title: Recombinant gp350 vaccine for infectious mononucleosis: a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults.
abstract: BACKGROUND
  To date, there is no commercially available vaccine to prevent infectious mononucleosis, a disease frequently induced by Epstein-Barr virus (EBV) infection in adolescents or adults devoid of preexisting immunity to the virus.
  
  
  METHODS
  A total of 181 EBV-seronegative, healthy, young adult volunteers were randomized in a double-blind fashion to receive either placebo or a recombinant EBV subunit glycoprotein 350 (gp350)/aluminum hydroxide and 3-O-desacyl-4'-monophosphoryl lipid A (AS04) candidate vaccine in a 3-dose regimen.
  
  
  RESULTS
  The vaccine had demonstrable efficacy (mean efficacy rate, 78.0% [95% confidence interval {CI}, 1.0%-96.0%]) in preventing the development of infectious mononucleosis induced by EBV infection, but it had no efficacy in preventing asymptomatic EBV infection. One month after receipt of the final dose of gp350 vaccine, 98.7% of subjects showed seroconversion to anti-gp350 antibodies (95% CI, 85.5%-97.9%), and they remained anti-gp350 antibody positive for >18 months. Furthermore, there were no concerns regarding the safety or reactogenicity of the gp350/AS04 vaccine.
  
  
  CONCLUSIONS
  These data support the clinical feasibility of using an EBV vaccine to prevent infectious mononucleosis.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00430534.
authors.affiliation: Université Catholique de Louvain, Cliniques Universitaires St-Luc, Avenue Hippocrate 10/1301, 1200 Brussels, Belgium. sokal@pedi.ucl.ac.be
authors.forename: Etienne M
authors.initials: EM
authors.lastname: Sokal
authors.forename: Karel
authors.initials: K
authors.lastname: Hoppenbrouwers
authors.forename: Corinne
authors.initials: C
authors.lastname: Vandermeulen
authors.forename: Michel
authors.initials: M
authors.lastname: Moutschen
authors.forename: Philippe
authors.initials: P
authors.lastname: Léonard
authors.forename: Andre
authors.initials: A
authors.lastname: Moreels
authors.forename: Michèle
authors.initials: M
authors.lastname: Haumont
authors.forename: Alex
authors.initials: A
authors.lastname: Bollen
authors.forename: Françoise
authors.initials: F
authors.lastname: Smets
authors.forename: Martine
authors.initials: M
authors.lastname: Denis
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D036022:Capsid Proteins / Q000276:immunology*; D006224:Cricetinae; D003412:Cricetulus; D004311:Double-Blind Method; D005260:Female; D004854:Herpesvirus 4, Human / Q000235:genetics / Q000276:immunology*; D022283:Herpesvirus Vaccines / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use*; D006801:Humans; D007115:Immunization Schedule; D007244:Infectious Mononucleosis / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D019444:Vaccines, DNA / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use*; D022223:Vaccines, Subunit / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use; D014763:Viral Matrix Proteins / Q000235:genetics / Q000276:immunology*
chemical_list: D036022:Capsid Proteins; C037662:EBV-associated membrane antigen, Epstein-Barr virus; D022283:Herpesvirus Vaccines; D019444:Vaccines, DNA; D022223:Vaccines, Subunit; D014763:Viral Matrix Proteins