title: Recent advances in the study of live attenuated cell-cultured smallpox vaccine LC16m8.
abstract: LC16m8 is a live, attenuated, cell-cultured smallpox vaccine that was developed and licensed in Japan in the 1970s, but was not used in the campaign to eradicate smallpox. In the early 2000s, the potential threat of bioterrorism led to reconsideration of the need for a smallpox vaccine. Subsequently, LC16m8 production was restarted in Japan in 2002, requiring re-evaluation of its safety and efficacy. Approximately 50,000 children in the 1970s and about 3500 healthy adults in the 2000s were vaccinated with LC16m8 in Japan, and 153 adults have been vaccinated with LC16m8 or Dryvax in phase I/II clinical trials in the USA. These studies confirmed the safety and efficacy of LC16m8, while several studies in animal models have shown that LC16m8 protects the host against viral challenge. The World Health Organization Strategic Advisory Group of Experts on Immunization recommended LC16m8, together with ACAM2000, as a stockpile vaccine in 2013. In addition, LC16m8 is expected to be a viable alternative to first-generation smallpox vaccines to prevent human monkeypox.
authors: Department of Health Crisis Management, National Institute of Public Health, 2-3-6 Minami, Wako-shi, 351-0197, Saitama, Japan.
authors: Akiko
authors: A
authors: Eto
authors: Department of Health Crisis Management, National Institute of Public Health, 2-3-6 Minami, Wako-shi, 351-0197, Saitama, Japan.
authors: Tomoya
authors: T
authors: Saito
authors: Chemo-Sero-Therapeutic Research Institute (Kaketsuken), 1-6-1 Okubo, Kita-ku, Kumamoto-shi, 860-8568, Kumamoto, Japan.
authors: Hiroyuki
authors: H
authors: Yokote
authors: National Institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, 162-8640, Tokyo, Japan.
authors: Ichiro
authors: I
authors: Kurane
authors: Department of Health Crisis Management, National Institute of Public Health, 2-3-6 Minami, Wako-shi, 351-0197, Saitama, Japan. Electronic address: ykanatani@niph.go.jp.
authors: Yasuhiro
authors: Y
authors: Kanatani
mesh_terms: D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D023482:Bioterrorism; D018929:Cell Culture Techniques; D002986:Clinical Trials as Topic; D004195:Disease Models, Animal; D006801:Humans; D007564:Japan; D051379:Mice; D045908:Mpox, Monkeypox / Q000517:prevention & control*; D012899:Smallpox / Q000517:prevention & control*; D012900:Smallpox Vaccine / Q000009:adverse effects / Q000276:immunology*; D062205:Strategic Stockpile; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014616:Vaccinia virus / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; C078786:DryVax vaccine; D012900:Smallpox Vaccine; D014613:Vaccines, Attenuated; C539069:smallpox vaccine LC16m8
keywords: Anti-terrorism; LC16m8; Monkeypox; Smallpox vaccine