acyclovir, patients may develop severe complications including the disabling postherpetic neuralgia, corneal ulceration, viral dissemination and secondary bacterial infection. The median onset of infection is the fifth month following transplantation, with 91% of cases occurring within the first year. Direct vaccination of transplants recipients with subcutaneous live-attenuated VZVv before transplantation and up to one year after transplantation is contraindicated. A small prospective non-randomized study has demonstrated that subcutaneous vaccination for donors before HSCT may offer some protection against VZV reactivation in the recipients. Recently, dose-sparing influenza vaccine delivered via a novel intradermal microneedle has been shown to elicit a good immunogenic response in both healthy and elderly subjects. We sought to assess the efficacy and safety of the novel intradermal live-attenuated VZVv in sibling donors undergoing HSCT.

NCT ID: NCT01689285 Completed - Clinical trials for Varicella Zoster Virus Infection

Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir

VALID-I
Start date: December 2013
Phase: Phase 1
Study type: Interventional

A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid will be measured and compared to the tablet.