AI Article Synopsis
- The public health impact of cytomegalovirus (CMV) has spurred interest in developing vaccines to combat it.
- Clinical studies for these vaccines face challenges due to the low incidence of congenital CMV, which complicates proving their effectiveness.
- Insights from other congenital disease vaccines like rubella and Zika, along with regulatory considerations, are important for designing studies aimed at preventing CMV-related complications.
Article Abstract
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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| http://dx.doi.org/10.1093/infdis/jiz523 | DOI Listing |
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