Efficacy and safety of live varicella vaccine (Oka) in patients with diabetes: a Randomized, Double-blind, Placebo-controlled, Single-center, Clinical Trial

2014 Fiscal Year Final Research Report

• Project/Area Number: 22500686
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Applied health science
• Research Institution: The Tazuke Kofukai
• Principal Investigator: HATA Atsuko 公益財団法人田附興風会, 医学研究所 第4研究部, 研究主幹 (70321685)
• Project Period (FY): 2010-04-01 – 2015-03-31
• Keywords: 水痘ワクチン / 帯状疱疹 / 細胞性免疫 / 皮内テスト / ELISPOT / IAHA / PPSV23 / 同時接種

Outline of Final Research Achievements

This double-blind randomized controlled single-center study of 60-70-year-old patients with diabetes mellitus compared immunity and safety profiles after Varicella vaccine, separated by 3 months, vs. placebo. 23-valent pneumococcal polysaccharide vaccine (PPSV23) was immunized simultaneously. Primary analysis was cell mediated immunity evaluated using the Varicella-zoster virus skin test. Secondary analyses were VZV interferon-gamma enzyme-linked immunospot (ELISPOT) assay and immunoadherence hemagglutination (IAHA) test. Adverse experiences (AEs) were assessed. By intent-to-treat analysis, 27 recipients of the vaccine were compared with 27 placebo recipients. Changes of skin test scores were, respectively, 0.41±0.80 and 0.11±0.93 (p=0.22). No significant differences of ELISPOT and IAHA titer were found between vaccine and placebo groups from before to after vaccination. No severe AE occurred. The vaccine was used safely, but did not boost virus-specific immunity in this population.

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