The considerable public health burden due to cytomegalovirus (CMV) supports current interest in vaccine development. Clinical studies intended to support regulatory action should be designed to demonstrate substantial evidence of effectiveness. However, design and conduct of clinical endpoint studies may be hampered by low incidence of disease, especially for congenital CMV. Discussion and experience from other vaccines directed against congenital disease (including rubella and Zika) may be instructive. This article summarizes current scientific and US regulatory considerations related to design of studies of vaccines intended to prevent congenital CMV and complications of CMV in transplantation, as discussed at the 2018 workshop entitled “Cytomegalovirus Infection: Advancing Strategies for Prevention and Treatment.”

中文翻译：

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巨细胞病毒疫苗功效研究的科学和法规考虑

巨细胞病毒（CMV）造成的巨大公共卫生负担支持了当前对疫苗开发的兴趣。旨在支持调节作用的临床研究应设计为证明有效性的充分证据。但是，疾病的低发率可能会阻碍临床终点研究的设计和开展，尤其是对于先天性巨细胞病毒。其他针对先天性疾病的疫苗（包括风疹和寨卡病毒）的讨论和经验可能具有指导意义。本文概述了与旨在预防先天性巨细胞病毒和CMV移植并发症的疫苗研究设计有关的当前科学和美国监管考虑，正如2018年名为``巨细胞病毒感染：预防和治疗的先进策略''研讨会上讨论的那样。