Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial

作者：Jiřı́ Beran, Arvydas Ambrozaitis, Alvydas Pranas Laiškonis, Narseta Mickuvienė, Patrick Bacart, Yvan Calozet, Etienne Demanet, Stéphane Heijmans, Paul Van Belle, Françoise Weber, Camille Salamand · 发表于：BMC Medicine · 年份：2009 · DOI：10.1186/1741-7015-7-13 · 被引用次数：101 · 研究领域：Immunotherapy and Immune Responses、Influenza Virus Research Studies、Lymphadenopathy Diagnosis and Analysis

BACKGROUND: Intradermal vaccination provides direct and potentially more efficient access to the immune system via specialised dendritic cells and draining lymphatic vessels. We investigated the immunogenicity and safety during 3 successive years of different dosages of a trivalent, inactivated, split-virion vaccine against seasonal influenza given intradermally using a microinjection system compared with an intramuscular control vaccine. METHODS: In a randomised, partially blinded, controlled study, healthy volunteers (1150 aged 18 to 57 years at enrollment) received three annual vaccinations of intradermal or intramuscular vaccine. In Year 1, subjects were randomised to one of three groups: 3 microg or 6 microg haemagglutinin/strain/dose of inactivated influenza vaccine intradermally, or a licensed inactivated influenza vaccine intramuscularly containing 15 microg/strain/dose. In Year 2 subjects were randomised again to one of two groups: 9 microg/strain/dose intradermally or 15 microg intramuscularly. In Year 3 subjects were randomised a third time to one of two groups: 9 microg intradermally or 15 microg intramuscularly. Randomisation lists in Year 1 were stratified for site. Randomisation lists in Years 2 and 3 were stratified for site and by vaccine received in previous years to ensure the inclusion of a comparable number of subjects in a vaccine group at each centre each year. Immunogenicity was assessed 21 days after each vaccination. Safety was assessed throughout th...