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

Abstract: The present invention discloses and claims virus like particles (VLPs) that express and/or contains seasonal influenza virus proteins, avian influenza virus proteins and/or influenza virus proteins from viruses with pandemic potential. The invention includes vector constructs comprising said proteins, cells comprising said constructs, formulations and vaccines comprising VLPs of the inventions. The invention also includes methods of making and administrating VLPs to vertebrates, including methods of inducing substantial immunity to either seasonal and avian influenza, or at least one symptom thereof.

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

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: 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: 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 invention provides immunomodulatory proteins, e.g., useful to prevent, inhibit or treat microbial infection.

Abstract: A DNA vaccine comprising hyperglycosylated mutant HA gene, which is derived from avian influenza virus, is provided. A DNA vaccine composition comprising: (a) the DNA vaccine; and (b) a booster is also provided. An influenza virus-like particle comprising adjuvant-fused M2 protein is further provided.

Abstract: An affinity-conjugated antigen system (ACAS) comprising one or more antigens conjugated via a plurality of affinity moieties to a papaya mosaic virus (PapMV) or virus-like particle (VLP) derived from the coat protein of PapMV is provided. The affinity moieties are molecules or compounds that are capable of specifically binding to the antigen(s) of interest and which can be attached, for example by chemical or genetic means, to the coat protein of the PapMV or PapMV VLP. The ACAS can optionally further comprise one or more additional antigens, which may be the same as, or different to, the conjugated antigen(s) comprised by the ACAS. Also provided are immunogenic compositions, including vaccines, comprising an ACAS. The immunogenic compositions are useful in the treatment, including prevention, of various diseases and disorders for which a humoral and/or cellular response in the animal is required.

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: Provided herein are methods for generating dry vaccine powder formulations. Dry vaccine powder formulations can be used for intranasal delivery. Also provided are methods for stimulating local mucosal and systemic immunity by intranasal vaccine delivery.

Abstract: The present invention relates to a pharmaceutical vaccine composition comprising: (a) a pathogen-derived antigen selected from the group consisting of Mycobacterium tuberculosis antigen, Bacillus anthracis antigen, HAV (hepatitis A virus) antigen, HBV (hepatitis B virus) antigen, HCV (hepatitis C virus) antigen, HIV (human immunodeficiency virus) antigen, influenza virus antigen, HSV (herpes simplex virus) antigen, Hib (Haemophilus influenzae type b) antigen, Neisseria meningitidis antigen, Corynebacterium diphtheriae antigen, Bordetella pertussis antigen, Clostridium tetani antigen and Varicella virus antigen; (b) a deacylated non-toxic LOS (lipooligosaccharide); and (c) a pharmaceutically acceptable carrier.

Abstract: The invention relates to the use of a trivalent, non-live influenza antigen preparation, particularly a split influenza preparation, in the manufacture of a one-dose influenza vaccine for intradermal delivery. In particular, the invention relates to the use of split influenza preparations wherein the vaccine comprises at least one non-ionic surfactant selected from the group consisting of the octyl-or nonylphenoxy polyoxyethanols (for example the commercially available Triton™ series), polyoxyethylene sorbitan esters (Tween™ series) and polyoxyethylene ethers or esters of general formula (I): HO(CH2CH2O)n-A-R, wherein n is 1-50, A is a bond or —C(O)—, R is C1-50 alkyl or phenyl C1-50 alkyl; and combinations of two or more of these.

Abstract: The present invention relates to a process for stabilizing an adjuvant containing vaccine composition, an adjuvanted vaccine composition in dry form and in particular a process for stabilizing an influenza vaccine composition, particularly an adjuvanted influenza vaccine composition in dry form.

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: Disclosed are compositions and the use of the compositions for protection against pathogens comprising an isolated internal pathogenic protein, a TLR agonist and an aluminum salt.

Abstract: The invention provides monoclonal antibodies and related binding proteins that bind specifically to the envelope glycoprotein of H5 subtypes of avian influenza virus (“AIV”). The monoclonal antibodies and related binding proteins are useful for the detection of H5 subtypes of AIV, including the pathogenic H5N1 subtypes. Virus may be detected in formalin preserved, paraffin embedded specimens as well as frozen specimens and biological fluids. Accordingly, the invention provides for the diagnosis and surveillance of dangerous viral infections.

Abstract: Present invention relates to vaccine formulations and adjuvants for use in e.g. compositions, thereby avoiding the phenomenon of Bell's palsy in a frequency above the natural occurance.

Abstract: Immunogenic compositions and methods for vaccinating humans and animals against enveloped viruses, and more particularly against influenza viruses. Immunogenic compositions are composed of internal moieties of an enveloped virus. Such internal moieties are more highly conserved between different viral strains than are their external moiety counterparts. Consequently, these immunogenic compositions have an increased likelihood of generating immuno-protective responses in humans and animals against enveloped viruses that are strain independent. Methods are also disclosed that increase the ability of the immunogenic compositions to generate immuno-protective responses against their target viruses.

Abstract: A process for preparing a lyophilised vaccine antigen, comprising steps of (i) increasing the concentration of an antigen in a liquid composition including that antigen using centrifugal filtration and/or ultrafiltration, to provide a concentrated antigen, and (ii) lyophilising the concentrated antigen, to provide the lyophilised vaccine antigen. The lyophilised material can be reconstituted and used for vaccine formulation. The process is particularly useful with influenza vaccine antigens.

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: Compositions comprising influenza virosomes comprising reconstituted envelopes of one or more influenza strains are used in vaccine formulations, including intranasal or inhalation formulations, to induce an immune response against one or more influenza strains. The virosomes of the composition are derived entirely from influenza viral particles and comprise the influenza antigen haemagglutinin. No lipid from an external source is added to the virosomes. In addition, no separate adjuvant or immune stimulator is added to the composition.

Abstract: The compound N-(4-{[4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl]oxy}butyl)octadecanamide is a useful drug compound for enhancing immune response and can be used, for example, as a vaccine adjuvant and a cancer treatment.

Abstract: The present application applies to the field of veterinary vaccines, in particular of vaccines for poultry against avian influenza. The vaccine is based on a recombinant viral vector expressing the haemagglutinin protein of an influenza virus, wherein the vector is herpes virus of turkeys (HVT) and the haemagglutinin gene is driven by a glycoprotein B gene promoter from a mammalian herpesvirus. A vaccine comprising this HVT+HA vector can be used to induce a protective immune response against avian influenza in poultry, and to reduce the spread of AIV. The invention also relates to methods, uses, and vaccines involving the HVT+HA vector.

Abstract: The present invention discloses a unique kit for providing a combinational therapeutic product comprising a medical device and a pharmaceutical composition to treat mammal diseases. The medical device is to meet these unmet needs of cleansing out these harmful substances, such as viruses, multiple drug resistant bacteria, fungi, pollen, dusts, or excessive mucus. The pharmaceutical composition adds the required functions of anti-inflammatory, anti-allergy, anti-cancer, promoting membrane healing or immunomodulating, to have the added effect of the medical device. The method of using the combinational product is also disclosed. The new product can be used to prevent and treat a variety of diseases, such as common cold, drug resistant influenza, sinusitis, post nasal drip, virus-triggered asthma, or chronic obstructive pulmonary disease. In addition, the new kit and the process of use are safe and cost effective.

Abstract: An improved method for preparing squalene from a squalene-containing composition, said method comprising the steps of (a) a purification distillation carried out at a temperature T1; (b) a denaturing distillation carried out at a temperature T2; wherein steps (a) and (b) may be performed in either order; T1 and T2 are sufficient to cause squalene to boil; T2>T1; and T2>200° C.

Abstract: The present invention provides vectors that contain and co-express in vivo or in vitro immunogenic polypeptides or antigens together with an OX40L polypeptide, which functions as a genetic adjuvant. Together, the immunogenic polypeptide and the OX40L polypeptide elicit an immune response in animal or human, which is greater than the immune response elicited by the immunogenic polypeptide alone.

Abstract: Universal flu vaccines are disclosed. The vaccines induce broad and sustained protection against a wide range of influenza A viruses, reduce the need for annual vaccination campaigns with vaccines based upon viral strains predicted to be the predominant circulating strains, and ameliorate the threat of future pandemics that can potentially kill millions.

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: The present invention discloses and claims virus like particles (VLPs) that express and/or contains seasonal influenza virus proteins, avian influenza virus proteins and/or influenza virus proteins from viruses with pandemic potential. The invention includes vector constructs comprising said proteins, cells comprising said constructs, formulations and vaccines comprising VLPs of the inventions. The invention also includes methods of making and administrating VLPs to vertebrates, including methods of inducing substantial immunity to either seasonal and avian influenza, or at least one symptom thereof.

Abstract: The present invention includes a composition including as one component a slurry matrix that is a liquid at room temperature and a gel at physiological pH, physiological salt concentrations and/or physiological temperatures and as a second component one or more antigens. Also include are methods of inducing an immune response in a subject and vaccinating a subject by administering such compositions.

Abstract: A novel influenza C virus with only low homology to any influenza C virus previously characterized. Challenge studies show that the virus can infect pigs and be transmitted between pigs. Additionally, influenza C is commonly thought of as a human pathogen and serological studies have been performed, looking at the incidence of antibodies against this virus in both pigs and humans. Approximately 10% of pigs and 30% of humans have antibodies to this virus. Additional experimental data show that the virus can infect and transmit in ferrets (a surrogate for human infection studies). In a third aspect, the present invention is the partial genome of this novel influenza C virus. In another aspect, the present invention is a method of detection in animals of this novel influenza C virus.

Abstract: A method and system are disclosed for identifying and/or locating complex patterns in an amino acid sequence stored in a computer file or database. According to an aspect of the present invention, techniques are provided to facilitate queries of protein databases. For protein descriptions received in response to the queries, embodiments of the present invention may scan the received protein descriptions to identify and locate Replikin patterns. A Replikin pattern is defined to be a sequence of 7 to about 50 amino acids that include the following three (3) characteristics, each of which may be recognized by an embodiment of the present invention: (1) the sequence has at least one lysine residue located six to ten amino acid residues from a second lysine residue; (2) the sequence has at least one histidine residue; and (3) at least 6% of the amino acids in the sequence are lysine residues.

Abstract: The invention thus relates to a method for boosting the efficiency of a vaccine by co-administering a probiotic bacterium such as L. casei 431 or BB-12 with an influenza vaccine. The invention further relates to a composition for use in such a treatment.

Abstract: This invention provides methods and compositions to preserve bioactive materials in a dried foam matrix. Methods provide non-boiling foam generation and penetration of preservative agents at temperatures near the phase transition temperature of the membranes.

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

Abstract: Described is an immunostimulatory oligodeoxynucleic acid molecule (ODN) having the structure according to formula (I), wherein any NMP is a 2? deoxynucleoside monophosphate or monothiophosphate, selected from the group consisting of deoxyadenosine-, deoxyguanosine-, deoxyinosine-, deoxycytosine-, deoxyuridine-, deoxythymidine-, 2-methyl-deoxyinosine-, 5-methyl-deoxycytosine-, deoxypseudouridine-, deoxyribosepurine-, 2-amino-deoxyribosepurine-, -6-S-deoxyguanine-, 2-dimethyl-deoxyguanosine- or N-isopentenyl-deoxyadenosine-monophosphate or -monothiophosphate, NUC is a 2? deoxynucleoside, selected from the group consisting of deoxyadenosine-, deoxyguanosine-, deoxyinosine-, deoxycytosine-, deoxyuridine-, deoxythymidine-, 2-methyl-deoxyinosine-, 5-methyl-deoxycytosine-, deoxypseudouridine-, deoxyribosepurine-, 2-amino-deoxyribosepurine-, 6-S-deoxyguanine-, 2-dimethyl-deoxyguanosine- or N-isopentenyl-deoxyadenosine, any X is O or S, a and b are integers from 0 to 100 with the proviso that a+b is between 4 and 150,

Abstract: A sensor chip for detecting an immune response against an influenza virus, the sensor chip including a substrate having a surface and a plurality of hemagglutinin polypeptides bound to discrete locations on the surface of the substrate, each hemagglutinin polypeptide having a hemagglutinin epitope. Detection devices containing the sensor chip and methods of detecting influenza immune responses are also described herein.

Abstract: Bacterial immunity proteins are utilized to increase immune response to an antigen of interest.

Abstract: Described in this application are attenuated strains of avian influenza virus containing temperature sensitive mutations in addition to a genetic tag in the PB1 gene. The attenuated viruses are useful as avian and mammalian vaccine for protective immunity against homologous and heterologous lethal challenges with influenza virus. A genetically modified avian influenza virus backbone is described which can be used as a master donor strain for the generation of live attenuated vaccines for epidemic and pandemic influenza.

Abstract: This disclosure demonstrates a novel therapy immunological approach using polyamine-based therapy (PBT) for relieving tumor-induced suppression of the patient's immune system. The demonstration of the pharmacological release from the naturally occurring polyamine-mediated immune suppression offers profound impact on the immunotherapy of cancer together with a variety of diseases caused by the disease-causing vector's ability to evade an immune reaction. This therapeutic approach is equally applicable to disease states whereby immune system suppression by polyamines has been demonstrated including; bacterial infections, parasitic infections including malaria and typanosomiasis, viral infections, peptic ulcers and gastric cancer due to H. Pylori infection together with prevention of pregnancy. With a small molecule drug, used in combination with DFMO, the pharmacological manipulation of polyamine levels for therapeutic benefit in various disease states is possible.

Abstract: An isolated influenza B virus which has reduced sensitivity to one or more neuraminidase (NA) inhibitors, wherein the reduced sensitivity to one or more NA inhibitors is associated with a residue in NA other than Ile at position 222, a residue in NA other than Ser at a position 250, or a residue in NA other than Gly at position 402, as well as methods to detect such a virus or determine agents that inhibit the infection or replication of such as virus, are provided.

Abstract: The present invention is directed to mammalian bi-specific T cells and methods for using these bi-specific T cells. More specifically, the invention relates to a method of controlling administration of cancer antigen to a subject by providing bi-specific T cells that express a viral antigen T cell receptor and a cancer antigen-specific chimeric receptors and triggering their activation by also administering antigen-presenting T-cells which express viral antigen. These bi-specific T cell clones are a source of effector cells that persist in vivo in response to stimulation with viral antigen, leading to long-term function after their transfer to patients with cancer and autoimmune diseases.

Abstract: The present invention provides novel human anti-influenza antibodies and related compositions and methods. These antibodies are used in the diagnosis and treatment of influenza infection.

Abstract: The present invention relates to the use of a therapeutically effective amount of abscisic acid (ABA) or its analogs to treat or prevent inflammation induced by exposure to lipopolysaccharide (LPS) or respiratory inflammation. The invention also relates to methods and composition for enhancing vaccine efficacy using ABA.

Abstract: An improved method for the manufacture of an oil-in-water emulsion involves circulation of emulsion components between a first container and a second container via a homogenizer and/or via a microfluidization device. Usefully, all of the emulsion components from the first container are emptied before being returned.

Abstract: An improved method for the manufacture of an oil-in-water emulsion involves three procedures: (i) preparation of a preliminary emulsion; (ii) micro fluidization of the preliminary emulsion to reduce its droplet size; and (iii) filtration of the microfluidized emulsion through a hydrophilic membrane. The emulsions are useful as vaccine adjuvants.

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: A vaccine containing a H1 subtype influenza A virus hemagglutinin is either unadjuvanted or is adjuvanted but not with an oil-in-water emulsion adjuvant. The vaccine is suitable for immunizing a patient against swine flu. The vaccine may be monovalent. The vaccine may include two different H1 subtype influenza A virus hemagglutinins, wherein (i) the first H1 subtype influenza A virus hemagglutinin is more closely related to SEQ ID NO: 1 than to SEQ ID NO: 3 and (ii) the second H1 subtype influenza A virus hemagglutinin is more closely related to SEQ ID NO: 3 than to SEQ ID NO: 1. A monovalent vaccine may be administered in conjunction with a trivalent A/H1N1-A/H3N2 B seasonal influenza vaccine. Other embodiments are also disclosed, such as reassortant viruses.

Abstract: A live attenuated influenza vaccine contains a H1 subtype influenza A strain. Its hemagglutinin is more closely related to SEQ ID NO: 1 than to SEQ ID NO: 3.