ORBi: Moutschen Michel - Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-Barr virus vaccine in healthy adults

Reference : Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-...


	Document type :	Scientific journals : Article
	Discipline(s) :	Life sciences : Veterinary medicine & animal health Human health sciences : Laboratory medicine & medical technology Human health sciences : Immunology & infectious disease
	To cite this reference:	http://hdl.handle.net/2268/71466

Title :	Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-Barr virus vaccine in healthy adults
Language :	English
Author, co-author :	Moutschen, Michel [Université de Liège - ULg > Département des sciences cliniques > Immunopathologie - Transplantation]
	Leonard, Philippe [Centre Hospitalier Universitaire de Liège - CHU > > Maladies infectieuses et médecine interne générale >]
	Sokal, E. M. [> > > >]
	Smets, F. [> > > >]
	Haumont, M. [> > > >]
	Mazzu, P. [> > > >]
	Bollen, A. [> > > >]
	Denamur, F. [> > > >]
	Peeters, P. [> > > >]
	Dubin, G. [> > > >]
	Denis, M. [> > > >]
Publication date :	11-Jun-2007
Journal title :	Vaccine
Publisher :	Elsevier Sci Ltd
Volume :	25
Issue/season :	24
Pages :	4697-4705
Audience :	International
ISSN :	0264-410X
City :	Oxford
Keywords :	[en] Epstein-Barr virus (EBV) ; vaccine ; gp350
Abstract :	[en] Two double-blind randomised controlled studies (phase I and I/II) were performed to assess for the first time the safety and immunogenicity of a recombinant subunit gp350 Epstein-Barr virus (EBV) vaccine in 148 healthy adult volunteers. All candidate vaccine formulations had a good safety profile and were well tolerated, with the incidence of solicited and unsolicited symptoms within a clinically acceptable range. One serious adverse event was reported in the phase I trial which was considered to be of suspected relationship to vaccination. The gp350 vaccine formulations were immunogenic and induced gp350-specific antibody responses (including neutralising antibodies). (c) 2007 Elsevier Ltd. All rights reserved.
Permalink :	http://hdl.handle.net/2268/71466
DOI :	10.1016/j.vaccine.2007.04.008

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