Sohn Y M, Park M S, Rho H O, Chandler L J, Shope R E, Tsai T F
Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
Vaccine. 1999 May 4;17(18):2259-64. doi: 10.1016/s0264-410x(99)00006-7.
Attenuated SA14-14-2 Japanese encephalitis (JE) vaccine has been administered safely and effectively to more than 100 million children in China since 1988 and recently, licensure of the vaccine in Korea has been sought. In the first clinical evaluation of the vaccine outside of China, we monitored side effects in 84 children and evaluated antibody responses to a single dose given as primary JE vaccination in 68 children, 1-3 years old (mean age 27 months). No significant adverse events were noted. Neutralizing antibodies (geometric mean titer [GMT] of 188) were produced in 96% of the 68 subjects. In 10 other children who previously had been immunized with two or three doses of inactivated JE vaccine, the booster administration of SA14-14-2 vaccine produced an anamnestic response in all, with a GMT of 3378. In a comparison group of 25 children previously immunized with two doses of inactivated vaccine, neutralizing antibody titers were detected in 16 (64%). Viral specific IgM was detected in nine primary vaccinees (13%) but in others, IgM may have declined to undetectable levels in the four week postimmunization sample. Live attenuated SA14-14-2 JE vaccine is a promising alternative to the only commercially available JE vaccine for national childhood immunization programs in Asia.
自1988年以来，减毒SA14-14-2日本脑炎（乙脑）疫苗已在中国超过1亿儿童中安全有效地接种，最近，韩国正在寻求该疫苗的上市许可。在中国境外对该疫苗进行的首次临床评估中，我们监测了84名儿童的副作用，并评估了68名1至3岁（平均年龄27个月）儿童作为乙脑初次疫苗接种单剂量后的抗体反应。未观察到显著不良事件。68名受试者中有96%产生了中和抗体（几何平均滴度[GMT]为188）。在另外10名先前已接种两剂或三剂灭活乙脑疫苗的儿童中，SA14-14-2疫苗的加强接种在所有人中均产生了回忆反应，GMT为3378。在一个由25名先前接种过两剂灭活疫苗的儿童组成的对照组中，16名（64%）检测到中和抗体滴度。在9名初次接种疫苗者（13%）中检测到病毒特异性IgM，但在其他受试者中，IgM可能在免疫后四周的样本中降至无法检测的水平。减毒活SA14-14-2乙脑疫苗是亚洲国家儿童免疫规划中唯一可商购的乙脑疫苗的一种有前景的替代疫苗。
