Seasonal influenza vaccine delivered by intradermal microinjection: A randomised controlled safety and immunogenicity trial in adults

被引:97
作者
Leroux-Roels, Isabel [1 ]
Vets, Eva [2 ]
Freese, Ralf [3 ]
Seiberling, Michael [4 ]
Weber, Francoise [5 ]
Salamand, Camille [5 ]
Leroux-Roels, Geert [1 ]
机构
[1] Ghent Univ & Hosp, Ctr Vaccinol, B-9000 Ghent, Belgium
[2] SGS Biopharma, Res Univ Stuivenberg, Antwerp, Belgium
[3] Univ Med Ctr Hamburg Eppendorf, CTC N, MediGate GmbH, Clin Trial Ctr, Hamburg, Germany
[4] Swiss Pharma Contract, Allschwil, Switzerland
[5] Sanofi Pasteur, Lyon, France
关键词
Influenza vaccine; Intradermal; Microinjection; Immune response; Haemagglutination inhibition;
D O I
10.1016/j.vaccine.2008.09.078
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Influenza vaccines remain largely underused. A promising alternative to Current intramuscular vaccines is a trivalent inactivated influenza vaccine (TIV) delivered using a microinjection system to offer a less invasive and possibly more acceptable vaccination. A phase 11, multicentre, randomised open-label study in 978 healthy adults (18-57 years) evaluated the immunogenicity and safety of intradermal TIV. Subjects received a 0.1 ml injection of intradermal TIV, containing 9 mu g of haemagglutinin (HA) per strain (it = 588) or a conventional 0.5 ml intramuscular vaccine (15 mu g of HA/strain: n = 390). Intradermal,11 TIV induced non-inferior humoral immune responses against all three strains and superior responses against both A strains (H1N1, H3N2) compared with the control. Both vaccines were well tolerated. (C) 2008 Elsevier Ltd. All rights reserved.
引用
收藏
页码:6614 / 6619
页数:6
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