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Vaccine. 2007 Jun 11;25(24):4697-705. Epub 2007 Apr 18.

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

Author information

1
Department of Infectious Diseases and General Internal Medicine, CHU Sart-Tilman, University of Liège, Liège, Belgium. michel.moutschen@ulg.ac.be

Abstract

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).

PMID:
17485150
DOI:
10.1016/j.vaccine.2007.04.008
[Indexed for MEDLINE]

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