title: Cytomegalovirus vaccine: phase II clinical trial results.
abstract: Cytomegalovirus (CMV) is one of the most significant viral pathogens during pregnancy and in immunocompromised patients. Antiviral prophylactic strategies are limited by toxicities, drug-drug interactions and development of antiviral resistance. A safe and protective vaccine against CMV is highly desirable in view of the potential positive impact on CMV-associated morbidity and mortality as well as healthcare costs. Unfortunately, this demand could not be met in the past four decades although development of a CMV vaccine has been ranked at the highest priority by the US Institute of Medicine. Multiple different vaccine candidates have been developed and evaluated in phase I clinical trials and few succeeded to phase II trials. Nevertheless, two different vaccines showed recently promising results in trials that studied healthy adults and immunocompromised solid-organ and bone-marrow transplant recipients, respectively. The gB/MF59 vaccine exhibited a vaccine efficacy of 50% in healthy, postpartum females. In transplant patients, gB/MF59 and the DNA vaccine TransVax both limited the periods of viraemia and consequently the need for antiviral treatment. The success of these trials is encouraging and will probably give new impetus to the development of an effective CMV vaccine. Sterilizing immunity may not be attainable in the near future and may not be necessary for a CMV vaccine to have a significant impact on health care as discussed in the present review.
authors.affiliation: Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: F
authors.initials: F
authors.lastname: Rieder
authors.forename: C
authors.initials: C
authors.lastname: Steininger
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D003587:Cytomegalovirus; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D022482:Cytomegalovirus Vaccines / Q000627:therapeutic use*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D016867:Immunocompromised Host / Q000276:immunology; D049590:Postpartum Period / Q000276:immunology; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic; D066027:Transplant Recipients; D014611:Vaccination; D014766:Viremia / Q000517:prevention & control
chemical_list: D022482:Cytomegalovirus Vaccines
keywords: Cytomegalovirus; glycoproteins; human immunodeficiency virus; immunology; intrauterine infection; pentameric complex; transplantation; vaccine