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

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).

journal_name

Vaccine

journal_title

Vaccine

authors

Moutschen M,Léonard P,Sokal EM,Smets F,Haumont M,Mazzu P,Bollen A,Denamur F,Peeters P,Dubin G,Denis M

doi

10.1016/j.vaccine.2007.04.008

subject

Has Abstract

pub_date

2007-06-11 00:00:00

pages

4697-705

issue

24

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(07)00418-5

journal_volume

25

pub_type

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