Eto Akiko, Saito Tomoya, Yokote Hiroyuki, Kurane Ichiro, Kanatani Yasuhiro
Department of Health Crisis Management, National Institute of Public Health, 2-3-6 Minami, Wako-shi, 351-0197, Saitama, Japan.
Chemo-Sero-Therapeutic Research Institute (Kaketsuken), 1-6-1 Okubo, Kita-ku, Kumamoto-shi, 860-8568, Kumamoto, Japan.
Vaccine. 2015 Nov 9;33(45):6106-11. doi: 10.1016/j.vaccine.2015.07.111. Epub 2015 Aug 28.
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.
LC16m8是一种减毒活细胞培养天花疫苗，于20世纪70年代在日本研发并获得许可，但未用于天花根除运动。21世纪初，生物恐怖主义的潜在威胁促使人们重新审视天花疫苗的必要性。随后，2002年日本重启了LC16m8的生产，这需要对其安全性和有效性进行重新评估。20世纪70年代，日本约5万名儿童接种了LC16m8，21世纪初约3500名健康成年人接种了该疫苗，在美国的I/II期临床试验中，有153名成年人接种了LC16m8或Dryvax。这些研究证实了LC16m8的安全性和有效性，同时在动物模型中的多项研究表明，LC16m8能保护宿主免受病毒攻击。2013年，世界卫生组织免疫战略咨询专家组推荐LC16m8与ACAM2000作为储备疫苗。此外，LC16m8有望成为第一代天花疫苗预防人类猴痘的可行替代品。
