Abstract: A protein (xylanase) has been identified that produces a strong immune response in pigs when added to a vaccine. The protein is added to vaccines at a particular concentration. The protein is delivered to the animal as part of the vaccine and elicits an immune reaction (antibodies are generated by the animal against the compliance marker protein). The antibodies are then detected in sera samples by a diagnostic test, enzyme-linked immunosorbent assay (ELISA). In the ELISA compliance marker assay, the marker protein (antigen) in coated onto polystyrene plates and is used to detect antibodies against the marker in sera samples. This combination of marker protein added to vaccines and the ELISA to detect antibodies raised against the marker protein can be used to determine whether a particular animal(s) has been vaccinated. The selected protein is commercially-available, identified as Generally Recognized as Safe by the FDA, and does not cause adverse reactions in animals.

Abstract: Described herein are compositions and methods for stimulating an immune response to one or more proteins derived from one or more respiratory pathogens. In particular, the invention relates to alphavirus replicons, alphavirus vector constructs, alphavirus replicon particles expressing one or more antigens derived from one or more respiratory pathogens as well as to method of making and using these immunogenic compositions.

Abstract: The invention relates to influenza virus vaccines, and in particular to a reassortant influenza virus which has at least its hemagglutinin gene derived from a non-pathogenic or low pathogenic influenza virus, and its other genes derived from a donor strain. In one embodiment the influenza virus is a 7:1 reassortant, in which only the hemagglutinin gene is derived from a non-pathogenic influenza virus. The virus is useful for production of vaccines against influenza, including influenza caused by highly pathogenic influenza virus strains.

Abstract: The present invention is an improved method for the production of vaccines to transmittable viral pathogens where the virus is pathogenic to the chicken embryos. Bird embryos are selected for vaccine production from wild and domestic birds, and preferably waterfowl, that have increased resistant to the viral pathogen. The invention is useful for native and engineered viruses.

Abstract: Disclosed are novel methods for combating diseases characterized by deposition of amyloid. The methods generally rely on immunization against amyloidogenic proteins (proteins contributing to formation of amyloid) such as beta amyloid (A?). Immunization is preferably effected by administration of analogues of autologous amyloidogenic polypeptides, said analogues being capable of inducing antibody production against the autologous amyloidogenic polypeptides. Especially preferred as an immunogen is autologous A? which has been modified by introduction of one single or a few foreign, immunodominant and promiscuous T-cell epitopes while substantially preserving the majority of A?'s B-cell epitopes. Also disclosed are nucleic acid vaccination against amyloidogenic polypeptides and vaccination using live vaccines as well as methods and means useful for the vaccination.

Abstract: A human synthetic peptide-based influenza vaccine for intranasal administration comprises a mixture of flagella containing at least four epitopes of influenza virus reactive with human cells, each expressed individually in Salmonella flagellin, said influenza virus epitopes being selected from the group consisting of: (i) one B-cell hemagglutinin (HA) epitope; (ii) one T-helper hemagglutinin (HA) or nucleo-protein (NP) epitope that can bind to many HLA molecules; and (iii) at least two cytotoxic lymphocyte (CTL) nucleoprotein (NP) or matrix protein (M) epitopes that are restricted to the most prevalent HLA molecules in different human populations.

Abstract: Methods and compositions for the optimization and production of influenza viruses, e.g., ca influenza B strains, in eggs and host cells suitable as influenza vaccines are provided.

Abstract: Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modern techniques grow the virus in mammalian cell culture e.g. on Vero, MDCK or PER.C6 cell lines. The inventor has realised that the conditions used for influenza virus 5 culture can increase the risk that pathogens other than influenza virus may grow in the cell lines and have identified specific contamination risks. Suitable tests can thus be performed during manufacture in order to ensure safety and avoid iatrogenic infections.

Abstract: The present invention relates to influenza vaccine formulations and vaccination regimes for immunising against various diseases. In particular the invention relates to vaccine formulations comprising an oil-in-water emulsion adjuvant and 3D-MPL, their use in medicine, in particular their use in augmenting immune responses to various antigens, and to methods of preparation, wherein the oil-in-water emulsion comprises a sterol, a metabolisable oil and an emulsifying agent.

Abstract: Attenuated influenza virus variants comprising substitutions in NS1 that interfere with viral replication and phosphatidylinositol 3-kinase activation are described. NS1 variant polypeptides, polynucleotides encoding NS1 variant polypeptides, a reverse genetics system for producing attenuated influenza virus NS1 variants, immunogenic compositions comprising live attenuated influenza virus NS1 variants, methods of stimulating an immune response against influenza virus, methods of interfering with influenza virus replication, and methods of treating and preventing influenza virus infection are described.

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

Abstract: The invention relates to a simple and efficient process for isolating viruses from various sources and for producing live attenuated influenza vaccines in a serum-free Vero cell culture under conditions where alterations in the surface antigens of the virus due to adpative selection are minimized or prevented. The process does not require purification of the virus-containing supernatant harvested from the cell culture nor post-incubation treatment of the viruses for HA activation. The invention further relates to influenza A and B master strain candidates and to vaccines made thereof.

Abstract: The invention seeks to avoid components in split vaccines that could cause an excessive Th2 response. Thus the invention provides an immunogenic composition comprising a split influenza virus antigen and a Th1 adjuvant, wherein the antigen is preferably prepared from a virus grown in cell culture (e.g., it is free from egg proteins).

Abstract: A non-toxic mucosal adjuvant is provided which may be admixed with further antigens to provide a vaccine administrable to mucosal surfaces in organisms including man. Preferably, the non-toxic mucosal adjuvant is a detoxified mutant of a bacterial ADP-ribosylating toxin, optionally comprising one or more amino acid additions, deletions or substitutions.

Abstract: The present invention relates to influenza vaccine formulations and vaccination regimes for immunising against influenza disease. In particular the invention relates to vaccine formulations comprising an oil-in-water emulsion adjuvant and optionally 3D-MPL, their use in medicine, in particular their use in augmenting immune responses to influenza antigens, and to methods of preparation, wherein the oil in water emulsion comprises a sterol, a metabolisable oil and an emulsifying agent. The present invention also provides for new prime-boost vaccination regimes for immunising humans against influenza disease, and in particular for ensuring and ameliorating the immunre response to the booster administration, in which a first influenza virus vaccine is administered in the presence of an adjuvant.

Abstract: The inventions is drawn towards vectors and methods useful for preparing genetically transformed plant cells that express immunogens from pathogenic organisms which are used to produce immunoprotective particles useful in vaccine preparations. The invention includes plant optimized genes that encode the HN protein of Newcastle Disease Virus. The invention also relates to methods of producing an antigen in a transgenic plant.

Abstract: The present invention provides methods of identifying lethal, virulent and rapidly replicating viruses, organisms, and malignancies comprising comparing Replikin concentrations among different viruses, organisms, or malignancies. The present invention further provides isolated Replikin Peak Genes associated with increased lethality, virulence and rapid replication, for diagnostic, therapeutic and predictive purposes.

Abstract: Influenza viruses have traditionally been administered by intramuscular injection. The invention is based on the idea of using alternative routes of delivery for influenza vaccines, more specifically routes that do not require as large a dose of antigen. Delivery of influenza antigen to the Langerhans cells is the route of choice according to the invention. This route has been found to be particularly useful for vaccinating patients who are naive to influenza virus (i.e. have not previously mounted an immune response to an influenza virus), which means that it is advantageous for immunising young children.

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

Abstract: The present invention provides experimentally-generated cold-adapted equine influenza viruses, and reassortant influenza A viruses comprising at least one genome segment of such an equine influenza virus, wherein the equine influenza virus genome segment confers at least one identifying phenotype of the cold-adapted equine influenza virus, such as cold-adaptation, temperature sensitivity, dominant interference, or attenuation. Such viruses are formulated into therapeutic compositions to protect animals from diseases caused by influenza A viruses, and in particular, to protect horses from disease caused by equine influenza virus. The present invention also includes methods to protect animals from diseases caused by influenza A virus utilizing the claimed therapeutic compositions.

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: 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: A method for processing immuno-competent cells in view of an antiviral therapy on a human or animal subject, includes: a step for collecting immuno-competent cells on the human or animal subject, and a step for processing the collected immuno-competent cells, so as to stimulate at least a part of the immuno-competent cells, by presenting a muted viral particle to the cells, in view of a reinjection of the stimulated cells into the human or animal subject.

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

Abstract: The present invention is concerned with vaccinating equines against the equine influenza virus (EIV). It has now been found that adequate protection against equine influenza in equines can be achieved when vaccination with a live equine influenza vaccine (prime) is followed by vaccination with an inactivated influenza vaccine (boost), wherein the two shots are given no longer than 8 weeks apart. The present invention therefore provides a method for vaccination of animals against equine influenza, wherein an animal is first vaccinated with a (prime) vaccine comprising an attenuated equine influenza virus, followed by a vaccination with a (boost) vaccine comprising an inactivated equine influenza virus, and wherein the boost vaccine is administered no longer than eight weeks after the prime vaccine. Preferably the two shots are given no longer than 8 weeks apart, for example, between 3-6 weeks apart, preferably between 4-6 weeks apart.

Abstract: The invention relates to the field of influenza virus and the vaccination against flu. The invention provides a conditionally defective influenza virus particle having seven different influenza nucleic acid segments. The invention also provides a conditionally defective influenza virus particle lacking an influenza nucleic acid segment selected from the group of segments essentially encoding acidic polymerase (PA), the basic polymerase 1 (PB1) and the basic polymerase 2 (PB2). In particular, the invention provides defective influenza virus particles having seven different influenza nucleic acid segments and lacking an influenza nucleic acid segment essentially encoding acidic polymerase.

Abstract: Cationic liposomes with entrapped polynucleotide in the intravesicular space are described. The liposomes include cationic components such as cationic lipids such as DOTAP. Preferably the method of forming liposomes uses the dehydration-rehydration method in the presence of the polynucleotide. The polynucleotide preferably operatively encodes an antigen capable of eliciting a desired immune response, that is, is a gene vaccine.

Abstract: Improved forms of vaccines which comprise proteosomes and protein antigens are described. Vaccines which contain influenza HA as the antigen are used for illustration as to demonstrate efficacy. Improvements in the preparation of the vaccines themselves and the proteosome component are also included.

Abstract: The invention provides a vaccine for protecting a human patient against infection by a human influenza virus strain, wherein the vaccine comprises an antigen from an avian influenza virus strain that can cause highly pathogenic avian influenza. The antigen can invoke an antibody response in the patient that is capable of neutralising said human influenza virus strain. Whereas the prior art used known non-pathogenic avian strains to generate antibodies in humans against known pathogenic avian strains, the invention uses known pathogenic avian strains to protect against emerging pathogenic human strains. Furthermore, whereas the prior art focused on achieving a close antigenic match between the vaccine strain and the target strain, the invention selects vaccine strains based on their pathogenicity, regardless of any perceived close antigenic relationship to the target strain.

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 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. 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 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: The present invention provides methods for identifying a class of peptides referred to as replikins and methods of using replikins to stimulate the immune system of a subject. The method of identifying replikin peptides is based on identifying amino acid sequences comprising 7 to about 50 amino acids that contain (1) at least one lysine residue located six to ten residues from a second lysine residue; (2) at least one histidine residue; and (3) at least 6% lysine residues.

Abstract: The present invention relates to influenza vaccine formulations and vaccination regimes for immunising against influenza disease. In particular the invention relates to vaccine formulations comprising an oil-in-water emulsion adjuvant and optionally 3D-MPL, their use in medicine, in particular their use in augmenting immune responses to influenza antigens, and to methods of preparation, wherein the oil in water emulsion comprises a sterol, a metabolisable oil and an emulsifying agent.

Abstract: Improved forms of vaccines which comprise proteosomes and protein antigens are described. Vaccines which contain influenza HA as the antigen are used for illustration as to demonstrate efficacy. Improvements in the preparation of the vaccines themselves and the proteosome component are also included.

Abstract: To improve the stability of vaccines comprising aluminum salt(s), the invention uses the amino acid histidine. This can improve pH stability and adjuvant adsorption and can reduce antigen hydrolysis. Histidine is preferably present during adsorption to the aluminum salt(s). The antigen in the vaccine may be a protein or a saccharide and is preferably from N. meningitidis.

Abstract: The present invention encompasses influenza vaccines, in particular canine influenza vaccines. The vaccine may be a recombinant poxvirus vaccine or an inactivated vaccine. The invention also encompasses recombinant poxvirus vectors encoding and expressing influenza antigens, epitopes or immunogens which can be used to protect animals, in particular dogs, against influenza.

Abstract: The present invention relates methods of generating infectious negative-strand virus in host cells by an entirely vector-based system without the aid of a helper virus. In particular, the present invention relates methods of generating infectious recombinant negative-strand RNA viruses intracellularly in the absence of helper virus from expression vectors comprising cDNAs encoding the viral proteins necessary to form ribonucleoprotein complexes (RNPs) and expression vectors comprising cDNA for genomic viral RNA(s) (vRNAs) or the corresponding cRNA(s). The present invention also relates to methods of generating infectious recombinant negative-strand RNA viruses which have mutations in viral genes and/or which express, package and/or present peptides or polypeptides encoded by heterologous nucleic acid sequences.

Abstract: Embodiments of the invention disclosed herein relate to methods and compositions for bypassing the involvement of CD4+ cells when generating antibody and MHC class I-restricted immune responses, controlling the nature and magnitude of the response, and promoting effective immunologic intervention in viral pathogenesis. More specifically, embodiments relate to immunogenic compositions for vaccination particularly therapeutic vaccination, against HIV and other microbial pathogens that impact functioning of the immune system, their nature, and the order, timing, and route of administration by which they are effectively used.

Abstract: Adjuvant compositions comprising an effective amount IL-12 and QS-21 are disclosed. Immunogenic, vaccine and pharmaceutical compositions comprising a mixture of antigen and an adjuvant composition comprising an effective amount of IL-12 and QS-21 are also disclosed. These compositions elicit functional cell-mediated and humoral immune responses against at least one antigen. Methods of using the disclosed compositions are also disclosed.

Abstract: The invention provides methods to detect molecular recognition events. The invention also provides methods to detect the presence of or identify a target species based on its interaction with one or more probe species. The methods of the invention are based on amplification of the signal due to each molecular recognition event. The amplification is achieved through photopolymerization, with the polymer formed being associated with the molecular recognition event. In an embodiment, a fluorescent polymer, a magnetic polymer, a radioactive polymer or an electrically conducting polymer can form the basis of detection and amplification. In another embodiment, a polymer gel swollen with a fluorescent solution, a magnetic solution, a radioactive solution or an electrically conducting solution can form the basis of detection and amplification. In another embodiment, sufficient polymer forms to be detectable by visual inspection.

Abstract: The cold-adapted master strain A/Ann Arbor/6/60 7PI (H2N2) and progenitor wild type E2(3) viral strains have been deposited and their genomic sequences identified. Seven nucleotide differences were found between the sequences identified herein and the previously published sequences for cold-adapted A/Ann Arbor/6/60 genes. The cold-adapted live influenza virus of the present invention can be reassorted with a variety of epidemic wild type influenza viruses and used to produce vaccines to prophylactically and therapeutically treat influenza.

Abstract: To provide a novel preventive and/or therapeutic agent against a virus, disclosed is a preventive and/or therapeutic agent against a viral infection containing geranyl-geranyl acetone as an active ingredient. Also, disclosed are inducers for increasing the activity of an anitiviral factor and for protein kinase containing geranyl-geranyl acetone as an active ingredient. Moreover, a method for preventing and/or treating a viral infection which contains administering a patient a effective amount of an agent containing geranyl-geranyl acetone as an active ingredient.

Abstract: The invention provides a method of inhibiting prophylactically or therapeutically an influenza viral infection in a host. The method comprises instilling into or onto a host a cell producing an antiviral protein, antiviral peptide, or antiviral conjugate comprising at least nine contiguous amino acids of SEQ ID NO: 2, wherein the at least nine contiguous amino acids are nonglycosylated and have antiviral activity, whereupon the influenza viral infection is inhibited.

Abstract: There is provided vaccine compositions for intranasal administration, which compositions comprise one or more antigens and an effective adjuvant amount of a chitosan.

Abstract: An inactivated influenza virus preparation is described which comprises a haemagglutinin antigen stabilized in the absence of thiomersal, or at low levels of thiomersal, wherein the haemagglutinin is detectable by a SRD assay. The influenza virus preparation may comprise a micelle modifying excipient, for example ?-tocopherol or a derivative thereof in a sufficient amount to stabilize the haemagglutinin.

Abstract: The invention relates to conjugates of an antigen coupled to a linear derivative of a ?-stranded antibiotic peptide, which are useful for immunogenic agents to enhance a CTL response. Two groups of preferred peptides are derived from the antibiotics protegrin and tachyplesin.

Abstract: The present invention relates to nanoparticle vaccines comprised of a carrier, particularly polymerized lipids, having multiple copies of an antigen or combinations of different antigens displayed on the carrier. Such antigen-displaying nanoparticles may also display a targeting molecule on its surface in order to direct it to a specific site or cell type to optimize a desired immune response. The present invention also relates to encapsulating an antigen or combinations of different antigens within such nanoparticles, with or without a targeting molecule displayed on its surface. The antigens used in this invention are effective to produce an immune response against a variety of pathological conditions.

Abstract: The invention concerns monoclonal antibodies against the epitope YPYDVPDYA (SEQ ID NO: 1) which is derived from the haemagglutinin of the human influenza virus and are suitable for the detection and isolation of native haemagglutinin of the human influenza virus, of modified haemagglutinin or of haemagglutinin fusion proteins and have an affinity of >108 M?1, in particular of 109 to 1010 M?1.

Abstract: A human synthetic peptide-based influenza vaccine for intranasal administration comprises a mixture of flagella containing at least four epitopes of influenza virus reactive with human cells, each expressed individually in Salmonella flagellin, said influenza virus epitopes being selected from the group consisting of: (i) one B-cell hemagglutinin (HA) epitope; (ii) one T-helper hemagglutinin (HA) or nucleo-protein (NP) epitope that can bind to many HLA molecules; and (iii) at least two cytotoxic lymphocyte (CTL) nucleoprotein (NP) or matrix protein (M) epitopes that are restricted to the most prevalent HLA molecules in different human populations.