Abstract: Novel influenza viruses A/Canine/Korea/01/07 (H3N2), A/Canine/Korea/02/07 (H3N2) and A/Canine/Korea/03/07 (H3N2) are disclosed. A vaccine composition comprising at least one of the viruses, a method for preventing or treating diseases resulting from influenza virus infection by administering the vaccine composition, and an assay kit for detecting the viruses are also disclosed.

Abstract: Methods and compositions for the optimization and production of refrigerator-temperature stable virus, e.g., influenza, compositions are provided. Formulations and immunogenic compositions comprising refrigerator-temperature stable virus compositions are provided.

Abstract: The present invention relates to the use of avian cell lines for the preparation of seed influenza vaccines, and to vaccines made therefrom.

Abstract: The invention relates to generic methods for the detection and quantification of influenza viruses. These may uses a reverse transcription (RT-PCR) real time (q-PCR) assay which amplifies a conserved region within influenza A or B strains. The assays allow the quantification of influenza virus RNA molecules or whole virus particles, irrespective of the particular virus strain (e.g. human, avian, swine flu). The methods are particularly applicable as diagnostic assays or in the monitoring of vaccine production processes.

Abstract: Transcutaneous immunization can deliver antigen to the immune system through the stratum corneum without physical or chemical penetration to the dermis layer of the skin. This delivery system induces an antigen-specific immune response without the use of a heterologous adjuvant. This system can induce antigen-specific immune effectors after epicutaneous application of a formulation containing one or more antigens Immune responses that provide prophylactic and/or therapeutic treatments are preferred. Antigenic activities in the formulation may be found in the same molecule, two or more different molecules dissociated from each other, or multiple molecules in a complex formed by covalent or non-covalent bonds. For antigens which are proteinaceous, they may be provided in the formulation as a polynucleotide for transcutaneous genetic immunization. Besides simple application of a dry or liquid formulation to the skin, patches and other medical devices may be used to deliver antigen for immunization.

Abstract: The present invention includes cold-adapted, acid-fast bacterium for use as a vaccine and a vaccine vector. In preferred embodiments, the cold-adapted, acid-fast bacterium is a Mycobacteria, for example, Mycobacteria shottsii.

Abstract: This invention, in one aspect, relates to synthetic immunoreactive peptides. These peptides are approximately 20-25 amino acids in length which are portions of the N termini of the M proteins of the most prevalent United States (U.S.) Group A Streptococcus (GAS) serotypes. At least some of the synthetic peptides can be recognized by M type-specific antibodies and are capable of eliciting functional opsonic antibodies and/or anti-attachment antibodies without eliciting tissue cross-reactive antibodies. In another aspect, it relates to compositions or vaccines comprising these synthetic serotype-specific peptides, including polypeptides and proteins. The invention may also be isolated antibodies which are raised in response to the peptides, compositions or vaccines. The invention further relates to kits for using the peptides, compositions, or antibodies.

Abstract: Provided are peptide vaccines including the signal peptide domain of selected target antigens of intracellular pathogens. The peptide vaccines of the invention contain multiple class II and class I-restricted epitopes and are recognized and presented by the majority of the vaccinated human population. Further provided, in particular, are anti tuberculosis vaccines. Also further provided are compositions including the vaccines as well as their use to treat or prevent infection.

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: Mucosal immunization using one or more antigens following parenteral administration of the same or different antigens is described.

Abstract: Methods of inhibiting the replication of influenza viruses in a biological sample or patient, of reducing the amount of influenza viruses in a biological sample or patient, and of treating influenza in a patient, comprises administering to said biological sample or patient an effective amount of a compound represented by Structural Formula (I): or a pharmaceutically acceptable salt thereof, wherein the values of Structural Formula (IA) are as described herein. A compound is represented by Structural Formula (IA) or a pharmaceutically acceptable salt thereof, wherein the values of Structural Formula (IA) are as described herein. A pharmaceutical composition comprises an effective amount of such a compound or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, adjuvant or vehicle.

Abstract: The disclosure relates to immunizing agents and devices.

Abstract: The present invention relates to an adjuvant composition containing poly-gamma-glutamic acid-chitosan nanoparticles and a vaccine composition containing the adjuvant composition, and more particularly to an adjuvant composition containing nanoparticles prepared by ionic bonding between poly-gamma-glutamic acid having ensured safety and chitosan, and a vaccine composition containing the poly-gamma-glutamic acid-chitosan nanoparticles and an antigen. The adjuvant containing the poly-gamma-glutamic acid-chitosan nanoparticles has little or no toxicity and side effects and is added to human or animal vaccines for the prevention and treatment of viral and bacterial infections and cancers to increase the production of antibodies.

Abstract: The present invention provides a novel influenza virus wherein both the NS and the PB1 gene segments are modified and wherein the PB1-F2 open reading frame is modified by introduction of at least one stop codon. Specifically, the influenza virus is lacking functional NS1 and PB1-F2 proteins. Additionally, a vaccine formulation comprising said modified influenza virus is provided and its use for prevention of influenza infection.

Abstract: Antigenic peptides are provided that can be used to induce global neutralizing antibodies, or antibodies reactive against a wide range of influenza A virus strains. The antigenic peptide can correspond to SEQ ID NO: 34 (EKEVLVLWG), SEQ ID NO: 2 (KFDKLYIWG), SEQ ID NO: 71(QEDLLVLWG), SEQ ID NO: 51 (EGRINYYWTLLEP), SEQ ID NO: 3 (PSRISIYWTIVKP), and/or SEQ ID NO: 82 (SGRMEFFWTILKP).

Abstract: The invention relates to the field of influenza vaccine production. Influenza vaccines have been produced in embryonated hens' eggs for over 50 years, but recently there have been considerable efforts to develop cell culture systems for vaccine production. In one embodiment, the invention provides a nucleic acid comprising an influenza gene segment and a bacteriophage polymerase promoter or a complementary strand of said nucleic acid, and a cell comprising such a nucleic acid capable of producing desired influenza virus. In another embodiment, the invention provides a composition comprising a cell or material derived from a cell according to the invention and a virus or material derived from a viral particle according to the invention.

Abstract: The present invention provides novel serum-free cell culture medium and methods for cultivating MDCK cells. In particular, non-tumorigenic MDCK cells. The present invention also provides methods for producing influenza viruses (e.g., particularly cold-adapted, and/or temperature sensitive, and/or attenuated influenza viruses) that eliminate the need for a cell culture medium exchange step. The novel medium and methods are useful to grow influenza viruses, in cell culture to high titer. The present invention further provides purification methods for purifying influenza viruses with high overall recovery of live virus and result in levels of host cell DNA (HCD), host cell protein (HCP) and non-specific endonuclease (e.g., Benzonase), which are below the specifications required by regulatory agencies. The immunogenic compositions can be used to actively immunize subjects or to generate antibodies for a variety of uses, including passive immunization and diagnostic immunoassays.

Abstract: The present invention relates to novel hemagglutinin H5 proteins, nucleic acids and vectors encoding for those as well as vaccines comprising any of such H5 proteins, nucleic acids or vectors encoding for those H5 proteins. Moreover, the present invention also relates to the medicinal use of any of such compositions in humans and animals.

Abstract: The invention is directed to novel live attenuated influenza virus (LAIV) vaccines comprising one or more microRNA (miRNA) Response Element(s) (MRE) within an influenza virus genome. The MREs useful for the present invention can be derived from any miRNA which is highly expressed in influenza-targeted cells of an animal in need of vaccination but are not expressed or are expressed at very low levels in species (e.g., embryonated chicken eggs) or cell lines used for a large-scale vaccine production. This allows efficient vaccine production but renders the vaccine virus susceptible to attenuation in the influenza-targeted cells of vaccinated animals expressing a cognate miRNA.

Abstract: The present invention is directed to a method for promoting or stimulating a cell-mediated immune response to an antigen, by administering a target antigen (such as a protein) with a transport factor that contains a fragment of a bipartite protein exotoxin, but not the corresponding protective antigen. Preferred transport factors include the protective antigen binding domain of lethal factor (LFn) from B. anthracis, consisting of amino acids 1-255, preferably a fragment of at least 80 amino acids that shows at least 80% homology to LFn, and a fragment of about 105 amino acids from the carboxy portion that does not bind PA. The target antigen can include any molecule for which it would be desirable to elicit a CMI response, including viral antigens and tumor antigens.

Abstract: The present invention provides methods and compositions for the stimulation of immune responses. Specifically, the present invention provides methods and compositions for the use of nanoemulsion compounds as mucosal adjuvants to induce immunity against environmental pathogens. Accordingly, in some embodiments, the present invention provides nanoemulsion vaccines comprising a nanoemulsion and an inactivated pathogen or protein derived from the pathogen. The present invention thus provides improved vaccines against a variety of environmental and human-released pathogens.

Abstract: An inhaler includes a first body member and a second body member fit closely together to form an inhaler body, and an outlet. The first body member has a medicament chamber containing a unit dose of powdered medicament. A seal such as a foil strip seals the medicament chamber and extends outwardly of the inhaler body. In use, one end of the seal can be grasped by a user and withdrawn, fully or partially, from the inhaler body, to release the powdered medicament from the medicament chamber. The second body member includes a medicament collection well in which the medicament is collected upon its release from the medicament chamber. The medicament collection well forms part of an airway connecting into the outlet. In use, air can be drawn by inhalation at the outlet to entrain the powder medicament in the collection well for inhalation by a user.

Abstract: Disclosed is a vaccine which has a high therapeutic effect on mycoplasma infection and is highly safe. For the purpose of developing effective therapeutic methods for mycoplasma infection, mycoplasma-mimic particles which are effective as a vaccine for mycoplasma infection are provided, and also provided are bacterium-mimic particles including common bacteria. Bacterium-mimic particles such as mycoplasma-mimic particles can be provided by producing liposome particles in which a lipid antigen specific to a pathogenic bacterium such as mycoplasma is contained as a liposome-constituting lipid component. The administration of the mycoplasma-mimic particles enables the induction of a potent immunological activity in living bodies. The mycoplasma-mimic particles can be used as an excellent vaccine for the prevention or treatment of mycoplasma infection.

Abstract: The invention provides a block copolypeptide comprising a hydrophilic heteropolypeptide block (A) and a hydrophobic homopolypeptide block (B). There is also provided a polymersome comprising a block copolypeptide of the invention. The invention further provides a method for preparing a copolymer comprising ring-opening polymerisation (ROP) of an amino acid N-carboxyanhydride (NCA) initiated from a peptide.

Abstract: Vaccine compositions, useful for eliciting an immune response in subjects which is protective against influenza type A virus, comprise influenza type A virus antigen and a bacterial sialidase. An intranasal vaccine against highly pathogenic subtype H5N1 virus, for use in the treatment of poultry, preferably comprises inactivated H5N1 antigen, sialidase from Clostridium perfringens A strain 107 and chitosan. The use of bacterial sialidase to potentiate influenza virus antigen vaccine is also disclosed.

Abstract: The present invention concerns methods and means for identifying, producing, and engineering neutralizing antibodies against influenza A viruses, and to the neutralizing antibodies produced. In particular, the invention concerns neutralizing antibodies against various influenza A virus subtypes, and methods and means for making such antibodies.

Abstract: The present invention is directed to compositions and methods for enhancing the immune response of a human in need of protection against influenza virus (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, or a protein encoded thereby. 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. The IV protein (in purified form or in the form of an inactivated IV vaccine) is also administered in an immunologically effective amount.

Abstract: The present invention relates to a vaccine composition comprising a carbohydrate polymer comprising mannose and flu antigen(s) (e.g. whole inactivated influenza virus) in admixture, and a method of immunising a subject comprising the step of administering the vaccine composition to a subject.

Abstract: Methods and compositions for eliciting an immune response to an antigen are disclosed. In certain aspects, these methods concern eliciting an immune response in a subject by administering to the mucosa of the subject a composition comprising a virus-like particle (“VLP”) and Murabutide.

Abstract: Calcium phosphate is used as an adjuvant, with a high degree of antigen adsorption to the adjuvant. The invention is particularly useful for adjuvanting conjugated capsular saccharide antigens. Buffers, such as phosphate or histidine buffers, can advantageously be used in combination with the calcium phosphate, and compositions may have a pH in the range of 5.5 to 7.5.

Abstract: Immunogenic compositions containing phospholipid adjuvants, including microparticle and emulsion compositions. According to one aspect of the invention, an immunogenic microparticle composition is provided comprising: water; a polymer microparticle; an antigen adsorbed to the microparticle; and a phospholipid compound, e.g., a synthetic phospholipid compound comprising: (i) one or more phosphoryl groups independently selected from a phosphato group and a phosphodiester group; (ii) a plurality of linear alkane groups. According to another aspect of the invention an immunogenic emulsion composition is provided that comprises: water; a metabolizable oil; an emulsifying agent; an antigen; and a phospholipid compound, e.g., a synthetic phospholipid compound like that above. The emulsion composition is an oil-in-water emulsion having oil and aqueous phases, in which the oil phase is in the form of oil droplets, substantially all of which are less than 1 micron in diameter.

Abstract: The present invention provides a vaccine against a viral infection. The exemplary vaccine comprises a viral antigen of a vaccine strain of a virus; wherein the viral antigen is derived from a virus preparation of the vaccine strain of the virus; wherein the virus preparation of the vaccine strain of the virus contains a subpopulation of infectious viral particles, and the subpopulation of infectious viral particles is represented as a proportion over the total viral particles or total viral antigens of the virus preparation; and wherein the proportion of the subpopulation of infectious viral particles over the total viral particles or total viral antigens of the virus preparation is over a predefined threshold; so that the vaccine provides at least partial inter-subtypic or intra-subtypic cross immune response against different strains of the virus than the vaccine strain.

Abstract: The present invention relates to a cell-based method for producing influenza virus vaccines by enriching the population of surface-bound ?2,6-sialic acid receptors on a cell surface, such as on a Chinese Hamster Ovary (CHO) cell surface. The host cell therefore presents numerous binding sites to which an influenza virus can bind via its hemagglutinin spike protein and infect the host cell. In contrast to wild-type CHO cells, the surface of the mutated CHO cells of the present invention contains an enriched population of ?2,6-sialic acid receptors which makes the inventive CHO cells highly susceptible to viral infection, and therefore safe, effective, and highly efficient cells for rapidly producing influenza vaccines.

Abstract: The present disclosure provides compositions and methods for eliciting an immune response against avian or pandemic influenza. The compositions include adenovirus vectors comprising avian influenza antigens, recombinant adenovirus and immunogenic compositions comprising such recombinant vectors and adenovirus. Methods for eliciting an immune response against avian or pandemic influenza involving administering such adenovirus vectors or recombinant adenovirus are also provided.

Abstract: The present application describes methods for assessing influenza infection, including prognosis. An assay that determines the amount of the NS1 and NP proteins of influenza virus shows enhanced sensitivity and reliability compared to either antigen alone. Many formats employ pan-specific antibodies (i.e., that react with all or at least with multiple strains within an influenza type).

Abstract: The present invention provides methods and compositions for rapidly producing multivalent recombinant vaccines using filamentous fungal heterokaryons. The present invention relies on the use of filamentous fungal heterokaryons that are generated from combinations of two or more parent strains into which recombinant DNA molecules encoding variants of antigens derived from pathogenic organisms have been introduced. The resulting vaccines are multivalent.

Abstract: In contrast to known regimens where pandemic-associated antigens are given 3-4 weeks apart for immunisation, according to the invention two doses of a pandemic-associated antigen are administered to a human 1 week apart, 2 weeks apart or 6 weeks apart. Thus the invention provides a method for immunizing a human, comprising steps of: (a) administering to the human a first vaccine comprising antigen from a pandemic-associated influenza virus strain; and then 1/2/6 week(s) later, (b) administering to the same human a second influenza vaccine comprising antigen from the pandemic-associated influenza virus strain.

Abstract: A fast-dissolving dosage form (FDDF) for the delivery of a vaccine is prepared using a formulation containing a starch, optionally, along with at least one additional matrix forming agent, preferably, a combination of gelatin and mannitol, wherein an immune response is induced in a patient in need thereof.

Abstract: The present invention provides a vaccine composition for transnasal mucous membrane administration, which contains an influenza virus antigen, polyriboinosinic polyribocytidylic acid (poly (I:C)) or a derivative thereof and a carboxyvinyl polymer. The present invention also provides a prophylactic method of influenza, including a step of administering the vaccine composition at least once to the nasal mucosa of a subject in need thereof.

Abstract: Influenza vaccines include hemagglutinin from at least one influenza A virus strain and at least one influenza B virus strain. They also include an oil-in-water emulsion adjuvant with submicron oil droplets, comprising squalene. In some embodiments the hemagglutinin concentration is >12 ?g/ml per strain. In some embodiments the squalene concentration is <19 mg/ml. In some embodiments the vaccine is mercury-free. In some embodiments the vaccine has a unit dose volume between 0.2-0.3 mL. In some embodiments the squalene concentration is 9.75 mg/mL or 4.88 mg/mL. In some embodiments the vaccine includes antigens from two influenza A virus strains and two influenza B virus strains.

Abstract: The present invention relates to immunodominant compositions, including immunodominant peptides of HA1 of influenza H5 hemagglutinin, polynucleotides encoding such peptides, and their methods of use. Such peptides are useful, for example, for the prevention, treatment and diagnosis of influenza.

Abstract: The present invention relates, in general, to attenuated equine influenza viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. In particular, the invention relates to attenuated equine influenza viruses having modifications to an equine NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. These viruses replicate in vivo, but demonstrate decreased replication, virulence and increased attenuation, and therefore are well suited for use in live virus vaccines, and pharmaceutical formulations.

Abstract: The present invention relates to a method of immune activation which is effective for eliciting a non-antigen-specific immune response in a member of the avian species. The method is particularly effective for protecting a member of the avian species from infectious disease and treating animals inflicted with infectious disease.

Abstract: Provided herein are nucleic acid sequences that encode novel consensus amino acid sequences of HA hemagglutinin, as well as genetic constructs/vectors and vaccines expressing the sequences. Also provided herein are methods for generating an immune response against one or more Influenza A serotypes using the vaccines that are provided.

Abstract: This invention relates to compositions and methods that can be used immunize a subject against influenza. Generally, the compositions and methods include peptides obtained or derived from human influenza A virus M2 protein.

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: The present invention relates, in general, to attenuated swine influenza viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. In particular, the invention relates to attenuated swine influenza viruses having modifications to a swine NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. These viruses replicate in vivo, but demonstrate decreased replication, virulence and increased attenuation, and therefore are well suited for use in live virus vaccines, and pharmaceutical formulations.

Abstract: Various nucleic acid-based matrixes are provided, comprising nucleic acid monomers as building blocks, as well as nucleic acids encoding proteins, so as to produce novel biomaterials. The nucleic acids are used to form dendrimers that are useful as supports, vectors, carriers or delivery vehicles for a variety of compounds in biomedical and biotechnological applications. In particular, the macromolecules may be used for the delivery of drugs, genetic material, imaging components or other functional molecule to which they can be conjugated. An additional feature of the macromolecules is their ability to be targeted for certain organs, tumors, or types of tissues. Methods of utilizing such biomaterials include delivery of functional molecules to cells.

Abstract: The invention relates to methods for one-dose influenza vaccine for intradermal delivery of a trivalent, non-live influenza antigen preparation, particularly a split influenza preparation.

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.