| 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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| 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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