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首页> 美国政府科技报告 >Safety Testing of Seed and Vaccines for Dengue Viruses in Mice, Guinea Pigs, Rabbits and Bacterial and Mycoplasma Culture Media.
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Safety Testing of Seed and Vaccines for Dengue Viruses in Mice, Guinea Pigs, Rabbits and Bacterial and Mycoplasma Culture Media.

机译：小鼠，豚鼠，家兔和细菌和支原体培养基中登革病毒种子和疫苗的安全性检测。

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Preclinical safety testing of dengue virus production seeds consisted of inoculation in: (1) 5 different cell culture lines; (2) rabbits, mice (adult newborn sucklings) and guinea pigs; and (3) bacterial fungal and mycoplasma culture media. Inocula for these tests were the crude, unclarified harvests of both control and virus fluids. For dengue-1, 3 different PDK passage levels were grown in FRhL-2 cells and the same for dengue-4. All tests carried out following guidelines established by the FDA for live and inactivated virus vaccines as found in 21 CFR, Part 600 and were performed in accordance with GLP regulations. A dengue-1 vaccine lot was subjected to 20 additional serial passages (total 30) in dog kidney cell cultures in attempts at further attenuation. Problems with lack of high-titered immune serum resulted in unsatisfactory findings in tissue culture purity (AGMK cells) for both viruses and in suckling mice tests with dengue-4 viruses.

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