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

J Infect Dis. 2007 Dec 15;196(12):1749-53. doi: 10.1086/523813.


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.

Conclusion: These data support the clinical feasibility of using an EBV vaccine to prevent infectious mononucleosis.

Trial registration: identifier: NCT00430534.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Animals
  • Capsid Proteins / immunology*
  • Cricetinae
  • Cricetulus
  • Double-Blind Method
  • Female
  • Herpesvirus 4, Human / genetics
  • Herpesvirus 4, Human / immunology*
  • Herpesvirus Vaccines / genetics
  • Herpesvirus Vaccines / immunology
  • Herpesvirus Vaccines / therapeutic use*
  • Humans
  • Immunization Schedule
  • Infectious Mononucleosis / immunology
  • Infectious Mononucleosis / prevention & control*
  • Infectious Mononucleosis / virology
  • Male
  • Vaccines, DNA / genetics
  • Vaccines, DNA / immunology
  • Vaccines, DNA / therapeutic use*
  • Vaccines, Subunit / genetics
  • Vaccines, Subunit / immunology
  • Vaccines, Subunit / therapeutic use
  • Viral Matrix Proteins / genetics
  • Viral Matrix Proteins / immunology*


  • Capsid Proteins
  • EBV-associated membrane antigen, Epstein-Barr virus
  • Herpesvirus Vaccines
  • Vaccines, DNA
  • Vaccines, Subunit
  • Viral Matrix Proteins

Associated data