Safety of Attenuated Smallpox Vaccine LC16m8 in Immunodeficient Mice

Author:

Yokote Hiroyuki1,Shinmura Yasuhiko1,Kanehara Tomomi1,Maruno Shinichi1,Kuranaga Masahiko1,Matsui Hajime1,Hashizume So2

Affiliation:

1. The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), Okubo, Kita-ku Kumamoto-shi, Kumamoto, Japan

2. Chiba University, Yayoicho, Chiba-shi, Chiba, Japan

Abstract

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.

Publisher

American Society for Microbiology

Subject

Microbiology (medical),Clinical Biochemistry,Immunology,Immunology and Allergy

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