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Vical had previously reported that the monovalent vaccine achieved potentially protective levels of antibody responses (H5 hemagglutination inhibition, or HI, titers of at least 40 and at least a four-fold increase from baseline) in at least 50% and up to 67% of evaluable subjects in a 100-subject Phase 1 trial. In the two monovalent vaccine cohorts receiving the highest H5 DNA dose (1 mg), 80% to 100% of the responders had sustained responses through Day 182.
Vical's monovalent vaccine contained a plasmid (a closed loop of DNA) encoding the hemagglutinin (HA) surface protein from the H5N1 influenza virus strain, A/Vietnam/1203/04. It was designed primarily to elicit antibody responses against the H5 protein but could elicit T-cell responses against H5 as well. Vical's trivalent vaccine contains the H5 plasmid plus separate plasmids encoding consensus sequences of two highly conserved influenza virus proteins: nucleoprotein (NP) and ion channel protein (M2). The trivalent vaccine was designed to elicit a combination of T-cell and antibody responses against all three proteins. Both vaccines were formulated with the company's Vaxfectin(R) adjuvant, which has demonstrated effectiveness with a variety of DNA vaccines in multiple animal models as well as dose-sparing and immune-enhancing ability in animals with a conventional seasonal influenza vaccine.
RapidResponse(TM) DNA Vaccine Manufacturing Update
New data presented at the current conference indicates that a single injection of a Vaxfectin(R)-formulated influenza vaccine produced by the company's RapidResponse(TM) manufacturing system prov
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