US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccines Research and Review, Silver Spring, Maryland, USA.
J Infect Dis. 2020 Mar 5;221(Suppl 1):S103-S108. doi: 10.1093/infdis/jiz523.
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."
巨细胞病毒（CMV）给公共卫生带来了相当大的负担，这支持了目前对疫苗开发的兴趣。旨在支持监管行动的临床研究应旨在证明有充分的有效性证据。然而，临床终点研究的设计和进行可能会受到疾病发生率低的阻碍，特别是对于先天性 CMV。来自针对先天性疾病（包括风疹和寨卡病毒）的其他疫苗的讨论和经验可能具有指导意义。本文总结了 2018 年题为“巨细胞病毒感染：预防和治疗策略的进展”的研讨会讨论的与旨在预防先天性 CMV 和移植中 CMV 并发症的疫苗研究设计相关的当前科学和美国监管考虑因素。
