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Safety and Immunogenicity of Heat-Treated Zoster Vaccine (ZVHT) in Immunocompromised Adults
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Safety and Immunogenicity of Heat-Treated Zoster Vaccine (ZVHT) in Immunocompromised Adults
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Safety and Immunogenicity of Heat-Treated Zoster Vaccine (ZVHT) in Immunocompromised Adults
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Journal Article
Safety and Immunogenicity of Heat-Treated Zoster Vaccine (ZVHT) in Immunocompromised Adults
2013
Overview
Background. Safety and immunogenicity of heat-treated zoster vaccine (ZV HT ) were assessed in immunocompromised adults. Methods. In a randomized, double-blind, placebo–controlled, multicenter study, 4 doses ZV HT or placebo were administered approximately 30 days apart to adults with either solid tumor malignancy (STM); hematologic malignancy (HM); human immunodeficiency virus (HIV) with CD4⁺ ≤200; autologous hematopoietic stem-cell transplant (HCT) or allogeneic-HCT recipients. Varicella-zoster virus (VZV) T-cell responses by interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) and VZV antibody concentrations by glycoprotein enzyme-linked immunosorbent assay (gpELISA) were measured at baseline and approximately 28 days after each dose. Results. No safety signals were found in any group. IFN-γ ELISPOT geometric mean fold rises (GMFR) after dose 4 in STM, HM, HIV, and autologous-HCT patients were 3.00 (P<.0001), 2.23 (P = .004), 1.76 (P = .026), and 9.01 (P = NA), respectively. Similarly, antibody GMFR were 2.35 (P<. 0001), 1.28 (P = . 003), 1.37 (P = .017), and 0.90 (P = NA), respectively. T-cell and antibody responses were poor after 4 doses of ZV HT m allogeneic-HCT patients. Conclusion. ZV HT was generally safe and immunogenic through 28 days post-dose 4 in adults with STM, HM, and HIV. Autologous-HCT but not allogeneic-HCT patients had a rise in T-cell response; antibody responses were not increased in either HCT population. Study identification. V212-002 Clinical Trials Registration. NCT00535236
Publisher
Oxford University Press
Subject
/ Aged
/ Biological and medical sciences
/ Female
/ Fundamental and applied biological sciences. Psychology
/ Hematopoietic Stem Cell Transplantation
/ Herpes Zoster - prevention & control
/ Herpes Zoster Vaccine - adverse effects
/ Herpes Zoster Vaccine - immunology
/ HIV
/ Human immunodeficiency virus
/ Humans
/ Male
/ Placebos
/ Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
/ Vaccines, Attenuated - adverse effects
/ Vaccines, Attenuated - immunology
/ VIRUSES
