Abstract: The invention relates to a method for preventing or treating an influenza virus infection in a subject, the method comprising administering to the subject a therapeutically effective amount of a gamma-irradiated influenza virus, wherein the virus comprises an A/Port Chalmers/1/73 (A/PC) strain backbone of PB2, PB1, PA, NP, M1, M2 and NEP proteins.

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: The present disclosure provides compositions and methods useful for treating influenza. As described herein, provided compositions and methods are based on the development of certain compositions that include an influenza virus hemagglutinin antigen in combination with lipid vesicles that include a non-ionic surfactant (NISVs) and optionally an adjuvant. In certain embodiments, provided compositions remain potent even when they are not stored in a standard cold-chain system (i.e., they are thermostable).

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

Abstract: The invention provides 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: This disclosure relates to compositions and methods for inducing immune response. Specifically, the disclosure relates to a composition comprising a subunit antigen stabilized by a polysaccharide-containing plant extract, in which the antigen consists of virus-like particles that have enhanced mucosal immuno-genicity as a result of the stabilization.

Abstract: The present invention provides an immunogenic composition comprising one or more antigens and a Toll-like receptor (TLR) agonist in an orally (e.g. sublingually) administered composition.

Abstract: Compositions and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response are disclosed based on the discovery of useful immunological adjuvant properties in a synthetic, glucopyranosyl lipid adjuvant (GLA) that is provided in substantially homogeneous form. Chemically defined, synthetic GLA offers a consistent vaccine component from lot to lot without the fluctuations in contaminants or activity that compromise natural-product adjuvants. Also provided are vaccines and pharmaceutical compositions that include GLA and one or more of an antigen, a Toll-like receptor (TLR) agonist, a co-adjuvant and a carrier such as a pharmaceutical carrier.

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

Abstract: The present invention encompasses influenza vaccines, in particular avian influenza vaccines. The vaccine may be a subunit vaccine based on the hemagglutinin of influenza. The hemagglutinin may be expressed in plants including duckweed. The invention also encompasses recombinant vectors encoding and expressing influenza antigens, epitopes or immunogens which can be used to protect animals against influenza. It encompasses also a vaccination regimen compatible with the DIVA strategy, including a prime-boost scheme using vector and subunit vaccines.

Abstract: Compositions and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response are disclosed based on the discovery of useful immunological adjuvant properties in a synthetic, glucopyranosyl lipid adjuvant (GLA) that is provided in substantially homogeneous form. Chemically defined, synthetic GLA offers a consistent vaccine component from lot to lot without the fluctuations in contaminants or activity that compromise natural-product adjuvants. Also provided are vaccines and pharmaceutical compositions that include GLA and one or more of an antigen, a Toll-like receptor (TLR) agonist, a co-adjuvant and a carrier such as a pharmaceutical carrier.

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 serotpyes using the vaccines that are provided.

Abstract: The present invention relates to a universal H5N1 vaccine. More specifically, the present invention relates to the identification of three H5N1 strains which cover the entire variants in the neutralizing epitopes of hemagglutinin among most H5N1 lineages. The present invention further relates a universal H5N1 vaccine that comprises the three H5N1 strains or that comprises hemagglutinin peptides of each of these three strains.

Abstract: Disclosed herein are compounds and related compositions for the treatment of viral infection, including RNA viral infection, and compounds that can modulate the RIG-I pathway in vertebrate cells, including compounds that can activate the RIG-I pathway.

Abstract: Disclosed herein are immunogenic compositions for producing immediate and sustained immunity to infectious viral and bacteriological pathogens. A univalent immunogenic composition is disclosed comprising an isolated antigen and a polynucleotide formulated into a nanoparticle or liposome. Furthermore, multivalent immunogenic compositions are disclosed comprising multiple univalent immunogenic compositions. Also disclosed, are methods of inducing protective or therapeutic immune responses in individuals comprising administering one or more univalent immunogenic compositions.

Abstract: This invention discloses a method of increasing production of virus-like particles comprising expressing an avian influenza matrix protein. The invention also comprises methods of making and using said VLPs.

Abstract: Methods of stabilizing solutions with enveloped vims-based virus-like particles containing an influenza antigen and such stabilized solutions are described.

Abstract: The present invention relates to novel MDCK cells which can be to grow viruses, e.g., influenza viruses, in cell culture to higher titer than previously possible. The MDCK cells can be adapted to serum-free culture medium. The present invention further relates to cell culture compositions comprising the MDCK cells and cultivation methods for growing the MDCK cells. The present invention further relates to methods for producing influenza viruses in cell culture using the MDCK cells of the invention.

Abstract: According to the present invention, there is provided a means of expressing and displaying a protein on the cell surface of a bifidobacterium. In the gene for expressing a protein on the surface of a bifidobacterium of the present invention, a gene coding for a bifidobacterium-derived GNB/LNB substrate-binding membrane protein and a gene coding for the target protein or peptide are linked in this order from the 5? end side. Thus, a bifidobacterium transformed by introducing the gene for expressing a protein on the surface of a bifidobacterium of the present invention expresses the target protein or peptide on the surface thereof. When the target protein or peptide is an antigen protein or an antigen peptide, the transformed bifidobacterium of the present invention is useful as an oral vaccine.

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.

Abstract: Improved anti-HIV immunogens and nucleic acid molecules that encode them are disclosed. Immunogens disclosed include those having consensus sequences for HIV Subtype A Envelope protein, those having consensus sequences for HIV Subtype B Envelope protein, those having consensus sequences for HIV Subtype C Envelope protein, those having consensus sequences for HIV Subtype D Envelope protein, those having consensus sequences for HIV Subtype B consensus Nef-Rev protein, and those having consensus sequences form HIV Gag protein subtypes A, B, C and D. Improved anti-HPV immunogens and nucleic acid molecules that encode them; improved anti-HCV immunogens and nucleic acid molecules that encode them; improved hTERT immunogens and nucleic acid molecules that encode them; and improved anti-Influenza immunogens and nucleic acid molecules that encode them are disclosed as well methods of inducing an immune response in an individual against HIV, HPV, HCV, hTERT and Influenza are disclosed.

Abstract: A method for enhancing a body's response to an immunogen is disclosed. The method comprises immunizing a subject in need thereof a vaccine composition in a water-in-oil (W/O/W) emulsion that comprises (a) an antigen; and (b) an adjuvant composition in a W/O/W emulsion. The adjuvant composition comprises: (i) a continuous aqueous phase comprising H2O; (ii) an oil phase comprising oil dispersed in the continuous aqueous phase, comprising an internal aqueous phase comprising H2O, being dispersed in the oil phase; and a physiologically acceptable lipophilic emulsifier selected from the group consisting of mannide monooleate and sorbitan esters, stabilizing the interface between the inner aqueous phase and the oil phase to form a water-in-oil (W/O) emulsion; and (iii) poly(ethylene glycol)-block-poly(lactide-co-?-caprolactone), stabilizing the interface between the oil phase and the continuous aqueous phase.

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

Abstract: The present invention provides novel peptide immunogens comprising influenza virus matrix 2 protein epitopes and related compositions and methods. The present invention relates to a composition comprising a peptide immunogen useful for the prevention and treatment of an influenza virus-mediated disease. The invention also relates to vaccines, immunogenic products and immunogenic compositions containing the peptide immunogens.

Abstract: The invention relates to the use preferably of at least one active ingredient for the prophylaxis or therapy of a viral disease, wherein this active ingredient inhibits at least one component of the cellular signal transduction pathway for the activation of the transcription factor NF-kB such that virus multiplication is inhibited. The present invention relates furthermore to the local, preferably aerogenic, administration of the active ingredient according to the invention for inhibiting virus multiplication. The active ingredient according to the invention may be combined with at least one further antivirally effective substance for the prophylaxis or therapy of a viral disease.

Abstract: The present invention is based on the development of a dual promoter system (preferably a RNA pol I-pol II system) for the efficient intracellular synthesis of viral RNA. The resultant minimal plasmid-based system may be used to synthesize any RNA virus, preferably viruses with a negative single stranded RNA genome. The viral product of the system is produced when the plasmids of the system are introduced into a suitable host cell. One application of the system is production of attenuated, reassortant influenza viruses for use as antigens in vaccines. The reassortant viruses generated by cotransfection of plasmids may comprise genes encoding the surface glycoproteins hemagglutinin and neuraminidase from an influenza virus currently infecting the population and the internal genes from an attenuated influenza virus. An advantageous property of the present invention is its versatility; the system may be quickly and easily adapted to synthesize an attenuated version of any RNA virus.

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 invention provides a packaging (incorporation) signal for influenza virus vectors, and methods of using the signal to transmit and maintain influenza viral and foreign nucleic acid in virus and cells.

Abstract: A viral vaccine, specifically an influenza vaccine, comprises a combination of a component (a1) represented by a detoxified or non-toxic mutant of subunit A of an AB type exotoxin, and a component (a2) represented by at least one substance selected from the group consisting of metal salts and mineral salts, in association with a viral immunogen.

Abstract: This invention relates to cholesterol-sequestering agents and methods of using cholesterol-sequestering agents to treat or prevent infection. The compositions of the invention can be used in vitro or in vivo to decrease the load of a microorganism in a biological sample. Methods of generating an immune response against a microorganism are also included.

Abstract: The immunogenicity of the influenza virus hemagglutinin (HA) molecule may be increased by substitutions of amino acids in the HA sequence. The substitution of specific HA residues, such as asparagine at position 223 of H5 HA, increase the sensitivity of the hemagglutinin inhibition (HI) assay by altering receptor specificity and/or antibody-antigen binding. HA molecules containing such substitutions will be useful in the development of diagnostic reference viruses and improved influenza vaccines.

Abstract: Described herein are vaccines and the use of naked DNA and/or RNA encoding hemagglutinin (HA) from pandemic influenza, e.g., the 1918 H1N1 and/or the 1957 H2N2 and/or the 1968 H3N2 influenza A virus, as a vaccine component against present day and coming H1, H2, H3, H5, N1, N2 containing influenza A infections in humans and swine optionally with the naked DNA and/or RNA encoding Neuraminidase (NA) and/or matrix protein (M) and/or the nucleoprotein (NP) from pandemic influenza virus included. If the vaccine components are used as DNA or RNA vaccines with or without the corresponding protein, the codons can optionally be “humanized” using preferred codons from highly expressed mammalian genes and the administration of this DNA vaccine can be by saline or buffered saline injection of naked DNA or RNA, or injection of DNA plasmid or linear gene expressing DNA fragments coupled to particles. Addition of the matrix protein (M) and/or the nucleoprotein (NP) from the 1918 influenza strain is also disclosed.

Abstract: This disclosure relates to the prevention and treatment of Influenza, and more particularly Influenza A Virus Subtype H1N1, with the use of a pharmaceutical composition comprising one or more digestive enzymes, such as pancreatic enzymes and porcine pancreatic enzymes. The disclosure further relates to the use of an individual's fecal chymotrypsin level as an indicator e.g., biomarker of whether an individual may be more susceptible to Influenza, e.g., Influenza A Subtype H1N1, and/or whether an individual will benefit from administration of the described pharmaceutical compositions. Use of the compositions as sanitizers, antiseptics, disinfectants, and detergents, e.g., to reduce or eradicate influenza virus present on living or inanimate surfaces is also contemplated.

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: Described herein are modified influenza virus NS gene segments and nucleic acid sequences encoding such modified influenza virus NS gene segments. In certain embodiments, a modified influenza virus NS gene segment described herein comprises an influenza virus NS 1 open reading frame (ORF) lacking a stop codon, a heterologous nucleotide sequence, a 2A autoproteolytic cleavage site or another cleavage site, an NEP ORF, wherein the gene segment has one or more mutations in either the splice acceptor site, splice donor site, or both the splice acceptor and splice donor sites that prevents splicing of mRNA. Also described herein are recombinant influenza viruses comprising a modified influenza virus NS gene segment and the use of such viruses. The recombinant influenza viruses may be use in the prevention and/or treatment of influenza virus disease or as a delivery vector.

Abstract: The invention provides compositions of inactivated influenza virus that can be used as vaccines and immunological compositions useful for inhibiting, preventing and treating influenza.

Abstract: A modified peptide derived from matrix protein 2 (hereinafter also referred to as “M2”), one of surface layer proteins of influenza virus, and a method for utilization of the modified peptide are provided. A peptide (hereinafter also referred to as “M2eC peptide”) that is made up by inserting cysteine residue(s) into a peptide (hereinafter also referred to as “M2e”) consisting of 23 amino acid residues of from positions No. 2 to No.

Abstract: The invention provides chimeric viral expression vectors and method of use for providing an immune response against H1N1 influenza. The compositions of the invention can be used as vaccines for H1N1 strains. Advantages include rapid development and availability once a strain is isolated, and effective oral or mucosal administration.

Abstract: The invention provides immunostimulatory compositions and methods of administration thereof. Also provided are methods of administering a tryptanthrin compound in an effective amount to enhance the immune response of a subject to an antigen. Also provided are methods of administering an effective amount of a tryptanthrin to stimulate the immune response in a subject for the treatment of cancer. Further provided are methods of administering a tryptanthrin compounds as an immunotherapeutic in the treatment of infectious diseases.

Abstract: Described herein are chimeric influenza virus gene segments and nucleic acid sequences encoding such chimeric influenza virus gene segments. A chimeric influenza virus gene segment described herein comprises packaging signals found in the non-coding and coding regions of one type of influenza virus gene segment and an open reading frame of a different type of influenza virus gene segment or fragment thereof. Also described herein are recombinant influenza viruses comprising two or more chimeric influenza virus gene segments and the use of such viruses in the prevention and/or treatment of influenza virus disease.

Abstract: The present invention relates to a method of coating a spore with one or more therapeutic agents. The present invention also relates to a coated spore obtained by the method of the present invention and the use of the coated spore as a vaccine.

Abstract: Disclosed herein are vaccine compositions comprising live attenuated virus with anti-antibody to improve efficacy. Specifically exemplified herein is a composition comprising live attenuated cold adapted influenza virus and an enhancing amount of IgG anti-IgA antibody to temporarily inactivate IgA defenses. Also disclosed herein are methods of immunizing a subject to protect against influenza comprising administering compositions taught herein.

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: Provided are methods of modulating cytokine activity, e.g., for the purpose of treating viral infections. Also provided are reagents for use in screening for agonists or antagonists of IL-23.

Abstract: The invention relates to adjuvanted vaccine formulations, in particular influenza vaccines for intranasal delivery. Provided is an adjuvanted influenza vaccine formulation, comprising (i) peptidoglycan microparticles obtained from a Gram-positive bacterium and (ii) at least one influenza virus antigen or antigenic preparation thereof, which antigen or antigenic preparation is not fused or otherwise covalently attached to a proteinaceous peptidoglycan binding moiety.

Abstract: A process for producing a split influenza virus preparation or subunit influenza preparation comprising the steps of: (i) providing a whole virus preparation; (ii) splitting the whole virus preparation in the presence of a first detergent; (iii) adding t-octylphenoxypolyethoxyethanol (TRITON X-100™) to the resulting split virus preparation; and (iv) filtering the split virus preparation.

Abstract: Vaccine compositions comprising influenza antigens formulated as nanoparticulate water in oil miniemulsions. The vaccines may be formulated at the point of use and are useful in emergency response conditions.

Abstract: Immunogens and compositions are provided that encode a protein comprising an influenza A subtype H1 hemagglutinin glycan-shielded receptor binding domain A (RBD A) region and at least one influenza A subtype H1 hemagglutinin antigenic site wherein the antigenic site is not within the RBD-A region. Also provided are immunogens and compositions that encode an immunogenic protein comprising at least one epitope of the RBD-A region of a pandemic influenza A subtype H1 hemagglutinin antigen. Also provided are such proteins, nucleic acids that encode such proteins, and antibodies against such proteins. Also provided are methods to use such immunogens and compositions to elicit a neutralizing antibody immune response against influenza A subtype H1 virus.

Abstract: The present invention provides, among other things, methods, reagents, and systems for the treatment, detection, analysis, and/or characterization of influenza infections.

Abstract: The present invention relates to a method for immunostimulation in a mammal which comprises a. administration of at least one mRNA containing a region which codes for at least one antigen of a pathogen or at least one tumour antigen, and b. administration of at least one cytokine, at least one cytokine mRNA, at least one CpG DNA or at least one adjuvant RNA. The invention likewise relates to a product and a kit comprising the mRNA and cytokine or cytokine mRNA or CpG DNA or adjuvant RNA of the invention.