Anderholm K M, Bierle C J, Schleiss M R
Division of Pediatric Infectious Diseases and Immunology, Department of Pediatrics, Center for Infectious Diseases and Microbiology Translational Research, University of Minnesota Medical School, 2001 6th Street SE, Minneapolis, MN, 55455, USA.
Drugs. 2016 Nov;76(17):1625-1645. doi: 10.1007/s40265-016-0653-5.
Congenital human cytomegalovirus (HCMV) infection can result in severe and permanent neurological injury in newborns, and vaccine development is accordingly a major public health priority. HCMV can also cause disease in solid organ transplant (SOT) and hematopoietic stem-cell transplant (HSCT) recipients, and a vaccine would be valuable in prevention of viremia and end-organ disease in these populations. Currently there is no licensed HCMV vaccine, but progress toward this goal has been made in recent clinical trials. A recombinant HCMV glycoprotein B (gB) vaccine has been shown to have some efficacy in prevention of infection in young women and adolescents, and has provided benefit to HCMV-seronegative SOT recipients. Similarly, DNA vaccines based on gB and the immunodominant T-cell target, pp65 (ppUL83), have been shown to reduce viremia in HSCT patients. This review provides an overview of HCMV vaccine candidates in various stages of development, as well as an update on the current status of ongoing clinical trials. Protective correlates of vaccine-induced immunity may be different for pregnant woman and transplant patients. As more knowledge emerges about correlates of protection, the ultimate licensure of HCMV vaccines may reflect the uniqueness of the target populations being immunized.
先天性人巨细胞病毒(HCMV)感染可导致新生儿严重且永久性的神经损伤,因此疫苗研发是一项重大的公共卫生优先事项。HCMV还可在实体器官移植(SOT)受者和造血干细胞移植(HSCT)受者中引发疾病,疫苗对于预防这些人群的病毒血症和终末器官疾病将具有重要价值。目前尚无获得许可的HCMV疫苗,但近期的临床试验已朝着这一目标取得了进展。一种重组HCMV糖蛋白B(gB)疫苗已显示出在预防年轻女性和青少年感染方面具有一定疗效,并已使HCMV血清阴性的SOT受者受益。同样,基于gB和免疫显性T细胞靶点pp65(ppUL83)的DNA疫苗已显示出可降低HSCT患者的病毒血症。本综述概述了处于不同研发阶段的HCMV候选疫苗,以及正在进行的临床试验的最新情况。疫苗诱导免疫的保护性相关因素对于孕妇和移植患者可能有所不同。随着对保护相关因素的了解越来越多,HCMV疫苗的最终获批可能会反映出所免疫目标人群的独特性。