Center for Vaccine Innovation and Access, PATH, Washington, D.C. 20001.
International Vaccine Institute, SNU Research Park, Gwanak-gu, Seoul 08826, Korea.
Cold Spring Harb Perspect Med. 2018 Nov 1;8(11):a032573. doi: 10.1101/cshperspect.a032573.
Soon after the 1991 molecular cloning of hepatitis E virus (HEV), recombinant viral capsid antigens were expressed and tested in nonhuman primates for protection against liver disease and infection. Two genotype 1 subunit vaccine candidates entered clinical development: a 56 kDA vaccine expressed in insect cells and HEV 239 vaccine expressed in Both were highly protective against hepatitis E and acceptably safe. The HEV 239 vaccine was approved in China in 2011, but it is not yet prequalified by the World Health Organization, a necessary step for introduction into those low- and middle-income countries where the disease burden is highest. Nevertheless, the stage is set for the final act in the hepatitis E vaccine story-policymaking, advocacy, and pilot introduction of vaccine in at-risk populations, in which it is expected to be cost-effective.
1991 年丙型肝炎病毒(HEV)的分子克隆后不久,重组病毒衣壳抗原在非人类灵长类动物中进行了表达和测试,以预防肝病和感染。两种基因型 1 亚单位疫苗候选物进入临床开发:一种在昆虫细胞中表达的 56kDa 疫苗和一种在酵母中表达的 HEV 239 疫苗。这两种疫苗都能高度预防戊型肝炎,且安全性可以接受。HEV 239 疫苗于 2011 年在中国获得批准,但尚未世界卫生组织预认证,这是将疫苗引入疾病负担最高的低收入和中等收入国家的必要步骤。然而,戊型肝炎疫苗故事的最后一幕——决策制定、宣传和在高危人群中试点引入疫苗——已经准备就绪,预计该疫苗具有成本效益。