Yokote Hiroyuki, Shinmura Yasuhiko, Kanehara Tomomi, Maruno Shinichi, Kuranaga Masahiko, Matsui Hajime, Hashizume So
The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan
The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan.
Clin Vaccine Immunol. 2014 Sep;21(9):1261-6. doi: 10.1128/CVI.00199-14. Epub 2014 Jul 2.
Freeze-dried live attenuated smallpox vaccine LC16m8 prepared in cell culture has been the sole smallpox vaccine licensed in Japan since 1975 and was recently recommended as a WHO stockpile vaccine. We evaluated the safety of recently remanufactured lots of LC16m8 using a series of immunodeficient mouse models. These models included suckling mice, severe combined immunodeficiency disease (SCID) mice, and wild-type mice treated with cyclosporine. LC16m8 showed extremely low virulence in each of the three mouse models compared with that of its parental strains, Lister and LC16mO. These results provide further evidence that LC16m8 is one of the safest replication-competent smallpox vaccines in the world and may be considered for use in immunodeficient patients.
自1975年以来,在细胞培养中制备的冻干减毒活天花疫苗LC16m8一直是日本唯一获得许可的天花疫苗,最近被推荐作为世界卫生组织的储备疫苗。我们使用一系列免疫缺陷小鼠模型评估了最近重新生产的批次的LC16m8的安全性。这些模型包括乳鼠、严重联合免疫缺陷病(SCID)小鼠和用环孢素处理的野生型小鼠。与亲代菌株李斯特菌和LC16mO相比,LC16m8在三种小鼠模型中的毒力极低。这些结果进一步证明LC16m8是世界上最安全的具有复制能力的天花疫苗之一,可考虑用于免疫缺陷患者。