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Replacement method for vaccine potency tests

Research Project

Project/Area Number 25350587
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical engineering assessment
Research InstitutionNational Institute of Infectious Diseases

Principal Investigator

Iwaki Masaaki  国立感染症研究所, 細菌第二部, 主任研究官 (20176530)

Co-Investigator(Renkei-kenkyūsha) KENRI Tsuyoshi  国立感染症研究所, 細菌第二部, 主任研究官 (80270643)
SATO Toshinori  慶應義塾大学, 理工学部, 教授 (00162454)
Research Collaborator SHIMASAKI Noriko  国立感染症研究所, インフルエンザウイルス研究センター, 研究員
Project Period (FY) 2013-04-01 – 2017-03-31
Project Status Completed (Fiscal Year 2016)
Budget Amount *help
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2015: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2014: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2013: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Keywordsワクチン / 品質管理 / 動物福祉 / 力価試験 / 破傷風 / 動物実験 / 3Rs / 生物製剤 / DPT
Outline of Final Research Achievements

Quality control of vaccines largely rely on animal experiments. Potency tests for tetanus toxoids employ animal challenge with tetanus toxin sometimes stressful to animals. To avoid unnecessary stress by in vivo challenge method, we tried to construct a system for tetanus toxoid potency test, with less stress to animals. The test system needs to measure toxin-neutralizing activity in immunized animals accurately and sensitively enough to be applied in quality control of vaccines. Our results suggest, although not immediately applicable to routine testing, a possibility of developing an in vitro test system by further studies.

Report

(5 results)
  • 2016 Annual Research Report   Final Research Report ( PDF )
  • 2015 Research-status Report
  • 2014 Research-status Report
  • 2013 Research-status Report

URL: 

Published: 2014-07-25   Modified: 2019-07-29  

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