Desirability and feasibility of a vaccine against cytomegalovirus

• Type of Material: Article
• Authors: Paul Griffiths, University College London; Stanley Plotkin, University of Pennsylvania; Edward Mocarski, Emory University; Robert Pass, University of Alabama Birmingham; Mark Schleiss, University of Minnesota; Philip Krause, Food and Drug Administration; Stephanie Bialek, Emory University
• Language: English
• Date: 2013-04-18
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2012 Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1016/j.vaccine.2012.10.074
• Title of Journal or Parent Work: Vaccine
• ISSN: 0264-410X
• Volume: 31
• Issue: SUPPL2
• Start Page: B197
• End Page: B203
• Grant/Funding Information: Work in the authors’ laboratories is supported by the following grants: Wellcome Trust 078332.
• Keywords: ELDERLY INDIVIDUALS; Medicine, Research & Experimental; Vaccine; CD8(+) T-CELLS; ANTIRETROVIRAL THERAPY; Science & Technology; Reinfection; MEDICINE, RESEARCH & EXPERIMENTAL; LIVER-TRANSPLANTATION; Burden of disease; IMMUNOCOMPROMISED HOSTS; IMMUNOLOGY; Clinical trials; VIRUS-INFECTION; GLYCOPROTEIN-B VACCINE; PLACEBO-CONTROLLED TRIAL; Immunology; Life Sciences & Biomedicine; TRANSPLANT RECIPIENTS; Hearing loss; RENAL-TRANSPLANTATION; Prevention; Research & Experimental Medicine
• Research Categories: Biology, Microbiology; Health Sciences, Immunology; Biology, Virology

Abstract

Publication of a report from the Institute of Medicine in 2000 showing that a vaccine against cytomegalovirus (CMV) would likely be cost saving was very influential and encouraged the clinical evaluation of candidate vaccines. The major objective of a CMV vaccination program would be to reduce disease caused by congenital CMV infection, which is the leading viral cause of sensorineural hearing loss and neurodevelopmental delay.CMV has challenges as a vaccine target because it is a herpesvirus, it persists lifelong despite host immunity, infected individuals can be reinfected with new strains, overt disease occurs in those with immature or impaired immune systems and persons with this infection do not usually report symptoms. Nevertheless , natural immunity against CMV provides some protection against infection and disease, natural history studies have defined the serological and molecular biological techniques needed for endpoints in future clinical trials of vaccines and CMV is not highly communicable, suggesting that it may not be necessary to achieve very high levels of population immunity through vaccination in order to affect transmission. Three phase 2 CMV vaccine studies have been completed in the last 3 years and all report encouraging outcomes.A key international meeting was organized by the Food and Drug Administration in January 2012 at which interested parties from regulatory bodies, industry and academia discussed and prioritised designs for phase 2 and phase 3 clinical trials. Vaccines able to prevent primary infection with CMV and to boost the immune response of those already infected are desirable. The major target populations for a CMV vaccine include women of childbearing age and adolescents. Toddlers represent another potential population, since an effect of vaccine in this age group could potentially decrease transmission to adults. In addition, prospective recipients of transplants and patients with AIDS would be expected to benefit.