VZV Vaccine for Hematopoietic Stem Cell Transplantation
Varicella Zoster InfectionHematopoietic 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.
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes...
Herpes ZosterThe purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.
Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster...
Herpes ZosterThe purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years...
VaricellaThis study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax which are indicated for active immunization for prevention of varicella. Total of 488 subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.
A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
VaricellaThe purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.
Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A)...
Herpes ZosterThe purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).
Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine...
Herpes ZosterThe purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
Herpes ZosterVaricella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. More than 99.6% of people 40 years of age orolder had evidence of previous VZV infection. This study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine. The investigational vaccines are produced by Changchun Changsheng biotechnology co. LTD. The incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination. And the safety of the varicella-zoster virus vaccine is also evaluated.
A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax...
Herpes ZosterA study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat treated VZV vaccine V212 or with Zostavax™. The enrollment of participants into this study was conducted in 2 parts, Part A and Part B. The first 42 eligible participants were enrolled into Part A of the study. In Part A, the reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners performing the reading at each timepoint; all subsequent skin test readings in Part A were performed at 48 hours post administration. After all skin test reactions were obtained at baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the frequency of baseline negative skin tests in order to confirm that the planned sample size (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours (post administration) in order to determine the preferred time for evaluation of the skin test reaction. The interim analysis from Part A confirmed the study sample size, an additional 78 subjects were enrolled into Part B to achieve the planned sample size (N=120). The study procedures for Part B of the study were identical to those in Part A with the following exceptions: (1) baseline skin test readings were performed only once, at either 48 or 72 hours (post administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was needed for the skin test reading at baseline.
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations...
Herpes ZosterThe goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.