Abstract: The present disclosure relates to multivalent immunogen compositions for treating or preventing diseases or disorders in canines caused by or associated with one or more of canine distemper virus, canine adenovirus (type 1 or type 2), canine parainfluenza virus, canine parvovirus, Leptospira canicola, Leptospira icterohaemorrhagiae, Leptospira grippotyphosa, Leptospira pomona, Leptospira bratislava, Leptospira hardjo, Leptospira autumnalis, Leptospira australis, Leptospira hebdomadis, and Bordetella bronchiseptica. The Leptospira compositions can also be used for treating or preventing leptospirosis diseases or disorders in canine, swine, and bovine.

Abstract: The present invention provides novel canine pol I regulatory nucleic acid sequences useful for the expression of nucleic acid sequences in canine cells such as MDCK cells. The invention further provides expression vectors and cells comprising such nucleic acids as well as methods of using such nucleic acids to make influenza viruses, including infectious influenza viruses.

Abstract: A nucleic acid construct comprising a chimeric promoter sequence and a cloning site for insertion of a coding sequence in operable linkage with the chimeric promoter, wherein the chimeric promoter sequence comprises: (a) a Hcmv immediate early promoter sequence; (b) exon 1 and at least a part of exon 2 of the hCMV major immediate early gene; and (c) a heterologous intron provided in place of the intron A region of the hCMV major immediate early gene.

Abstract: The present invention provides methods of differentiating the infectivity and lethality of isolates of influenza virus and provides compounds for diagnosing, preventing, and treating outbreaks of influenza virus including compounds for diagnosing, preventing, and treating across different strains of influenza virus.

Abstract: The present invention provides a novel use of coccidian, specifically relates to the use of coccidian as a vaccine live vector. The present invention further provides a live vaccine with coccidian as a vector, which is transgenic coccidian capable of expressing exogenous protein or stably transfected coccidian that contain expression vector and can express exogenous coccidian. The present coccidian vector live vaccine can induce organisms to simultaneously generate protective humoral and cellular immune responses (including the mucosal immune response), as well as generate memory responses, which can be readily carried out and has stable effect and high biological safety without generating immune tolerance.

Abstract: The present invention provides an immunogenic composition comprising an antigen or antigen composition and an adjuvant composition comprising an oil in water emulsion, wherein said oil in water emulsion comprises 0.5-10 mg metabolisable oil, 0.5-11 mg tocol and 0.1-4 mg emulsifying agent, per human dose.

Abstract: The present invention relates to an isolated attenuated influenza virus strain and a live vaccine comprising the same. The isolated attenuated influenza virus strain is prepared by cold-adaptation of a mother strain which carries 6 internal genomes of A/PR/8/34(H1N1) and two surface antigens HA and NA of A/Aichi/2/68(H3N2). The attenuated influenza virus strain and the live vaccine of the present invention are useful for prevention of seasonal influenza episodes and sudden outbreak of influenza pandemics of predicted or unknown identity, since they have safety, efficacy, high production yield, immediate protection against variety of influenza subtypes and prolonged protection against specific influenza subtype.

Abstract: Disclosed is a preparation for transnasal application, which has improved fluidability. Specifically disclosed is a preparation for transnasal application, which comprises at least a complex comprising: a fluidability-improving component comprising a first crystalline cellulose (A) having specified powder properties, tricalcium phosphate (B) having specified powder properties, and a second crystalline cellulose (C) having specified powder properties or a starch (D) having specified powder properties; and a physiologically active substance.

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

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 invention provided herein relates to vaccines that can be tailored to achieve a desired immune response. Some compositions provided herein are used for preferentially eliciting a humoral immune response while other compositions are useful for preferentially eliciting a cell-mediated response. Combinations of vaccine compositions are also useful for eliciting both types of responses and/or for modulating the type of immune response elicited. The invention also provides methods for eliciting an immune response in an individual by administering the compositions disclosed herein. These immune responses are useful for protecting an individual from various types of diseases, infections, and undesirable conditions.

Abstract: The present invention covers a novel replication deficient influenza virus comprising a modified NS1 segment coding for a NS1 protein lacking a functional RNA binding domain and functional effector domain and a heterologous sequence inserted between the splice donor site and the splice acceptor site of the NS gene segment. Further the use of the virus as vector for expression of various proteins like chemokines, cytokines or antigenic structures is covered, methods for producing virus particles using said virus vector as well as its use for production of vaccines. Also a fusion peptide comprising part of the N-terminus of an NS1 protein and a signal sequence fused to the C-terminus of said NS1 peptide is covered.

Abstract: Disclosed are vaccines and vaccine adjuvants useful in the treatment and/or prevention of infection and diseases associated with infectious pathogens, such as tetanus, as well as diseases associated with biological toxins. Also provided are methods of preparing an adjuvant and the vaccine containing the adjuvant. Methods are also provided for vaccinating/immunizing an animal against infection and diseases associated with infectious pathogens, such as tetanus, and other diseases associated with biological toxins. Adjuvant materials are presented that are prepared from an extracellular matrix material. The adjuvants are demonstrated to enhance the immunogenicity of an infectious pathogen antigen or biological toxin antigen of interest, as well as to enhance the survival of an immunized animal.

Abstract: The present invention provides a linear expression construct free of any conventional amplification and/or selection sequences comprising an RNA polymerase I (polI) promoter and a polI termination signal, inserted between a RNA polymerase II (polII) promoter and a polyadenylation signal useful for the expression of segments of viral RNA, preferably influenza viruses. The inventive construct is useful for efficient and fast production of viral particles, especially for producing vaccine formulations for the treatment of epidemic and/or pandemic diseases.

Abstract: The present invention aims to provide a freeze-dried preparation in which the influenza vaccine exhibits improved stability. A freeze-dried preparation in which the influenza vaccine exhibits significantly improved stability can be obtained by freeze-drying an aqueous solution that meets the following conditions (A) to (C): (A) (i) an influenza vaccine, (ii) a hydrophobic amino acid, and (iii) arginine and an acid addition salt thereof are incorporated; (B) the proportion of the component (iii) is from 20 to 85% by weight relative to the total amount of the resulting freeze-dried preparation; and (c) the pH is adjusted to be from 8 to 10 by controlling the proportion of arginine and an acid addition salt thereof that form the component (iii).

Abstract: The invention refers to an improved vaccine against infections with pathogens, especially viral pathogens, comprising an antigen, a peptide of the formula R1—XZXZN-XZX—R2 and an immunostimulatory deoxynucleic acid containing deoxyinosine and/or deoxyuridine residues.

Abstract: The present invention relates to a live-attenuated bacterial cell comprising a heterologous nucleotide sequence encoding at least one influenza virus antigen in operative linkage to an expression system.

Abstract: The present invention relates to an isolate canine influenza virus. The present invention relates to an isolated nucleic acid molecule encoding a hemagglutinin from a canine influenza virus. The present invention also relates to the protein or polypeptide encoded by the isolated nucleic acid molecule. Vaccines and detection and treatment methods relating to canine influenza viruses are also disclosed.

Abstract: Antigens from individual influenza virus strains are not refrigerated before being combined to make multivalent influenza virus vaccines. Moreover, influenza vaccines are not refrigerated between packaging and administration. Thus the need for refrigeration is minimized, and the cold-chain does not have to be maintained between vaccine manufacture and administration.

Abstract: Disclosed herein are methods of modulation of the viability of a cell. Further disclosed herein are methods of modulating an immune response. Further disclosed herein are methods of identifying agents capable of modulation of the viability of a cell or an immune response. Further disclosed herein are agents and compositions capable of modulation of the viability of a cell or an immune response.

Abstract: Provided is a polypeptide having no more than 100 amino acids, which polypeptide comprises one or more sequences having at least 60% homology with any of SEQ ID 1-6, or comprises two or more epitopes having 7 amino acids or more, each epitope having at least 60% homology with a sub-sequence of any of SEQ ID 1-6 that has the same length as the epitope: SEQ ID 1 DLEALMEWLKTRPILSPLTKGILGFVFTLTVP SEQ ID 2 LLYCLMVMYLNPGNYSMQVKLGTLCALCEKQASHS SEQ ID 3 DLIFLARSALILRGSVAHKSC SEQ ID 4 PGIADIEDLTLLARSMVVVRP SEQ ID 5 LLIDGTASLSPGMMMGMFNMLSTVLGVSILNLGQ SEQ ID 6 IIGILHLILWILDRLFFKCIYRLF wherein, the polypeptide is immunogenic in a vertebrate expressing a major histocompatibility complex (MHC) allele, and wherein the polypeptide is not a complete influenza virus protein.

Abstract: Attenuated, neuraminidase deficient influenza virus, and compositions and methods to prepare that virus, are provided.

Abstract: Methods for making and using therapeutic formulations of Proteosome-based immunoactive compositions are provided. The immunogenic compositions, which include Proteosomes and liposaccharides, may be used to elicit or enhance a nonspecific innate immune response to, for example, treat or prevent infectious disease. In addition, after activating the innate immune system, immunogenic compositions further containing an antigen may be used to elicit a specific adaptive immune response. Furthermore, provided are compositions capable of altering hyperreactive responses or inflammatory immune responses, such as allergic reactions. Such compositions may be used as a prophylactic, or in various clinical settings to treat or prevent infectious disease (such as parasite, fungal, bacterial or viral infections), or to alter inappropriate inflammatory immune responses (such as allergic reactions or asthma).

Abstract: The invention proyides novel compositions comprising imidazoquinoxaline compounds of formula (I) and analogs thereof. 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 to vaccine products for the treatment or prevention of viral infections. Further provided are methods of reducing contaminants associated with the preparation of cell culture vaccines. Residual functional cell culture DNA is degraded by treatment with a DNA alkylating agent, such as ?-propiolactone (BPL), thereby providing a vaccine comprising immunogenic proteins derived from a virus propagated on cell culture, substantially free of residual functional cell culture DNA.

Abstract: The present invention relates to an immunogenic composition for raising an immune response to an antigen, the composition comprising the antigen and a targeting moiety specific for lymph-resident dendritic cells. Use of the immunogenic composition in a vaccine and methods of boosting an immune response using the composition are also provided. Conversely, the invention also relates to immunogenic composition for raising an immune response to an antigen, the composition comprising the antigen and a targeting moiety specific for tissue-derived dendritic cells and a vaccine comprising said composition.

Abstract: Influenza vaccines containing insoluble particulate adjuvants have been found to elicit an IgG response that is primarily a TH2 response (IgG1). This response can be shifted towards a TH1 response (IgG2a) by including immunopotentiators in the compositions. Thus the invention provides an immunogenic composition comprising: (i) an influenza virus antigen; (ii) an insoluble particulate adjuvant; and (iii) a immunopotentiator.

Abstract: The invention provides an improved Mycoplasma hyopneumoniae bacterin vaccine composition, which advantageously provides immunity from infection after a single administration. The composition comprises an inactivated Mycoplasma hyopneumoniae bacterin and an adjuvant mixture, which, in combination, provide immunity from Mycoplasma hyopneumoniae infection after a single administration, and elicit an immune response specific to Mycoplasma hyopneumoniae bacterin and including cell-mediated immunity and local (secretory IgA) immunity. In a preferred embodiment, the adjuvant mixture comprises an acrylic acid polymer, most preferably CARBOPOL®, and a mixture of a metabolizable oil such as one or more unsaturated terpene hydrocarbons, preferably squalene or squalane, and a polyoxyethylene-polypropylene block copolymer such as PLURONIC®. The vaccine composition may optionally include a preservative, preferably thimerosol and/or EDTA.

Abstract: A method of detecting osteoporosis in a mammalian is disclosed herein which includes: a) obtaining a sample of a bone related tissue or cells; and b) measuring the concentration of at least a marker which is either bacteria, bacteria produced factors, or HSPs. The method may further include comparing the concentration with concentrations from the same individual over a period of time or against a standard concentration. The marker may be a bacteria, a chaperone molecule, or a bacteria produced. Also provided herein is a method of treating or preventing osteoporosis caused by a bone disease which includes administering to a mammalian subject a therapeutically effective amount of a formulation which is either an HSP antigenic formulation or a bacterial antigenic formulation. The osteoporosis can be caused by a bone disease induced by bone infectious agents such as viruses, bacteria, fungi, protozoa and parasites.

Abstract: The invention concerns the use of Lactobacillus casei in a composition for oral administration to enhance immunity specific to pathogenic micro-organisms. Said composition can in particular be a food or a food supplement.

Abstract: An adjuvant complex composed of bacterial outer membrane protein proteosomes complexed to bacterial liposaccharide is prepared to contain the component parts under a variety of conditions. The complex can be formulated with antigenic material to form immunogenic compositions, vaccines and immunotherapeutics. An induced immune response includes protective antibodies and/or type 1 cytokines is shown for a variety of protocols.

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

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 split influenza virus vaccine is adjuvanted with an oil-in-water emulsion that contains free surfactant in its aqueous phase. The free surfactant can continue to exert a “splitting effect” on the antigen, thereby disrupting any unsplit virions and/or virion aggregates that might be present.

Abstract: The invention provides adjuvants, immunogenic compositions, and methods useful for polynucleotide-based vaccination and immune response. In particular, the invention provides an adjuvant of cytofectin:co-lipid mixture wherein cytofectin is GAP-DMORIE.

Abstract: A newly identified serum resistance factor of gram positive bacteria can be used to treat or prevent bacterial infection.

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

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

Abstract: Vectors and methods for the production of influenza viruses suitable as recombinant influenza vaccines in cell culture are provided. Bi-directional expression vectors for use in a multi-plasmid influenza virus expression system are provided. Additionally, the invention provides methods of producing influenza viruses with enhanced ability to replicate in embryonated chicken eggs and/or cells (e.g., Vero and/or MDCK) and further provides influenza viruses with enhanced replication characteristics. A method of producing a cold adapted (ca) influenza virus that replicates efficiently at, e.g., 25° C. (and immunogenic compositions comprising the same) is also provided.

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

Abstract: Immunogenic compositions are described herein which comprise microparticles that further comprise a biodegradable polymer. The microparticle compositions also comprise a cationic polysaccharide and an immunological species selected from an antigen, an immunological adjuvant and a combination thereof. Also described are methods of making such compositions and methods of administering such compositions. Methods of modulating the release rate of immunological species from microparticles are also described. These methods comprise varying the ratio of the cationic polysaccharide relative to the biodegradable polymer within the microparticles.

Abstract: The present invention relates to the isolation and identification of two new strains of type 2B porcine circovirus. These two new strains of porcine circovirus may be used for the preparation of vaccine or immunogenic compositions for immunizing pigs against postweaning multisystemic wasting syndrome (PMWS). Accordingly, the invention provides methods for eliciting a protective immune response against a pathogenic porcine circovirus by administering to a pig an immunogenically effective amount of a type 2B porcine circovirus vaccine or immunogenic composition comprising at least one of the porcine circoviruses having a nucleic acid sequence as set forth in SEQ ID NOs: 1 or 2, or at least one protein from at least one of the two new type 2B strains of porcine circovirus as described herein. The invention further relates to protection of a pig from any one or more of the symptoms or sequelae associated with PMWS.

Abstract: The invention relates to the use of a non-live influenza virus antigen preparation, particularly a split influenza virus preparation, in the manufacture of a vaccine formulation for a one-dose intranasal vaccination against influenza, wherein the one-dose vaccination meets international regulatory requirements for influenza vaccines. Further provided are methods for the production of the vaccine, and a pharmaceutical kit comprising an intranasal administration device and the one-dose vaccine.

Abstract: The present invention relates to an adjuvant comprising a lipopeptide and poly I:C. When the adjuvant of the present invention is used, the level of antigen specific antibody induction is synergistically increased and Th1 type immune response is also induced. Therefore, the adjuvant of the present invention can be very effectively used as an adjuvant in the formulation of preventive and therapeutic vaccines for viral or parasitic infection and cancer.

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

Abstract: The present invention provides an immunogenic influenza composition in a dose volume suitable for human use, comprising an influenza virus antigen or antigenic preparation thereof and an adjuvant composition comprising an oil-in-water emulsion, wherein said oil-in-water emulsion comprises a metabolisable oil at a level of below 11 mg and an emulsifying agent at a level of below 5 mg and optionally a tocol or a sterol at a level of below 12 mg. Suitably the amount of influenza antigen per strain per dose is 15 ?g HA or a low amount such as less than 15 ?g HA.

Abstract: The present invention provides methods for eliciting an effective immune response against a weakly immunogenic disease or for priming T cells to become memory T cells against a weakly immunogenic disease by directly vaccinating into the bone marrow of the patient an antigen associated with the weakly immunogenic disease. Also included in the present invention is an isolated population of human memory CD8+ T cells from the bone marrow which is in a heightened activation state with a unique effector phenotype.

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 invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated forms of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.