Scientific and Regulatory Considerations for Efficacy Studies of Cytomegalovirus Vaccines

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 endpoi...

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Veröffentlicht in:The Journal of infectious diseases 2020-03, Vol.221 (Supplement_1), p.S103-S108
Hauptverfasser: Krause, Philip R, Roberts, Jeff
Format: Artikel
Sprache:eng
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Zusammenfassung: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.”
ISSN:0022-1899
1537-6613
DOI:10.1093/infdis/jiz523