title: Efficacy and safety of live varicella zoster vaccine in diabetes: a randomized, double-blind, placebo-controlled trial.
abstract: To elucidate varicella zoster virus (VZV)-specific cell-mediated immunity and humoral immunogenicity against live attenuated Oka varicella zoster vaccine concurrently vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) in elderly people with diabetes mellitus.
  
  
  
  This double-blind randomized controlled single-centre study of 60-70-year-old people with diabetes compared immunity and safety profiles 3 months after one dose of varicella zoster vaccine or placebo. PPSV23 was immunized simultaneously. Primary analysis evaluated cell-mediated immunity using the VZV skin test. Secondary analyses were a VZV interferon-γ enzyme-linked immunospot (ELISPOT) assay and immunoadherence haemagglutination test. Adverse experiences were recorded using diary questionnaires.
  
  
  
  By intent-to-treat analysis, 27 participants with diabetes who had been administered the vaccine were compared with 27 participants who were given a placebo. Changes in skin test scores were 0.41 ± 0.80 and 0.11 ± 0.93 (P = 0.2155), and geometric mean fold rises of the ELISPOT counts were 1.2 [95% confidence interval (CI) 0.2, 7.9] and 1.2 (95% CI 0.2, 7.3) (P = 0.989) in the vaccine and placebo groups, respectively. The geometric mean titre did not increase 3 months after vaccination in either group. No vaccination-related severe adverse experience was reported and no participant developed herpes zoster.
  
  
  
  Our previous results demonstrated that varicella zoster vaccine safely enhanced VZV-specific immunity in elderly people with or without diabetes. The results of this study showed that varicella zoster vaccine can be used safely, but it cannot boost virus-specific immunity in elderly people with diabetes when administered with concurrent PPSV23. Alternative strategies are needed to prevent VZV-associated diseases in this population.
authors.affiliation: Department of Infectious Diseases, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: A
authors.identifier: 0000-0002-9131-0797
authors.initials: A
authors.lastname: Hata
authors.affiliation: Department of Infectious Diseases, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: F
authors.initials: F
authors.lastname: Inoue
authors.affiliation: Center for Diabetes and Endocrinology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Hamamoto
authors.affiliation: Department of Laboratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Yamasaki
authors.affiliation: Department of Laboratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Fujikawa
authors.affiliation: Department of Pharmacy, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Kawahara
authors.affiliation: Center for Diabetes and Endocrinology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Kawasaki
authors.affiliation: Center for Diabetes and Endocrinology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Honjo
authors.affiliation: Center for Diabetes and Endocrinology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Koshiyama
authors.affiliation: Laboratory of Virology and Vaccinology, Division of Biomedical Research, National Institute of Biomedical Innovation, Ibaraki, Japan.
authors.forename: E
authors.initials: E
authors.lastname: Moriishi
authors.affiliation: Laboratory of Virology and Vaccinology, Division of Biomedical Research, National Institute of Biomedical Innovation, Ibaraki, Japan.|Division of Clinical Virology, Department of Microbiology and Infectious Diseases, Kobe University Graduate School of Medicine, Kobe, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Mori
authors.affiliation: Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ohkubo
mesh_terms: D000368:Aged; D003920:Diabetes Mellitus / Q000276:immunology*; D004311:Double-Blind Method; D058501:Enzyme-Linked Immunospot Assay; D005260:Female; D006562:Herpes Zoster / Q000276:immunology* / Q000517:prevention & control; D053061:Herpes Zoster Vaccine / Q000276:immunology* / Q000627:therapeutic use; D014645:Herpesvirus 3, Human / Q000276:immunology; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology*; D000071497:Immunogenicity, Vaccine / Q000276:immunology*; D000075662:Injection Site Reaction / Q000453:epidemiology / Q000209:etiology; D059425:Interferon-gamma Release Tests; D008297:Male; D008875:Middle Aged; D011008:Pneumococcal Infections / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000627:therapeutic use; D011537:Pruritus / Q000139:chemically induced / Q000453:epidemiology; D012882:Skin Tests
chemical_list: C414006:23-valent pneumococcal capsular polysaccharide vaccine; D053061:Herpes Zoster Vaccine; D022242:Pneumococcal Vaccines