University College London, UK.
Vaccine. 2013 Apr 18;31 Suppl 2(Suppl 2):B197-203. doi: 10.1016/j.vaccine.2012.10.074.
Publication of a report from the Institute of Medicine in 2000 showing that a vaccine against cytomegalovirus (CMV) would likely be cost saving was very influential and encouraged the clinical evaluation of candidate vaccines. The major objective of a CMV vaccination program would be to reduce disease caused by congenital CMV infection, which is the leading viral cause of sensorineural hearing loss and neurodevelopmental delay. CMV has challenges as a vaccine target because it is a herpesvirus, it persists lifelong despite host immunity, infected individuals can be reinfected with new strains, overt disease occurs in those with immature or impaired immune systems and persons with this infection do not usually report symptoms. Nevertheless, natural immunity against CMV provides some protection against infection and disease, natural history studies have defined the serological and molecular biological techniques needed for endpoints in future clinical trials of vaccines and CMV is not highly communicable, suggesting that it may not be necessary to achieve very high levels of population immunity through vaccination in order to affect transmission. Three phase 2 CMV vaccine studies have been completed in the last 3 years and all report encouraging outcomes. A key international meeting was organized by the Food and Drug Administration in January 2012 at which interested parties from regulatory bodies, industry and academia discussed and prioritised designs for phase 2 and phase 3 clinical trials. Vaccines able to prevent primary infection with CMV and to boost the immune response of those already infected are desirable. The major target populations for a CMV vaccine include women of childbearing age and adolescents. Toddlers represent another potential population, since an effect of vaccine in this age group could potentially decrease transmission to adults. In addition, prospective recipients of transplants and patients with AIDS would be expected to benefit.
2000 年，美国医学研究所发布的一份报告表明，针对巨细胞病毒（CMV）的疫苗可能具有成本效益，这一报告极具影响力，鼓励了候选疫苗的临床评估。CMV 疫苗接种计划的主要目标是减少由先天性 CMV 感染引起的疾病，先天性 CMV 感染是导致感觉神经性听力损失和神经发育迟缓的主要病毒病因。CMV 作为疫苗靶点具有挑战性，因为它是一种疱疹病毒，尽管宿主具有免疫力，但它会终身持续存在，感染个体可能会被新的毒株再次感染，显性疾病发生在免疫系统不成熟或受损的个体中，并且患有这种感染的人通常不会报告症状。然而，针对 CMV 的自然免疫提供了一些针对感染和疾病的保护，自然史研究已经确定了未来 CMV 疫苗临床试验终点所需的血清学和分子生物学技术，并且 CMV 的传染性不高，这表明为了影响传播，可能无需通过接种疫苗来实现非常高的人群免疫力。在过去的 3 年中，已经完成了 3 项 CMV 疫苗 2 期研究，所有研究都报告了令人鼓舞的结果。美国食品和药物管理局于 2012 年 1 月组织了一次关键的国际会议，来自监管机构、行业和学术界的相关方讨论并确定了 2 期和 3 期临床试验的设计优先级。能够预防 CMV 原发性感染并增强已感染者免疫反应的疫苗是理想的。CMV 疫苗的主要目标人群包括育龄妇女和青少年。幼儿是另一个潜在的目标人群，因为该年龄组的疫苗效果可能会降低向成年人的传播。此外，预期接受移植的患者和艾滋病患者将受益。
