title: Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial.
abstract: BACKGROUND
  Cytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development.
  
  
  METHODS
  CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens.
  
  
  RESULTS
  402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400 EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95%CI: -36; 76, p=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95%CI: -9; 72, p=0.08.
  
  
  CONCLUSIONS
  The vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al. N Engl J Med 2009;360:1191) using the same formulation.
authors.affiliation: Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States. Electronic address: David.Bernstein@cchmc.org.
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.affiliation: Baylor College of Medicine, Houston, TX, United States.
authors.forename: Flor M
authors.initials: FM
authors.lastname: Munoz
authors.affiliation: Vanderbilt University Medical Center, Nashville, TN, United States.
authors.forename: S Todd
authors.initials: ST
authors.lastname: Callahan
authors.affiliation: University of Texas Medical Branch at Galveston, Galveston, TX, United States.
authors.forename: Richard
authors.initials: R
authors.lastname: Rupp
authors.affiliation: University of Texas Health Science Center at Houston, Houston, TX, United States.
authors.forename: Susan H
authors.initials: SH
authors.lastname: Wootton
authors.affiliation: Vanderbilt University Medical Center, Nashville, TN, United States.
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Edwards
authors.affiliation: University of Texas Medical Branch at Galveston, Galveston, TX, United States; University of South Carolina School of Medicine, Columbia, SC, United States.
authors.forename: Christine B
authors.initials: CB
authors.lastname: Turley
authors.affiliation: University of Texas Medical Branch at Galveston, Galveston, TX, United States; Columbia University, New York Presbyterian Hospital, New York City, NY, United States.
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Stanberry
authors.affiliation: Baylor College of Medicine, Houston, TX, United States.
authors.forename: Shital M
authors.initials: SM
authors.lastname: Patel
authors.affiliation: Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States.
authors.forename: Monica M
authors.initials: MM
authors.lastname: Mcneal
authors.affiliation: Sanofi Pasteur, Marcy L'Etoile, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Pichon
authors.affiliation: The Emmes Corporation, Rockville, MD, United States.
authors.forename: Cyrille
authors.initials: C
authors.lastname: Amegashie
authors.affiliation: The Emmes Corporation, Rockville, MD, United States.
authors.forename: Abbie R
authors.initials: AR
authors.lastname: Bellamy
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D000956:Antigens, Viral / Q000032:analysis; D001769:Blood / Q000821:virology; D002648:Child; D003586:Cytomegalovirus Infections / Q000276:immunology / Q000517:prevention & control*; D022482:Cytomegalovirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D010919:Placebos / Q000008:administration & dosage; D016133:Polymerase Chain Reaction; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects; D014556:Urine / Q000821:virology; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology; D014759:Viral Envelope Proteins / Q000235:genetics / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D000956:Antigens, Viral; D022482:Cytomegalovirus Vaccines; D004279:DNA, Viral; C089950:MF59 oil emulsion; D010919:Placebos; D011136:Polysorbates; D022223:Vaccines, Subunit; D014614:Vaccines, Synthetic; D014759:Viral Envelope Proteins; C040495:glycoprotein B, Simplexvirus; D013185:Squalene
keywords: Adolescent; CMV gB; Cytomegalovirus; Vaccine