Abstract: The present invention relates to an influenza antigen, comprising a fusion product of at least the extracellular part of a conserved influenza membrane protein or a functional fragment thereof and a presenting carrier, which may be a presenting (poly)peptide or a non-peptidic structure, such as glycans, peptide mimetics, synthetic polymers. The invention further relates to a vaccine against influenza, comprising at least an antigen of the invention, optionally in the presence of one or more excipients. The invention also relates to use of the antigen, a method for preparing the antigen and acceptor cells expressing the antigen.

Abstract: The present invention relates to an influenza antigen, comprising a fusion product of at least (1) the extracellular part of a conserved influenza membrane protein (e.g., M2) or a functional equivalent thereof and (2) a presenting carrier. The presenting carrier may be a (poly)peptide or a non-peptidic structure such as glycans, peptide mimetics, and synthetic polymers. The invention further relates to methods of making and using the antigen, and to influenza vaccines comprising the antigen and optionally one or more excipients.

Abstract: The invention relates to virosome-based influenza vaccines for the manufacture of medicaments that are administered intradermally in humans. The invention provides (trivalent) compositions comprising low doses of hemagglutinin (HA) antigen in a virosomal preparation that fulfill the immune response standards with respect to seroconversion rates, GMT-fold increase and protection rates, for use in vaccination set-ups.

Abstract: The invention encompasses compositions and methods relating to viral polymerases having one or more substitutions of different amino acids at conserved regions of the polymerase yields enzymes with varying rates and fidelity of replication. A universally applicable, polymerase-mechanism-based strategy for production of attenuated viruses and anti-viral vaccines is disclosed. Attenuated viruses serve as vaccines and were shown to provide protection against poliovirus challenge in vivo.

Abstract: The present invention relates to providing new vaccines and treatments for the diseases related to canine influenza virus. It discloses influenza viral antigens, and methods of presenting these antigens to canines, especially dogs. It relates to attenuated and killed vaccines. The present invention relates to experimentally generated canine and equine influenza viruses. The invention also includes influenza A, including H3, N8, H3N8, H7N7 and viruses which contain at least one genome segment from an canine or equine influenza virus. The present invention also relates to the use of these viruses in therapeutic compositions to protect canines, dogs in particular, from diseases caused by influenza viruses.

Abstract: The present invention relates to the use of lipid containing particles, such as liposomes, iscom and/or iscom matrix and posintros, comprising at least one lipid and at least one saponin for the preparation of a pharmaceutical for the treatment of cancer. The saponins are preferably from Quillaja Saponaria Molin. Further, the particles are also delivery systems for one or several compounds for cancer treatment with complementary mechanisms. More, the invention discloses kit of parts comprising at least two parts, wherein one part comprising at least one saponin fraction which is hydrophobic having a killing effect on cancer cell; and the other part comprising at least one saponin fraction which is comparatively hydrophilic, stimulating and modulating the immune response.

Abstract: An elongate body for parenteral injection at low velocity from a device is described. The body has at least one pointed end and comprises at least one active material. In addition, the body has a compressive strength of greater than or equal to 5 Newton and the pointed end has an included angle of between about 10-50°. A solid vaccine formulation for needle-free parenteral delivery, methods for making the body, packaging of the body and use of the body, packaging and suitable delivery device are also described.

Abstract: The present invention relates to a method for replicating poxviruses such as vaccinia virus comprising the steps of inoculating avian embryonic stem cells with viral particles and culturing said cells in a basal medium until cells lysis occurs and newly produced viral particles are released in said medium.

Abstract: The present invention provides novel MDCK-derived adherent non-tumorigenic cell lines that can be grown in the presence or absence of serum. The cell lines of the present invention are useful for the production of vaccine material (e.g., viruses). More specifically, the cell lines of the present invention are useful for the production of influenza viruses in general and ca/ts influenza viruses in particular. The invention further provides methods and media formulations for the adaptation and cultivation of MDCK cells such that they remain non-tumorigenic. Additionally, the present invention provides methods for the production of vaccine material (e.g., influenza virus) in the novel cell lines of the invention.

Abstract: Certain embodiments disclosed herein relate to compositions, methods, devices, systems, and products regarding frozen particles. In certain embodiments, the frozen particles include materials at low temperatures. In certain embodiments, the frozen particles provide vehicles for delivery of particular agents. In certain embodiments, the frozen particles are administered to at least one biological tissue.

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: Compositions and methods for preventing and treating influenza virus infections are provided. Compositions include novel immunogenic compositions having at least one vector capable of expressing an antigenic component from four or more influenza viruses representative of the antigenic diversity of a target population of influenza virus strains. Compositions further include novel immunogenic compositions having at least four vectors, each vector capable of expressing a single antigenic component representative of the antigenic diversity of a target population of influenza virus strains. In other aspects of the invention, the immunogenic compositions also include one or more viral proteins (or antigenic portions thereof), or one or more live attenuated viruses, derived from the target population of influenza virus strains. The invention further provides methods for making a multi-valent influenza vaccine and methods for inducing an immune response in a subject against influenza viruses.

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

Abstract: The present disclosure generally relates to a composition comprising one or more peptides selected from influenza virus antigenic peptides M2e, HA0, BM2 and a M2e-BM2 fusion peptide in a composition with a cationic liposome delivery vehicle, and the use of these compositions as a universal vaccine against influenza A and/or B viral strains.

Abstract: Compositions are provided which include hyaluronic acid derivatives in combination with vaccine antigens, and optionally adjuvants, for mucosal delivery. Also provided are methods of making the compositions, as well as methods of immunization using the same.

Abstract: The present invention relates to the engineering of recombinant influenza viruses that express tumor-associated antigens. Expression of tumor-associated antigens by these viruses can be achieved by engineering specific epitopes into influenza virus proteins, or by engineering viral genes that encode a viral protein and the specific antigen as independent polypeptides. Tumor-bearing patients can be immunized with the recombinant influenza viruses alone, or in combination with another treatment, to induce an immune response that leads to tumor reduction. The recombinant viruses can also be used to vaccinate high risk tumor-free patients to prevent tumor formation in vivo.

Abstract: The invention relates to the method for evaluating the potential of a chemical entity, such as an antibody, to bind to a peptide epitope derived from the divalent sialoside binding site of hemagglutinin protein of influenza virus. The invention also provides peptide epitopes 5 for use in the prevention and/or treatment of influenza or for the development of such treatment or vaccine against influenza.

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: The present invention provides for a novel oil-in-water (O/W) emulsion, with increased stability in the presence of bacterial or viral suspensions, especially those concentrated and non-purified or weakly purified. The emulsion of the present invention can act as vehicle for the delivery of a pharmaceutical composition comprising at least one immunogen and, in particular, an immunogen selected from the group comprising an inactivated pathogen, an attenuated pathogen, a subunit, a recombinant expression vector, and a plasmid or combinations thereof.

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: This invention is directed to a vaccine and a method for using the vaccine to protect a feline from influenza virus infection. The vaccine comprises one or more antigens from one or more H3, N8, H7 or N7-type influenza viruses.

Abstract: The invention provides proteins from Staphylococcus aureus, including amino acid sequences and corresponding nucleotide sequences. The proteins are useful for vaccines, immunogenic compositions, diagnostics, enzymatic studies, and as targets for antibiotics.

Abstract: Briefly described, virosomes, methods of preparing virosomes, immunogenic compositions that include virosomes, and methods of eliciting an immune response using immunogenic compositions that include virosomes are described herein. A virosome can include at least one viral surface envelope glycoprotein expressed on the surface of the virosome. The virosome can also optionally include at least one adjuvant molecule expressed on the surface of the virosome.

Abstract: It is intended to provide a low molecular weight adjuvant which can be administered safely without inducing skin irritation or the like by transdermal or transmucosal administration and is for enhancing immunogenicity of an antigen efficiently. It can be achieved by an immunostimulant adjuvant containing at least one substance selected from the group consisting of aliphatic alcohols, free fatty acids and fatty acid derivatives but does not contain a substance represented by the following formula. (In the formula, R3 and R4 may be combined to form a cyclic ring, and R1 and R2 independently represent an alkyl side chain having 1 to 16 carbon atoms.

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

Abstract: The present invention relates to a stabiliser composition comprising an amino acid, and a sugar wherein all compounds are chemically defined; to a vaccine composition comprising such a stabiliser composition and a biological molecule and/or a micro-organism; to a method for preparing a pharmaceutical composition comprising admixing such a stabiliser composition with a biological molecule and/or a micro-organism; to the use of such a stabiliser composition, and of vaccines prepared therewith.

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 use of poly(lactide) or poly(lactide-co-glycolide) microparticles with adsorbed antigen is disclosed. The microparticles are useful for enhancing CTL responses to a selected antigen.

Abstract: The present invention relates to adenovirus-based vaccines against avian influenza viruses with pandemic potential. The present invention provides replication-defective adenoviral vectors, each having a nucleic acid encoding an influenza A polypeptide. When introduced into a subject, the expressed influenza A polypeptide induces the production of antibodies that bind to influenza. The present invention also provides methods for inducing an immune response in a subject. Subjects are administered a replication-defective adenoviral vector, wherein the vector has a nucleic acid encoding an influenza A polypeptide. When the vector is expressed in the subject, the influenza A polypeptide induces the subject to produce antibodies to influenza.

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: A purpose of the present invention is to provide a vaccine for in ovo inoculation effective for prevention of any fowl viral diseases. A fowl vaccine for in ovo inoculation with high efficacy in view of safety as well wherein, by holding such live viruses on a virus-adsorbing agent through adsorption that have been difficult for practical usage as a vaccine for in ovo inoculation, viral growth in embryonated chicken eggs after in ovo inoculation is retarded to thereby reduce pathogenicity of the viruses to embryo to avoid reduction in hatching rate and to alleviate severity in clinical symptoms after hatching. A virus-adsorbing agent to be used in the vaccine includes an aluminum compound such as aluminum hydroxide gel, potassium alum and the like.

Abstract: The present invention provides a novel transfer vector and a recombinant baculovirus; methods for the production thereof; pharmaceuticals containing the recombinant baculovirus as an active ingredient, which are useful as preventive or therapeutic drugs for infectious diseases such as malaria and influenza; and methods for preventing and treating infectious diseases such as malaria and influenza. More specifically, the invention provides a recombinant transfer vector capable of expressing a foreign gene fused to a virus gene under the control of a dual promoter; a recombinant baculovirus; methods for the production thereof; pharmaceuticals containing the recombinant baculovirus as an active ingredient; and methods for preventing and treating infectious diseases such as malaria and influenza comprising administrating the recombinant baculovirus to patients.

Abstract: Means and methods for producing mammalian viruses, the method comprising infecting a culture of immortalized human cells with a virus, incubating the culture infected with virus to propagate the virus under conditions that permit growth of the virus, and to form a virus-containing medium, and removing the virus-containing medium. The viruses can be harvested and be used for the production of vaccines. Advantages include that human cells of the present invention can be cultured under defined serum-free conditions and the cells show improved capability for propagating virus. Methods are provided for producing, in cultured human cells, influenza virus and vaccines derived thereof. This method eliminates the necessity of using whole chicken embryos for the production of Influenza vaccines. The method also provides for the continuous or batch-wise removal of culture media. As such, the present invention allows the large-scale continuous production of viruses to a high titer.

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 present invention describes chimeric vaccine antigens against the avian influenza virus (AIV). Said vaccine antigens are based on viral subunits that are coupled to protein molecules that stimulate not only the cellular but also the humoral immune system. The chimeric antigens may be produced in expression systems that guarantee correct three-dimensional folding of the chimeric molecules that constitute the basis of the present invention. The vaccine compositions that contain said chimeric antigens induce a potent, early immune response both in birds and in vaccinated mammals, stimulating high haemagglutinin-inhibiting antibody titres and a potent specific cellular response against the viral antigen. The chimeric antigens, and also the resulting vaccine compositions, are applicable to the field of human and animal health as vaccines for preventive use.

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 methods for inducing an immune response to influenza in a subject comprising administering a nanoemulsion vaccine composition comprising an influenza immunogen or protein.

Abstract: The invention relates to immunogenic compositions containing CD1d ligands that induce long-term immunological memory in the absence of booster doses and/or in the absence of multiple priming doses. The invention further relates to immunogenic compositions containing CD1d ligands and antigens from influenza virus, group B streptococcus and serogroup B meningococcus.

Abstract: The present invention relates to immunogenic compositions for intradermal delivery of an antigenic or immunogenic agent in combination with one or more excipients. The immunogenic compositions of the invention comprise an antigenic or immunogenic agent and at least one excipient which acts as an adjuvant, i.e., enhances the immune response to the antigenic or immunogenic agent, once delivered to the intradermal compartment of a subject's skin. The immunogenic compositions of the invention comprise an excipient which when administered to the intradermal compartment of skin in accordance with the invention demonstrate adjuvant activity. The immunogenic compositions of the invention have enhanced efficacy as the excipients of the composition cause an asymptomatic skin irritation and recruit antigen presenting cells to the intradermal compartment and thus enhance presentation and/or availability of the antigenic or immunogenic agent to the antigen presenting cells.

Abstract: Influenza vaccines with oil-in-water emulsion adjuvants are known. The amount of emulsion adjuvant required for an influenza vaccine can be reduced, thereby allowing more vaccines to be made from a given amount of emulsion, and/or minimizing the amount of emulsion that has to be produced for a given number of vaccine doses. These vaccines can conveniently be made by mixing (i) an oil-in-water emulsion and (ii) an aqueous preparation of an influenza virus antigen. In one aspect, substantially equal volumes of components (i) and (ii) are used; in another aspect, an excess volume of component (ii) is used. When using substantially equal volumes, component (ii) has a hemagglutinin concentration of more than 60 ?g influenza virus strain per ml. Components (i) and (ii) can be presented in kit form.

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: The present invention provides materials and methods to facilitate the pulmonary delivery of therapeutic agents. In some embodiments, agonists of tight junctions (e.g., zonulin agonists) are used in compositions to facilitate the uptake of therapeutic agents from the pulmonary mucosa.

Abstract: Measurements of the squalene content in oil-in-water emulsions can be used as a way of checking for problems during production. In particular, it has been found that a drop in squalene content can indicate that filtration problems occurred. Testing the squalene content in the final lots is easier than investigating the characteristics of the filter, and so a squalene assay simplifies the quality control of oil-in-water emulsions.

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 is provided for identifying, isolating, and producing htrB mutants of gram-negative bacterial pathogens. The method comprises mutating the htrB gene of a gram-negative bacterial pathogen so that there is a lack of a functional htrB protein, resulting in a mutant that lacks one or more secondary acyl chains contained in the wild type gram-negative bacterial pathogen, and displays substantially reduced toxicity as compared to the wild type strain. Also, the present invention provides methods for using a vaccine formulation containing the htrB mutant, the endotoxin isolated therefrom, or the endotoxin isolated therefrom which is then conjugated to a carrier protein, to immunize an individual against infections caused by gram-negative bacterial pathogens by administering a prophylactically effective amount of the vaccine formulation.

Abstract: A problem with stockpiling influenza vaccines is their short shelf life. Storage volume is another problem. The invention prepares and stockpiles bulk vaccine, and the bulk is stored under frozen conditions. Compared to final vaccine, the higher antigen concentration and absence of packaging materials (boxes, vials, etc.) in the bulk means that the storage space requirements are hugely reduced. A process for preparing an influenza vaccine bulk thus comprises the steps of: (a) preparing bulk vaccine antigen from a source of influenza virus; and (b) storing the bulk vaccine prepared in step (a) under frozen conditions.

Abstract: Use of a polyamino acid as an adjuvant; an application of a polyamino acid as an adjuvant in the production of a vaccine; a vaccine comprising a polyamino acid as an adjuvant; a biodegradable nanoparticle having a virus antigen immobilized thereon; and a vaccine comprising the biodegradable nanoparticle.

Abstract: Vaccines directed against antigens such as membrane proteins from pathogens or tumor cells are disclosed. Also described are methods of forming reconstituted viral membranes, with membrane fusion activity, which are lipid bilayer membranes preferably containing natural lipids of a virus, a viral fusion protein, one or more optional further antigens as well as amphiphilic adjuvants. Pharmaceutical compositions including such reconstituted viral membranes are also described.

Abstract: This invention provides virosome preparations from an enveloped virus, in particular from influenza virus, containing from said virus, and a saponin adjuvant. In particular the invention provides a virosome preparation from influenza virus an influenza antigen a QS21, optionally with a sterol. The invention also provides vaccine compositions containing said virosome preparations, methods of preparing said virosome preparations and vaccine containing them.

Abstract: The present invention relates to monovalent influenza vaccine formulations and vaccination regimes for immunising against influenza disease, their use in medicine, in particular their use in augmenting immune responses to various antigens, and to methods of preparation. In particular, the invention relates to monovalent influenza immunogenic compositions comprising an influenza antigen or antigenic preparation thereof from an influenza virus strain being associated with a pandemic outbreak or having the potential to be associated with a pandemic outbreak, in combination with an oil-in-water emulsion adjuvant comprising a metabolisable oil, a sterol or a tocopherol such as alphatocopherol, and an emulsifying agent.