Immunogenicity and tolerability of an AS03A-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adults

被引：81

作者：

Chu, Daniel Wai-Sing ^{[1
]}

Hwang, Shinn-Jang ^{[2
,3
]}

Lim, Fong Seng ^{[4
]}

Oh, Helen May Lin ^{[5
]}

Thongcharoen, Prasert ^{[6
]}

Yang, Pan-Chyr ^{[7
]}

Bock, Hans L. ^{[8
]}

Drame, Mamadou ^{[8
]}

Gillard, Paul ^{[8
]}

Hutagalung, Yanee ^{[8
]}

Tang, Haiwen ^{[8
]}

Teoh, Yee Leong ^{[8
]}

Ballou, Ripley W. ^{[8
,9
]}

机构：

[1] Univ Hong Kong, Queen Mary Hosp, Dept Med, Hong Kong, Hong Kong, Peoples R China

[2] Taipei Vet Gen Hosp, Taipei, Taiwan

[3] Natl Yang Ming Univ, Taipei 112, Taiwan

[4] Natl Healthcare Grp Polyclin Choa Chu Kang, Singapore, Singapore

[5] Changi Gen Hosp, Singapore, Singapore

[6] Siriraj Hosp, Bangkok, Thailand

[7] Natl Taiwan Univ Hosp, Taipei, Taiwan

[8] GlaxoSmithKline Biol, Rixensart, Belgium

[9] Bill & Melinda Gates Fdn, Seattle, WA 98102 USA

来源：

VACCINE | 2009年 / 27卷 / 52期

关键词：

Influenza; Vaccine; H5N1; virus; CROSS-REACTIVE IMMUNITY; PANDEMIC INFLUENZA; H5N1; EVOLUTION; SAFETY; TRIAL;

D O I：

10.1016/j.vaccine.2009.07.102

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 immunogenicity and lot-to-lot consistency of an AS03-adjuvanted H5N1 vaccine were evaluated in 1206 Asian adults, randomised to receive two doses of adjuvanted (3.75 mu g haemagglutinin) or diluent-mixed vaccines, 21 days apart. Post-Dose 2, 96.0% of vaccinees in the H5N1-AS03 group demonstrated a four-fold increase in neutralising antibody titres against the vaccine strain A/Vietnam/1194/2004 and 91.4% against strain A/Indonesia/0512005. Haemagglutination-inhibiting antibodies (titre >= 1:40) against A/Vietnam/1194/2004 and A/Indonesia/05/2005 strains were observed in 94.3% and 50.2% of subjects, respectively. Lot-to-lot consistency of the AS03-adjuvanted vaccine combinations was demonstrated. The AS03-adjuvanted vaccine was well tolerated, induced a high frequency of immune responses to the vaccine strain, allowed antigen sparing and promoted cross-clade immunity. These characteristics make it suitable for presumptive use if an H5N1 pandemic were considered to be imminent. (C) 2009 Elsevier Ltd. All rights reserved.

引用

页码：7428 / 7435

页数：8

共 21 条

[1]

[Anonymous], 2007, GUID IND CLIN DAT NE

[2] Cross-Protection against Lethal H5N1 Challenge in Ferrets with an Adjuvanted Pandemic Influenza Vaccine [J].

Baras, Benoit ;

Stittelaar, Koert J. ;

Simon, James H. ;

Thoolen, Robert J. M. M. ;

Mossman, Sally P. ;

Pistoor, Frank H. M. ;

van Amerongen, Geert ;

Wettendorff, Martine A. ;

Hanon, Emmanuel ;

Osterhaus, Albert D. M. E. .

PLOS ONE, 2008, 3 (01)

[3]

*EUR COMM HUM MED, 2007, EMEACHMPVWP263499200

[4]

European committee for proprietary medicinal products, 2004, CPMPVEG471703 EUR CO

[5] Strategies for mitigating an influenza pandemic [J].

Ferguson, Neil M. ;

Cummings, Derek A. T. ;

Fraser, Christophe ;

Cajka, James C. ;

Cooley, Philip C. ;

Burke, Donald S. .

NATURE, 2006, 442 (7101) :448-452

[6] Mitigation strategies for pandemic influenza in the United States [J].

Germann, TC ;

Kadau, K ;

Longini, IM ;

Macken, CA .

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 2006, 103 (15) :5935-5940

[7] Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvanted Clade 1 rH5N1 Pandemic Influenza Vaccine [J].

Leroux-Roels, Isabel ;

Bernhard, Roger ;

Gerard, Pascal ;

Drame, Mamadou ;

Hanon, Emmanuel ;

Leroux-Roels, Geert .

PLOS ONE, 2008, 3 (02)

[8] Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine:: a randomised controlled trial [J].

Leroux-Roels, Isabel ;

Borkowski, Astrid ;

Vanwolleghem, Thomas ;

Drame, Mamadou ;

Clement, Frederic ;

Hons, Eliane ;

Devaster, Jeanne-Marie ;

Leroux-Roels, Geert .

LANCET, 2007, 370 (9587) :580-589

[9] Origin and evolution of the 1918 "Spanish" influenza virus hemagglutinin gene [J].

Reid, AH ;

Fanning, TG ;

Hultin, JV ;

Taubenberger, JK .

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 1999, 96 (04) :1651-1656

[10] Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial [J].

Rumke, Hans C. ;

Bayas, Jos-Maria ;

de Juanes, Jose-Ramon ;

Caso, Covadonga ;

Richardus, Jan Hendrik ;

Campins, Magda ;

Rombo, Lars ;

Duval, Xavier ;

Romanenko, Viktor ;

Schwarz, Tino F. ;

Fassakhov, Rustem ;

Abad-Santos, Francisco ;

von Sonnenburg, Frank ;

Drame, Mamadou ;

Sanger, Roland ;

Balloun, W. Ripley .

VACCINE, 2008, 26 (19) :2378-2388

← 1 2 3 →