Efficacy and safety of live varicella vaccine (Oka) in patients with diabetes: a Randomized, Double-blind, Placebo-controlled, Single-center, Clinical Trial
| Project/Area Number |
22500686
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Applied health science
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| Research Institution | The Tazuke Kofukai |
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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)
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| Project Period (FY) |
2010-04-01 – 2015-03-31
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| Project Status |
Completed (Fiscal Year 2014)
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| Budget Amount *help |
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2014: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2013: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2012: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2011: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2010: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
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| 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 / 糖尿病 / 水痘帯状疱疹ウイルス / ウイルス特異的免疫能 / 肺炎球菌ワクチン / 帯状疱疹ワクチン / 特異的免疫能 |
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| 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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Report
(6 results)
Research Products
(13 results)
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[Journal Article] Efficacy and safety of live varicella vaccine in diabetes: a Randomized, Double-blind, Placebo-controlled Trial2015
Author(s)
Atsuko Hata, Fukue Inoue, Midori Yamasaki, Jun Fujikawa, Hiroyuki Kawahara, Yukiko Kawasaki, Yoshiyuki Hamamoto, Sachiko Honjo, Hiroyuki Koshiyama, Eiko Moriishi, Yasuko Mori, Takayoshi Ohkubo
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Journal Title
Vaccine (subimitted)
Volume: in print
Pages: 00-00
Related Report
Peer Reviewed / Acknowledgement Compliant
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[Journal Article] Safety, humoral and cell-mediated immune responses to herpes zoster vaccine in subjects with diabetes mellitus.2013
Author(s)
Hata A, Inoue F, Yamasaki M, Fujikawa J, Kawasaki Y, Hamamoto Y, Honjo S, Moriishi E, Mori Y, Koshiyama H.
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Journal Title
J Infect.
Volume: 67
Issue: 3
Pages: 215-219
DOI
Related Report
Peer Reviewed
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