Title: Recombinant gp350 vaccine for infectious mononucleosis: a phase 2 randomised, double blind, placebo-controlled trial to evaluate the safety, immunogenicity and efficacy of an Epstein-Barr virus vaccine in healthy young adults
Authors: Sokal, EM ×
Hoppenbrouwers, Karel
Vandermeulen, Corinne
Moutschen, M
Léonard, P
Moreels, A
Haumont, M
Bollen, A
Smets, F
Denis, M #
Issue Date: Dec-2007
Publisher: Published by the University of Chicago Press for the Infectious Diseases Society of America
Series Title: The Journal of Infectious Diseases vol:196 pages:1749-1753
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 for18 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.
ISSN: 0022-1899
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Youth Health (-)
Environment and Health - miscellaneous
× corresponding author
# (joint) last author

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