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

被引：117

作者：

Moutschen, Michel ^{[1
]}

Leonard, Philippe

Sokal, Etienne M.

Smets, Francoise

Haumont, Michele

Mazzu, Pasqualina

Bollen, Alex

Denamur, Francoise

Peeters, Pascal

Dubin, Gary

Denis, Martine

机构：

[1] Univ Liege, CHU Sart Tilman, Dept Infect Dis & Gen Internal Med, Liege, Belgium

[2] Univ Catholique Louvain, Clin Univ St Luc, Dept Paediat, B-1200 Brussels, Belgium

[3] Henogen, B-6041 Charleroi, Belgium

[4] GlaxoSmithKline Biol, B-1330 Rixensart, Belgium

来源：

VACCINE | 2007年 / 25卷 / 24期

关键词：

Epstein-Barr virus (EBV); vaccine; gp350;

D O I：

10.1016/j.vaccine.2007.04.008

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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.

引用

页码：4697 / 4705

页数：9