Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04

被引：72

作者：

Boland, G

Beran, J

Lievens, M

Sasadeusz, J

Dentico, P

Nothdurft, H

Zuckerman, JN

Genton, B

Steffen, R

Loutan, L

Van Hattum, J

Stoffel, M

机构：

[1] GSK Biol, B-1330 Rixensart, Belgium

[2] Univ Med Centrum Utrecht, Dept Gastroenterol, NL-3508 GA Utrecht, Netherlands

[3] Vaccinat & Travel Med Ctr, Hradec Kralove, Czech Republic

[4] Victorian Infect Dis Serv, Melbourne, Vic 3050, Australia

[5] Univ Bari, Ist Policattedra Clin Med & Malattie Infett, Cattedra Malattie Trop, I-1170124 Bari, Italy

[6] Univ Munich, Inst Trop Med, D-80802 Munich, Germany

[7] UCL Royal Free & Univ Coll, Sch Med, Acad Ctr Travel Med & Vaccines, London NW3 2PF, England

[8] Policlin Med Univ, CH-1011 Lausanne, Switzerland

[9] Univ Zurich, Inst Social & Prevent Med, CH-8006 Zurich, Switzerland

[10] Hop Univ Geneva, Unite Med Voyages & Migrat, CH-1211 Geneva 14, Switzerland

来源：

VACCINE | 2004年 / 23卷 / 03期

关键词：

safety; hepatitis B vaccine; adjuvant AS04;

D O I：

10.1016/j.vaccine.2004.06.006

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers greater than or equal to 15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine. (C) 2004 Elsevier Ltd. All rights reserved.

引用

页码：316 / 320

页数：5

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