論文

査読有り
2016年8月1日

Efficacy and safety of live varicella zoster vaccine in diabetes: a randomized, double-blind, placebo-controlled trial

Diabetic Medicine
  • A. Hata
  • F. Inoue
  • Y. Hamamoto
  • M. Yamasaki
  • J. Fujikawa
  • H. Kawahara
  • Y. Kawasaki
  • S. Honjo
  • H. Koshiyama
  • E. Moriishi
  • Y. Mori
  • T. Ohkubo
  • 全て表示

33
8
開始ページ
1094
終了ページ
1101
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1111/dme.13038
出版者・発行元
Blackwell Publishing Ltd

Aims: 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. Methods: 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. Results: 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. Discussion: 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.

リンク情報
DOI
https://doi.org/10.1111/dme.13038
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/26605507
ID情報
  • DOI : 10.1111/dme.13038
  • ISSN : 1464-5491
  • ISSN : 0742-3071
  • PubMed ID : 26605507
  • SCOPUS ID : 84978923003

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