Scientific and Regulatory Considerations for Efficacy Studies of Cytomegalovirus Vaccines.

Philip R Krause, Jeff Roberts

The Journal of infectious diseases 2020 Mar 05

filter terms:

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." Published by Oxford University Press for the Infectious Diseases Society of America 2020.

Citation

Philip R Krause, Jeff Roberts. Scientific and Regulatory Considerations for Efficacy Studies of Cytomegalovirus Vaccines. The Journal of infectious diseases. 2020 Mar 05;221(Suppl 1):S103-S108