{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T04:16:49Z","timestamp":1790482609521,"version":"4.1.0"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","funder":[{"name":"US Food and Drug Administration, Center for Biologics Evaluation and Research"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,3,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>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 \u201cCytomegalovirus Infection: Advancing Strategies for Prevention and Treatment.\u201d<\/jats:p>","DOI":"10.1093\/infdis\/jiz523","type":"journal-article","created":{"date-parts":[[2019,10,11]],"date-time":"2019-10-11T03:49:41Z","timestamp":1570765781000},"page":"S103-S108","source":"Crossref","is-referenced-by-count":11,"title":["Scientific and Regulatory Considerations for Efficacy Studies of Cytomegalovirus Vaccines"],"prefix":"10.1093","volume":"221","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1045-7536","authenticated-orcid":false,"given":"Philip R","family":"Krause","sequence":"first","affiliation":[{"name":"US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccines Research and Review, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff","family":"Roberts","sequence":"first","affiliation":[{"name":"US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccines Research and Review, Silver Spring, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,3,5]]},"reference":[{"key":"2020030507500869300_CIT0001","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1016\/j.vaccine.2013.09.042","article-title":"Priorities for CMV vaccine development","volume":"32","author":"Krause","year":"2013","journal-title":"Vaccine"},{"key":"2020030507500869300_CIT0002","doi-asserted-by":"crossref","first-page":"1256","DOI":"10.1016\/S0140-6736(11)60136-0","article-title":"Cytomegalovirus glycoprotein-B vaccine with MF59 adjuvant in transplant recipients: a phase 2 randomised placebo-controlled trial","volume":"377","author":"Griffiths","year":"2011","journal-title":"Lancet"},{"key":"2020030507500869300_CIT0003","doi-asserted-by":"crossref","first-page":"525","DOI":"10.7326\/0003-4819-114-7-525","article-title":"Effect of Towne live virus vaccine on cytomegalovirus disease after renal transplant. A controlled trial","volume":"114","author":"Plotkin","year":"1991","journal-title":"Ann Intern Med"},{"key":"2020030507500869300_CIT0004","doi-asserted-by":"crossref","first-page":"2945","DOI":"10.1111\/ajt.14925","article-title":"A randomized, phase 2 study of ASP0113, a DNA-based vaccine, for the prevention of CMV in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor","volume":"18","author":"Vincenti","year":"2018","journal-title":"Am J Transplant"},{"key":"2020030507500869300_CIT0005","volume-title":"Astellas and Vical Announce Top-Line Results for Phase","year":"2018"},{"key":"2020030507500869300_CIT0006","doi-asserted-by":"crossref","first-page":"2433","DOI":"10.1056\/NEJMoa1706640","article-title":"Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation","volume":"377","author":"Marty","year":"2017","journal-title":"N Engl J Med"},{"key":"2020030507500869300_CIT0007","article-title":"A mortality analysis of 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