A Hata1, F Inoue1, Y Hamamoto2, M Yamasaki3, J Fujikawa3, H Kawahara4, Y Kawasaki2, S Honjo2, H Koshiyama2, E Moriishi5, Y Mori5,6, T Ohkubo7. 1. Department of Infectious Diseases, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan. 2. Center for Diabetes and Endocrinology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan. 3. Department of Laboratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan. 4. Department of Pharmacy, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan. 5. Laboratory of Virology and Vaccinology, Division of Biomedical Research, National Institute of Biomedical Innovation, Ibaraki, Japan. 6. Division of Clinical Virology, Department of Microbiology and Infectious Diseases, Kobe University Graduate School of Medicine, Kobe, Japan. 7. Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.
Abstract
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 aplacebo. 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.
RCT Entities:
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.
Authors: Anna Mz Gagliardi; Brenda Ng Andriolo; Maria Regina Torloni; Bernardo Go Soares; Juliana de Oliveira Gomes; Regis B Andriolo; Eduardo Canteiro Cruz Journal: Cochrane Database Syst Rev Date: 2019-11-07
Authors: Andrea C Tricco; Wasifa Zarin; Roberta Cardoso; Areti-Angeliki Veroniki; Paul A Khan; Vera Nincic; Marco Ghassemi; Rachel Warren; Jane P Sharpe; Andrea V Page; Sharon E Straus Journal: BMJ Date: 2018-10-25