The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, and Medicago Inc., a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and virus-like particles (VLPs), announce that they will be presenting positive interim Phase I clinical results for their H5N1 avian influenza VLP vaccine candidate at the World Vaccine Congress. The meeting is being held in Washington, D.C., April 16-18, 2013.
Dr. Steven Reed, founder, president and chief scientific officer for IDRI, and Dr. Brian Ward, professor of medicine and microbiology at McGill University and a member of Medicago's scientific advisory committee, will be presenting at the World Vaccine Congress on April 17, 2013, at 2:35 p.m. EDT. The presentation, "H5N1 Phase 1 clinical trial combining Medicago's VLP vaccine with IDRI's GLA adjuvant formulation," will discuss preliminary safety and immunology data from the ongoing H5N1 vaccine clinical trial.
The Phase I clinical trial, which commenced in September 2012, enrolled 100 healthy adult volunteers, aged 18-49 years, at three locations in the U.S., testing for safety and immune response. The vaccine was also tested in comparison to Medicago's H5N1 vaccine with alum. The trial is funded by a multi-million dollar grant IDRI received from the Defense Advanced Research Projects Agency (DARPA), a division of the United States Department of Defense, to investigate the safety and immunogenicity of a novel adjuvant with a Nicotiana benthamiana produced vaccine candidate. Each study participant in the trial received two doses of a given formulation in order to collect and compare data.
The trial focused on evaluating the safety and immunogenicity of the H5N1 vaccine, combined with IDRI's Glucopyranosyl Lipid A ("GLA") adjuvant, which 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.
"This trial is an important step toward development of an influenza vaccine that could be rapidly and widely administered in case of a pandemic outbreak," says Reed.
According to the Centers for Disease Control and Prevention (CDC), the highly pathogenic avian influenza A (H5N1) virus is a deadly virus that occurs mainly in birds including domestic poultry. Though relatively rare, sporadic human infections with this virus have occurred and caused serious illness and death. Because of the unpredictability of pandemic flu, efforts are being made to create and stockpile a vaccine to combat H5N1 that reduces the amount of vaccine needed per person and can be easily administered.
The H5N1 vaccine candidate includes IDRI's GLA adjuvant, which has been exclusively licensed to Immune Design Corp. for certain fields, including influenza, and is produced in Medicago's plant-based expression system, which is speedier than the traditional route of producing flu vaccines in eggs. The adjuvant system has been combined with Medicago's vaccine candidate and other recombinant protein antigens to elicit both humoral and cell-mediated immune responses associated with protection in pathogenic animal challenge models. In animal studies, GLA has also been shown to expand the cross reactivity of antibodies induced by the H5N1 vaccine to other potential pandemic influenza strains such as H2N2.