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IDRI and Medicago report positive results for Phase I clinical trial for an H5N1 vaccine
Date:4/17/2013

order to collect and compare data.

The trial focused on evaluating the safety and immunogenicity of the H5N1 vaccine, combined with IDRI's GLA adjuvant, which has been exclusively licensed to Immune Design Corp for certain fields, including influenza. The vaccine was administered intramuscularly or intradermally. The intradermal route of administration was also tested in comparison with intramuscular delivery, using an FDA licensed device (MicronJet600, NanoPass Technologies) as the micro-needle device was previously shown in seasonal and pandemic flu tests to allow significant dose sparing. This study is among the first to test intradermal adjuvants and is the first time GLA has been tested intradermally.

Safety and Immunogenicity Results

The H5N1 vaccine candidate has been tested in over 300 healthy volunteers to date, none of which have experienced any serious adverse reactions. The H5N1 vaccine candidate was found to be safe and well tolerated. As planned in the clinical design, monitoring of adverse events will continue for one year.

All three configurations of adjuvant and route of administration for 20ug of the H5N1 vaccine candidate induced a solid immune response against the H5N1 viral strain that exceeded the CHMP immunogenicity criteria for licensure of influenza vaccines which are 40% seroconversion, 70% seroprotection and 2.5x geometric mean increase (GMI). For a 20ug dose of the H5N1 vaccine plus; 2.5ug GLA-AF administered intradermally (ID), 2.5ug GLA-AF delivered Intramuscularly (IM) and 0.5ug alum formulation administered IM, a four-fold increase in HI titers (seroconversion) was observed in 65.0%, 80.0% and 83.3% of subjects, respectively. The seroprotection rate was 70.0%, 85.0% and 89.9%, respectively. The GMI was 10.3x, 8.7x, and 11.4x, respectively.

About H5N1

According to the Centers for Disease Control and Prevention, the highly pathogenic avian influenza A (H5N1) virus is a
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Contact: Lee Schoentrup
lee.schoentrup@idri.org
206-858-6064
Infectious Disease Research Institute
Source:Eurekalert

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