Abstract: This invention relates to a method for vaccination which is effective for eliciting an enhanced antigen-specific immune response in a mammal, fish or bird. The method is particularly effective for protecting a mammal, fish or bird from a disease including cancer, a disease associated with allergic inflammation, or an infectious disease. Also disclosed are therapeutic compositions useful in such a method.

Abstract: The present invention provides a cellular vaccine for therapeutic or prophylactic treatment of a pathological condition, the vaccine comprising or consisting of a population of CD 4+ T cells modified such that they contain an antigenic component, and/or a nucleic acid molecule encoding an antigenic component thereof, wherein the T cells are (a) activated, or capable of being activated, and (b) apoptotic, or capable or being made apoptotic. The invention further provides an adjuvant composition for use in a method of vaccination, the composition comprising or consisting of a population of T cells, wherein the T cells are (a) activated, or capable of being activated, and (b) apoptotic, or capable or being made apoptotic.

Abstract: The present invention includes compositions, methods and systems to isolate and characterize novel antiviral agents by contacting the antiviral agent with the F2F3 zinc fingers of a CPSF30 protein and an Influenza A NS1A protein; and determining whether the binding between the CPSF30 protein and the Influenza A NS1A protein is reduced.

Abstract: In certain aspects, the present invention provides methods for increasing the replication capacity of influenza viruses in hens' eggs and/or cell culture, recombinant and/or reassortant influenza viruses with increased replication capacity, and immunogenic and vaccine compositions comprising such recombinant and/or reassortant influenza viruses. In other aspects, the invention further provides nucleic acids encoding influenza genes associated with increased replication capacity, expression vectors comprising the nucleic acids of the invention, methods for making influenza viruses with increased replication capacity, and kits useful for practice of the methods.

Abstract: Methods and compositions for the optimization of production of influenza viruses suitable as influenza vaccines are provided.

Abstract: The instant invention provides methods for determining, predicting and characterizing the genetic variability of viruses, in particular, influenza. Accordingly, the invention provides methods for identifying virulent pathogens, genetic mutations within pathogens that are relevant to animal health, and methods and compositions for prophylactic or therapeutic intervention against such pathogens.

Abstract: The invention provides novel compositions comprising Imidazopyridine compounds. Also provided are methods of administering the compositions in an effective amount to enhance the immune response of a subject. Further provided are novel compositions and methods of administering the compositions in combination with (an)other agent(s).

Abstract: The present invention relates, in general, to attenuated negative-strand RNA viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. The invention also relates to the development and use of IFN-deficient systems for selection of such attenuated viruses. In particular, the invention relates to attenuated influenza viruses having modifications to the NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. The mutant viruses replicate in vivo but demonstrate reduced pathogenicity, and therefore are well suited for live virus vaccines, and pharmaceutical formulations.

Abstract: A method to prepare viruses with a mutant membrane protein gene, and viruses obtained by the method, are provided.

Abstract: An immunogenic composition comprising (i) a non-virion influenza virus antigen prepared from a virus grown in cell culture; and (ii) an adjuvant. Preferred adjuvants comprise oil-in-water emulsions.

Abstract: An influenza vaccine is administered by a multi-dose regimen, in which (i) a first dose is administered with an adjuvant and (ii) a later dose is administered either without an adjuvant or with a different adjuvant. Thus the invention provides the benefits of a two-dose regimen without also doubling the supply need for a given adjuvant.

Abstract: The invention relates to a method of producing a HPV polypeptides and/or an influenza virus H5 polypeptide in a plant comprising the steps of cloning a HPV gene; and/or an influenza virus H5 gene or nucleic acid encoding their functional equivalents into a vector adapted to target components present in the plant, infiltrating at least a portion of the plant with the vector or transforming plant tissue with the vector so as to transiently express the HPV polypeptides and/or an influenza virus H5 polypeptide, and/or to create a transgenic plant; and recovering the HPV polypeptides and/or an influenza virus H5 polypeptide expressed by the plant. The invention further relates to vectors, transgenic plants or parts thereof and the progeny of such plants used in or which come about as a result of the method.

Abstract: An influenza vaccine adjuvanted with a sub-micron oil-in-water emulsion elicits significantly higher immune responses in human pediatric populations. Compared to an existing unadjuvanted pediatric influenza vaccine, the adjuvanted vaccines provided herein can induce in children a longer persistence of high serum antibody titers and also longer seroconversion and seroprotection. The improvement in immune responses is seen for both influenza A virus and influenza B virus strains, but it is particularly marked for influenza B virus. Moreover, while the existing vaccine provides poor immunity in children after a single dose, the adjuvanted vaccine provides high seroprotection rates against the influenza A virus H3N2 subtype even after a single dose. Furthermore, the adjuvanted vaccine offers significantly better seroprotection against mismatched strains of influenza A virus.

Abstract: Vaccine containing a first vaccine, adjuvated with an oil-in-water emulsion comprising 5% squalene, 0.5% polysorbate 80 and 0.5% sorbitan trioleate in aqueous citrate buffer pH 6.5, and a nonadjuvated second vaccine as combination partners for the simultaneous, separate or phased application for immunization against viral, bacterial or parasitic infectious diseases.

Abstract: These vaccines target H5N1, H1, H3 and other subtypes of influenza and are designed to elicit neutralizing antibodies, as well as cellular immunity. The DNA vaccines express hemagglutinin (HA) or nucleoprotein (NP) proteins from influenza which are codon optimized and/or contain modifications to protease cleavage sites of HA which affect the normal function of the protein. Adenoviral constructs expressing the same inserts have been engineered for prime boost strategies. Protein-based vaccines based on protein production from insect or mammalian cells using foldon trimerization stabilization domains with or without cleavage sites to assist in purification of such proteins have been developed. Another embodiment of this invention is the work with HA pseudotyped lentiviral vectors which would be used to screen for neutralizing antibodies in patients and to screen for diagnostic and therapeutic antivirals such as monoclonal antibodies.

Abstract: Methods and compositions for the optimization and production of influenza viruses, e.g., ca influenza B strains, in eggs and host cells suitable as influenza vaccines are provided.

Abstract: Antigen and adjuvant components of an adjuvanted influenza vaccine are not mixed during manufacture, but are provided as separate components for extemporaneous mixing at the time of use, for example as a kit comprising (i) an antigen component, comprising an influenza virus antigen; and (ii) an adjuvant component, comprising an aluminium salt.

Abstract: The invention provides an isolated H3 equine influenza A virus, as well as methods of preparing and using the virus, and genes or proteins thereof.

Abstract: The invention provides compositions of influenza proteins, such as matrix and nucleoprotein, that are presented to an individual's immune system as multimeric displays to induce an immune response. The compositions are optionally associated with any type of immunomodulatory compound (IMC) comprising an immunostimulatory sequences (ISS). The invention further provides compositions of influenza matrix and nucleoproteins that can induce cellular and/or humoral immune response. The invention also provides methods of making and using these compositions, e.g., as a vaccine, for ameliorating symptoms associated with infection with influenza virus or for reducing the risk of infection with influenza virus.

Abstract: Codon-optimized nucleic acids encoding influenza polypeptides and uses of the nucleic acids and polypeptides for inducing immune responses are provided herein.

Abstract: Polypeptides, polynucleotides, methods, compositions, and vaccines comprising influenza hemagglutinin and neuraminidase variants are provided.

Abstract: The present invention relates to methods for treating a range of cancers, for example MAGE positive cancers, including, but not limited to melanoma and non-small cell lung cancer (NSCLC). The present invention relates to methods for treating cancer in the adjuvant (eg. post-operative) setting and the active disease setting.

Abstract: The present invention provides a polynucleotide adjuvant (PICKCa) composition and methods of use in eliciting an immune response, in particular a mucosal immune response. The polynucleotide adjuvant comprises of a polyriboinosinic-polyribocytidylic acid (PIC), at least one antibiotic and at least one positive ion. The present invention also provides an immunogenic composition comprising the polynucleotide adjuvant composition together with other immunogenic compositions such as an antigen (e.g., as in a vaccine) selected from viral, bacterial, fungal, parasitic and/or cancer antigens. The present invention further contemplates methods of use of such adjuvant compositions, particularly in eliciting an immune response, in particular a mucosal immune response to an antigenic compound.

Abstract: Influenza virus-like particles (VLPs) comprising the structural proteins HA, NA, M1 and M2 are described. VLPs are also generated containing M1 alone, as are VLPs with M1 and any one or two of HA, NA and M2. VLPs with HA from one influenza subtype and NA from a different influenza subtype are also described, as are VLPs in which a portion or all of HA or NA is replaced by a heterologous moiety not produced by influenza virus, so as to comprise chimeric VLPs.

Abstract: An aspect of the present invention is directed towards DNA plasmid vaccines capable of generating in a mammal an immune response against a plurality of influenza virus subtypes, comprising a DNA plasmid and a pharmaceutically acceptable excipient. The DNA plasmid is capable of expressing a consensus influenza antigen in a cell of the mammal in a quantity effective to elicit an immune response in the mammal, wherein the consensus influenza antigen comprises consensus hemagglutinin (HA), neuraminidase (NA), matrix protein, nucleoprotein, M2 ectodomain-nucleo-protein (M2e-NP), or a combination thereof. Preferably the consensus influenza antigen comprises HA, NA, M2e-NP, or a combination thereof. The DNA plasmid comprises a promoter operably linked to a coding sequence that encodes the consensus influenza antigen. Additionally, an aspect of the present invention includes methods of eliciting an immune response against a plurality of influenza virus subtypes in a mammal using the DNA plasmid vaccines provided.

Abstract: A microprojection array is provided, comprising an approximately planar base and a plurality of microprojections, wherein the array comprises a vaccine and a polymeric material. The array may have multiple layers. The vaccine may be placed in only one layer. In another embodiment of the invention, a method of preventing a disease is provided, comprising insertion into the skin of a patient an array of microprojections comprising a layer which comprises a vaccine for that disease and a polymer.

Abstract: The present invention is directed to enhancing the immune response of a human in need of protection against IV infection by administering in vivo, into a tissue of the human, at least one polynucleotide comprising one or more regions of nucleic acid encoding an IV protein or a fragment, a variant, or a derivative thereof. The present invention is further directed to enhancing the immune response of a human in need of protection against IV infection by administering, in vivo, into a tissue of the human, at least one IV protein or a fragment, a variant, or derivative thereof. The IV protein can be, for example, in purified form or can be an inactivated IV, such as those present in inactivated IV vaccines. The polynucleotide is incorporated into the cells of the human in vivo, and an immunologically effective amount of an immunogenic epitope of an IV, or a fragment, variant, or derivative thereof is produced in vivo.

Abstract: A method of making a vaccine using animal derived component free (ADCF) cell culture technology, including the steps of attaching ADCF-adapted cells to a microcarrier including an attachment mechanism for attaching filipodia of the cells, the microcarrier being in a culture, growing the cells in ADCF maintenance media, infecting the cells with vaccine media, producing virus within the cells, and harvesting the virus. A vaccine produced by the above method in a pharmaceutically acceptable carrier. A vaccine production structure of ADCF-adapted cells removably attached to microcarrier beads including an attachment mechanism for attaching filipodia of the cells.

Abstract: The present invention provides a pharmaceutical composition with an adjuvant based on an apathogenic virus, together with an antigen. The adjuvant has a natural or through genetical engineering no, reduced or altered expression of an endogenous interferon antagonist or endogenous immune suppressor.

Abstract: Polypeptides, polynucleotides, methods, compositions, and vaccines comprising (avian pandemic) influenza hemagglutinin and neuraminidase variants are provided.

Abstract: The invention discloses polypeptides encoded by an alternative reading frame of a pathogenic virus, which polypeptides—start with a methionine amino acid residue,—comprise an antigenic determinant and—comprise more than 7 amino acid residues and fragments of said polypeptides comprising more than 7 amino acids.

Abstract: The present invention provides multiple antigenic agents compositions and the use thereof to prevent or treat viral infections.

Abstract: The present invention generally relates to the field of immunology and provides immunoprotective compositions and methods for preparing such compositions from transgenic plant cells. The present invention also relates to the field of protein production (e.g., the recombinant production of enzymes, toxins, cell receptors, ligands, signal transducing agents, cytokines, or other proteins expressed in transgenic plant cell culture) and provides compositions comprising these proteins.

Abstract: The present invention provides a virosome comprising a virosomal membrane comprising at least one lipid and envelope proteins of an enveloped virus and of the virosome and attached to said envelope proteins. Furthermore, the invention provides a vaccine comprising the virosome of the invention and, a method for the production of a virosome of the invention. Moreover, the invention provides a use of a virosome of the invention for the preparation of a vaccine, e.g. for the prevention or alleviation of a disease related to an HBV infection, and a method for the vaccination of a subject.

Abstract: Methods and compositions for the optimization and production of influenza viruses, e.g., ca influenza B strains, in eggs and host cells suitable as influenza vaccines are provided.

Abstract: The invention relates to a method for producing flu virus according to which: a) immunizing a hen by administering a flu vaccine to the hen, b) triggering embryogenesis in one or more eggs of the immunized hen, c) infecting the one or more embryonated eggs by inoculating a flu virus into the allantoic cavity of the eggs, d) incubating the one or more infected embryonated eggs under temperature and humidity conditions that allow replication of the virus, and e) harvesting the allantoic fluid of the one or more incubated eggs containing the virus.

Abstract: Attenuated influenza virus variants comprising substitutions in NS1 that interfere with viral replication and phosphatidylinositol 3-kinase activation are described. NS1 variant polypeptides, polynucleotides encoding NS1 variant polypeptides, a reverse genetics system for producing attenuated influenza virus NS1 variants, immunogenic compositions comprising live attenuated influenza virus NS1 variants, methods of stimulating an immune response against influenza virus, methods of interfering with influenza virus replication, and methods of treating and preventing influenza virus infection are described.

Abstract: The recombinant live vaccine comprises a viral vector incorporating and expressing in vivo a heterologous nucleotide sequence, preferably a gene of a pathogenic agent, and at least one adjuvant compound chosen from the acrylic or methacrylic polymers and the copolymers of maleic anhydride and an alkenyl derivative. It is in particular a polymer of acrylic or methacrylic acid cross-linked with a polyalkenyl ether of a sugar or polyalcohol (carbomer), in particular cross-linked with an allyl sucrose or with allylpentaerythritol. It may also be a copolymer of maleic anhydride and ethylene cross-linked, for example, with divinyl ether.

Abstract: A method to prepare recombinant influenza viruses comprising a mutant M2 protein which has a deletion of two or more residues in the cytoplasmic tail and is attenuated in vivo, is provided, as well the resulting virus and vaccines with the virus.

Abstract: A vaccination method utilizes a pharmaceutical combination for enhancing vaccine effectiveness. The method utilizes an immune response-triggering vaccine capable of stimulating production in an immunodefficicent animal of antibodies to a disease-causing agent foreign to the animal. As an adjuvant, a vaccine effectiveness-enhancing amount of an immunomodulator compound is administered, which enhances production and affinity of the antibodies in the animal, in response to the vaccine.

Abstract: The present invention provides novel methods to identify polypeptide ligands for Toll-like Receptors (TLRs), such as TLR2, TLR4 and TLR5. The method involves the use of phage display technology in an iterative biopanning procedure. The invention also provides polypeptide TLR ligands identified by the methods of the invention. In preferred embodiments, the polypeptide TLR ligands so identified modulate TLR signaling and thereby regulate the Innate Immune Response. The invention also provides vaccines comprising a polypeptide TLR ligand identified by the methods of the invention and an antigen. The invention also provides methods of modulating TLR signaling using the polypeptide TLR ligands and vaccines of the invention.

Abstract: The present invention provides a method for the manufacture of a preparation comprising virus antigens comprising a) inoculation of cells with infectious virus in a fluid, b) propagation of said virus in said cells, c) collecting said propagated virus, d) inactivating said collected virus, and e) treating said inactivated virus with a detergent, resulting in a preparation comprising viral antigens.

Abstract: The present invention relates to a method to introduce a nucleic acid molecule into a fetid by administration of a nucleic acid-cationic lipid complex composition. The method includes the step of administering to the felid, by a parenteral route, a nucleic acid-cationic lipid complex to elicit and/or enhance an immune response. In one embodiment, this method enhances the immune response in a fetid compared to a method in which a naked DNA vaccine is administered to a felid. Also provided is a method to deliver a nucleic acid to a felid. This method comprises parenterally administering to the fetid a composition that includes a nucleic acid molecule complexed with a cationic lipid.

Abstract: This disclosure is directed, inter alia, to polynucleotides, polypeptides, vectors, cells and compositions comprising the same, and their use in affecting viral pathogenesis, in particular for influenza viral infection.

Abstract: The present invention relates to the identification of host cell proteins that interact with viral proteins required for virus replication, and high throughput assays to identify compounds that interfere with the specific interaction between the viral and host cell protein. Interfering compounds that inhibit viral replication can be used therapeutically to treat viral infection. The invention is based, in part, on the Applicants' discovery of novel interactions between proteins of the influenza virus and a human host cell proteins. One of these host cell proteins, referred to herein as NPI-1, interacts with influenza virus protein NP, and may be an accessory protein required for replication of influenza virus. Another of these host cell proteins, referred to herein as NS1I-1, interacts with influenza virus protein NS1. Compounds that interfere with the binding of the host cell and viral proteins, and inhibit viral replication can be useful for treating viral infection in vivo.

Abstract: The present invention relates, in general, to attenuated negative-strand RNA viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. The invention also relates to the development and use of IFN-deficient systems for selection of such attenuated viruses. In particular, the invention relates to attenuated influenza viruses having modifications to the NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. The mutant viruses replicate in vivo but demonstrate reduced pathogenicity, and therefore are well suited for live virus vaccines, and pharmaceutical formulations.

Abstract: The present invention provides a composition comprising an AP205 virus like particle (VLP) and an antigen. The invention also provides a process for producing an antigen or antigenic determinant bound to AP205 VLP. AP205 VLP bound to an antigen is useful in the production of compositions for inducing immune responses that are useful for the prevention or treatment of diseases, disorders or conditions including infectious diseases, allergies, cancer, drug addiction, poisoning and to efficiently induce self-specific immune responses, in particular antibody responses.

Abstract: The invention relates to a simple and efficient process for isolating viruses from various sources and for producing live attenuated influenza vaccines in a serum-free Vero cell culture under conditions where alterations in the surface antigens of the virus due to adpative selection are minimized or prevented. The process does not require purification of the virus-containing supernatant harvested from the cell culture nor post-incubation treatment of the viruses for HA activation. The invention further relates to influenza A and B master strain candidates and to vaccines made thereof.

Abstract: This invention provides a dry powder composition for poultry vaccination via inhalation comprising an effective amount of a poultry vaccine agent, and a supporting amount of carriers for said poultry vaccine agent, said carriers comprising a combination of a reducing or non-reducing sugar and a biocompatible polymer, said dry powder composition being in the form of particles having an average particle size from 2 to 30 ?m and a particle size polydispersity from 1.1 to 4.0. This invention also relates to a method for producing said dry powder compositions and a system for vaccination of poultry by inhalation.

Abstract: A preparation in powder form for administration through mucosa, comprising a medicine of high molecular weight and a cationic polymer is disclosed. By adding a cationic polymer (in particular, a copolymer of aminoalkylmethacrylate or polyvinyl acetal diethylaminoacetate) or a cationic polymer plus a viscous polymer to a medicine of high molecular weight for producing a preparation in powder form, it is possible to achieve effective absorption of the medicine of high molecular weight through mucosa.