期刊
JOURNAL OF INFECTIOUS DISEASES
卷 221, 期 -, 页码 103-108出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiz523
关键词
congenital CMV; CMV in transplantation; cytomegalovirus; vaccines
资金
- US Food and Drug Administration, Center for Biologics Evaluation and Research
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.
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