Evaluation of a virosomal H5N1 vaccine formulated with Matrix M™ adjuvant in a phase I clinical trial

被引：84

作者：

Cox, Rebecca J. ^{[1
,2
]}

Pedersen, Gabriel ^{[2
]}

Madhun, Abdullah S. ^{[2
]}

Svindland, Signe ^{[2
]}

Saevik, Marianne ^{[3
]}

Breakwell, Lucy ^{[4
]}

Hoschler, Katja ^{[4
]}

Willemsen, Marieke

Campitelli, Laura ^{[5
]}

Nostbakken, Jane Kristin ^{[2
]}

Weverling, Gerrit Jan

Klap, Jaco

McCullough, Kenneth C. ^{[6
]}

Zambon, Maria ^{[4
]}

Kompier, Ronald

Sjursen, Haakon ^{[3
,7
]}

机构：

[1] Univ Bergen, Haukeland Univ Hosp, Dept Res & Dev, Influenza Ctr,Gade Inst, N-5021 Bergen, Norway

[2] Univ Bergen, Gade Inst, Influenza Ctr, N-5021 Bergen, Norway

[3] Haukeland Hosp, Infect Dis Unit, N-5021 Bergen, Norway

[4] HPA, Resp Unit, London, England

[5] Ist Super Sanita, Natl Influenza Ctr, Dept Infect Parasit & Immune Mediated Dis, I-00161 Rome, Italy

[6] IVI, CH-3147 Mittelhausern, Switzerland

[7] Univ Bergen, Inst Med, N-5021 Bergen, Norway

来源：

VACCINE | 2011年 / 29卷 / 45期

关键词：

Matrix M; Influenza H5N1; Cross-reactivity; Antibody response; HI; MN; SRH; INFLUENZA H5N1; WHOLE-VIRUS; MF59-ADJUVANTED INFLUENZA; CROSS-REACTIVITY; SAFETY; IMMUNOGENICITY; CANDIDATE; ANTIBODY; MONOVALENT; ANTIGENICITY;

D O I：

10.1016/j.vaccine.2011.08.042

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 avian influenza H5 virus epizootic continues to cause zoonosis with human fatalities, highlighting the continued need for pandemic preparedness against this subtype. This study evaluated the tolerability and immunogenicity of a Matrix M (TM) adjuvanted virosomal H5N1 vaccine in a phase I clinical trial. Sixty healthy adults were vaccinated intramuscularly with two doses of influenza H5N1 (NIBRG-14) virosomal vaccine alone (30 mu g haemagglutinin (HA)) or 1.5, 7.5 or 30 mu g HA formulated with 50 mu g Matrix M (TM) adjuvant. The antibody response was analysed by haemagglutination inhibition (HI), microneutralisation (MN) and single radial haemolysis (SRH) assays. The vaccine was well tolerated in all groups but injection site pain was more frequently observed in the Matrix M (TM) adjuvanted groups. The vaccine elicited homologous and heterologous H5N1-specific antibody responses and the Matrix M (TM) adjuvanted formulations met all the EU regulatory criteria. In conclusion, Matrix M (TM) adjuvant was well tolerated and augmented the antibody response allowing considerable dose sparing down to 1.5 mu g HA. (C) 2011 Elsevier Ltd. All rights reserved.

引用

页码：8049 / 8059

页数：11

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