title: Safety of attenuated smallpox vaccine LC16m8 in immunodeficient mice.
abstract: 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.
authors.affiliation: The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan yokote@kaketsuken.or.jp.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yokote
authors.affiliation: The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Shinmura
authors.affiliation: The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan.
authors.forename: Tomomi
authors.initials: T
authors.lastname: Kanehara
authors.affiliation: The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Maruno
authors.affiliation: The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kuranaga
authors.affiliation: The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Matsui
authors.affiliation: Chiba University, Yayoicho, Chiba-shi, Chiba, Japan.
authors.forename: So
authors.initials: S
authors.lastname: Hashizume
mesh_terms: D000818:Animals; D005260:Female; D016867:Immunocompromised Host; D007564:Japan; D008810:Mice, Inbred C57BL; D016513:Mice, SCID; D012900:Smallpox Vaccine / Q000009:adverse effects*; D014613:Vaccines, Attenuated / Q000009:adverse effects
chemical_list: D012900:Smallpox Vaccine; D014613:Vaccines, Attenuated; C539069:smallpox vaccine LC16m8