Abstract: A method of treating a patient with a disease wherein the patient contains diseased cells which cells contain antigens for identification and which cells are capable of presenting at least part of said antigen on their surface by an HLA class I (or equivalent) molecule, the method comprising administering to the patient a therapeutically effective amount of either antigen presenting cells which have been gene delivered with the interleukin 12 (IL-12) gene plus a relevant antigen. In a related set of claims said method refers to the administration to a patient of therapeutic levels of cytotoxic T lymphocytes (CTL) which recognize at least part of said antigen when presented by an HLA class I (or equivalent) molecule on the surface of a cell and which these CTL were stimulated by the antigen presenting cells, mentioned in the first section, which have been gene delivered with the interleukin 12 (IL-12) gene plus a relevant antigen.

Abstract: This invention provides methods and compositions to preserve bioactive materials, such as viruses, bacteria, cells, or liposomes, in freeze dried particles suitable for pulmonary administration. Methods provide spray freeze drying of formulations to form stable freeze dried particles.

Abstract: A Chromatography medium having the properties of high virus adsorption and high fluidity, and a method for producing a virus vaccine using these are provided. The Chromatography medium is formed by binding a sulfated polysaccharide to porous particles having an exclusion limit molecular weight of 6000 Da or less when pure water is used as mobile phase and standard polyethylene glycol is used and an average particle size in the range of 30-200 ?m.

Abstract: The present invention encompasses methods of producing influenza B viruses in cell culture. The influenza B viruses may have desirable characteristics, such as enhanced replication in eggs and may be used, for example, in vaccines and in methods of treatment to protect against influenza B virus infection.

Abstract: The present invention provides an influenza B virus M gene with a modification of at least one nucleotide proximate to the N-terminus of the M gene, more specifically at any one of nucleotide positions 265 to 294 of the M gene as well as an influenza B virus comprising said modified M gene. Further, its use for the preparation of a vaccine and methods for preparing said modified influenza virus are disclosed.

Abstract: The present invention provides an adjuvant for cancer antigen peptide vaccines and virus antigen peptides, containing a pertussis vaccine as a primary ingredient. The present invention also provides a therapeutic agent for a cancer or viral infectious disease, and a prophylactic agent for metastasis or recurrence of cancer or onset of virus-induced tumor, containing a cancer antigen peptide or virus antigen peptide and a pertussis vaccine. A pertussis vaccine that can be suitably used is a whole cell body pertussis vaccine. The agents of the present invention can be safely administered in a plurality of doses.

Abstract: The present invention provides an MHC class II antigen presentation enhancing hybrid polypeptide. The hybrid has an N-terminus comprising the mammalian Ii-key peptide LRMKLPKPPKPVSKMR (SEQ ID NO: 1) and modifications thereof which retain antigen presentation enhancing activity, a C-terminus comprising an antigenic epitope in the form of a polypeptide or peptidomimetic structure which binds to the antigenic peptide binding site of an MHC class II molecule, and an intervening chemical structure covalently linking the N-terminal and C-terminal components. In a particular embodiment, the hybrid peptides of the present invention comprise influenza MHC class II epitopes identified herein as being effective in generating an immune response and provide immunity to the individual.

Abstract: The invention provides compositions and methods for detecting the presence of SARS-coronavirus, for screening anti-SARS coronavirus agents and vaccines, and for reducing infection with plus-strand RNA viruses such as SARS-coronavirus.

Abstract: Polypeptides comprising non-typeable Haemophilus influenzae (NTHi) amino acid sequences. Over 2500 specific NTHi proteins are disclosed. The invention also provides related polypeptides, nucleic acids, antibodies and methods. These can all be used in medicine for treating or preventing disease and/or infection caused by H. influenzae, such as otitis media.

Abstract: A method of preparing a pharmaceutical composition is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles at about atmospheric pressure to produce a powder, wherein said drying is performed in the presence of vibration, internals, mechanical stirring, or a combination thereof. Another method is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles to produce a powder; wherein the atomized formulation comprises droplets having an average mean diameter of between about 35? and about 300?, and/or the powder comprises dried particles having an average mean diameter of between about 35? and about 300?. Compositions made by the above methods, and methods of using the compositions, are also described.

Abstract: This invention provides methods, systems 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. Bioactive materials can be preserved with high initial viability in a freeze-foam process employing low temperature secondary drying.

Abstract: The invention refers an improved vaccine against infections with pathogens, especially viral pathogens, comprising an antigen, a peptide of the formula R1—XZSZN—XZX—R2 and an immunostimulatory deoxynucleic acid containing deoxyinosine and/or deoxyuridine residues.

Abstract: Disclosed is a nucleic acid molecule comprising a first expressible sequence encoding a protein of interest or polypeptide of interest which contains an MHC Class II-presented epitope, or said encoded protein or peptide. In addition, the nucleic acid molecule comprises a second expressible nucleic acid sequence encoding an antigen presentation enhancing hybrid polypeptide, or said encoded protein or peptide.

Abstract: An aspect of the present invention is related to nucleic acid constructs capable of expressing a polypeptide that elicits an immune response in a mammal against more than one subtype of dengue virus, and methods of use thereof. Additionally, there are DNA plasmid vaccines capable of generating in a mammal an immune response against a plurality of dengue virus subtypes, comprising a DNA plasmid and a pharmaceutically acceptable excipient, and methods of use thereof. The DNA plasmid is capable of expressing a consensus dengue antigen in a cell of the mammal in a quantity effective to elicit an immune response in the mammal.

Abstract: A method for eliciting or inducing a protective immune response in a subject against a pandemic subtype of influenza virus comprises administering to the subject a composition comprising (i) at least one immunogen of an endemic influenza subtype, and (ii) an immunogen-free immunostimulating complex as adjuvant.

Abstract: The present invention relates, in general, to a screening method for identifying novel viral proteins with interferon antagonizing function using a transfection-based assay, and the use of such proteins in isolating various types of attenuated viruses for the development of vaccine and pharmaceutical formulations. The invention also relates to the use of viral interferon antagonists in screening assays to identify potential anti-viral agents. The invention further relates to protocols utilizing interferon antagonists, e.g., NS1, to enhance gene therapy or DNA vaccination based on their ability to increase gene expression.

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

Abstract: Disclosed herein are sterile-filtered lyophilized nanoparticle compositions which contain at least one biodegradable polymer, at least one surfactant, at least one cryoprotective agent and at least one antigen. Also disclosed are methods of making and using such compositions and kits supplying such compositions.

Abstract: The present invention provides methods of vaccination as well as pharmaceutical combinations and kits for enhancing vaccine effectiveness, including for immunodeficient or immunecompromised patients, including non-responders and low-responders to vaccination. As disclosed herein, the invention relates to administering a vaccine and a regimen of thymosin alpha peptide so as to provide higher antibody titers, speed the development of such antibody titers, and/or to provide for a longer duration of such antibody titers, thereby providing a greater protective effect. In another aspect, the invention allows for reducing a vaccine dose, such as an influenza vaccine dose, by administration of a thymosin peptide regimen.

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 instant invention provides methods for determining, predicting and characterizing the genetic variability, emergence and expansion 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 influenza vaccine formulations and accelerating primary vaccination regimes for immunising against influenza disease, their use in medicine, in particular their use in promoting effective immune responses to various antigens, and to methods of preparation. In particular, the invention relates to two-doses accelerated pandemic or seasonal pandemic primary immunisation regimes with influenza immunogenic compositions comprising an influenza virus or antigenic preparation thereof in combination with an oil-in-water emulsion adjuvant, and to accelerated immunisation regimes.

Abstract: Disclosed herein is a double stranded siRNA molecule that inhibits production of a respiratory virus, wherein each strand of said siRNA molecule is about 15 to about 50 nucleotides, and wherein one strand of said siRNA molecule comprises a nucleic acid sequence identical to a conserved site, or a variant thereof, within the nucleic acid sequence of the respiratory virus, and uses thereof.

Abstract: The present invention features immunogenic compositions comprising codon modified genes that encode viral proteins and/or glycoproteins or fragments. The immunogenic compositions of the invention are useful in various methods of treatment, such as preventing or treating viral infection. Also provided in the present invention are kits and instructions for use.

Abstract: This invention provides pharmaceutical compositions, such as vaccines, and methods of making and using such compositions.

Abstract: A method to prepare viruses with a mutant membrane protein gene, and viruses obtained by the method, are provided.

Abstract: The present invention relates to a pharmaceutical composition containing an mRNA that is stabilised by sequence modifications in the translated region and is optimised for the translation. The pharmaceutical composition according to the invention is particularly suitable as an inoculating agent as well as a therapeutic agent for tissue regeneration. In addition a process is described for determining sequence modifications that serve for the stabilisation and translation optimisation of mRNA.

Abstract: The invention provides, inter alia, immunogenic compositions comprising a first antigen, at least two adjuvants, wherein a first adjuvant comprises a polymer derived from poly(lactides) and/or poly(lactide-co-glycolides), and wherein a second adjuvant comprises an imidazoquinoline, wherein said first antigen is encapsulated within, adsorbed or conjugated to, co-lyophilized or mixed with said first adjuvant, and a pharmaceutically acceptable excipient, wherein said composition elicits a cellular immune response when administered to a vertebrate subject. The invention also provides methods of producing immunogenic compositions, methods for producing a cytotoxic-T lymphocyte (CTL) response in a vertebrate subject, and methods of immunization.

Abstract: The present invention provides a method for purification of a virus or virus antigen comprising providing a virus preparation and centrifugation of said virus preparation in a gradient of a sugar established by the addition of two or more buffered sugar layers of different concentration. The method leads to higher yields and reduces unwanted aggregation of the virus or virus antigen by increasing the volume of the peak pool.

Abstract: The present invention is directed to enhancing the immune response of a human in need of protection against IV infection by administering in vivo, into a tissue of the human, at least one polynucleotide comprising one or more regions of nucleic acid encoding an IV protein or a fragment, a variant, or a derivative thereof. The present invention is further directed to enhancing the immune response of a human in need of protection against IV infection by administering, in vivo, into a tissue of the human, at least one IV protein or a fragment, a variant, or derivative thereof. The IV protein can be, for example, in purified form or can be an inactivated IV, such as those present in inactivated IV vaccines. The polynucleotide is incorporated into the cells of the human in vivo, and an immunologically effective amount of an immunogenic epitope of an IV, or a fragment, variant, or derivative thereof is produced in vivo.

Abstract: The present invention relates to methods and compositions for augmenting an immunogenicity of an antigen in a mammal, comprising administering said antigen together with an adjuvant composition that includes a synthetic glycolipid compound of Formula I, as described herein. According to the present invention, the use of a compound of Formula I as an adjuvant is attributed at least in part to the enhancement and/or extension of antigen-specific Th1-type responses, in particular, CD8+ T cell responses. The methods and compositions of the present invention can be useful for prophylaxis and treatment of various infectious and neoplastic diseases.

Abstract: The invention provided herein relates to vaccines that can be tailored to achieve a desired immune response. Some compositions provided herein are used for preferentially eliciting a humoral immune response while other compositions are useful for preferentially eliciting a cell-mediated response. Combinations of vaccine compositions are also useful for eliciting both types of responses and/or for modulating the type of immune response elicited. The invention also provides methods for eliciting an immune response in an individual by administering the compositions disclosed herein. These immune responses are useful for protecting an individual from various types of diseases, infections, and undesirable conditions.

Abstract: The present invention provides an immunogenic influenza composition in a dose volume suitable for human use, comprising an influenza virus antigen or antigenic preparation thereof and an adjuvant composition comprising an oil-in-water emulsion, wherein said oil-in-water emulsion comprises a metabolisable oil at a level of below 11 mg and an emulsifying agent at a level of below 5 mg and optionally a tocol or a sterol at a level of below 12 mg. Suitably the amount of influenza antigen per strain per dose is 15 ?g HA or a low amount such as less than 15 ?g HA.

Abstract: The present invention relates, in general, to materials and methods for production of an improved vaccine against influenza virus, wherein the vaccine comprises a reassortant virus having a hemagglutinin gene and a neuraminidase gene from the same influenza A virus subtype or influenza B strain of virus and internal genes from a different influenza A virus subtype or influenza B strain of virus. In one aspect, the HA and NA genes and the internal genes are from a highly pathogenic H5N1 strain of influenza A.

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: A method for identifying a motif or a combination of motifs having a Boolean state of predetermined mutations in a set of sequences including a) aligning a set of sequences of ordered motifs represented by a single-character code, b) comparing a reference sequence with the set of sequences aligned in step (a), c) identifying motifs not having mutated simultaneously or motifs having mutated simultaneously at least once on at least one sequence of the set and not having mutated on another sequence of the set.

Abstract: An influenza vaccine that lacks at least three of a mercurial preservative; an antibiotic; formaldehyde; and egg-derived materials. In some embodiments, the vaccine includes none of these four components.

Abstract: Peptides of influenza virus hemagglutinin protein and Plasmodium falciparum malaria antigen, antibodies specific for the peptides, influenza vaccines, malaria vaccines and methods of stimulating the immune response of a subject to produce antibodies to influenza virus or malaria are disclosed. Also disclosed are methods for formulating vaccines for influenza virus.

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: Methods for reducing infectivity by providing an enveloped virus neutralizing compound (EVNC) are provided. Methods of preparing a vaccine, vaccine formulations, and methods of immunizing a subject a further provided. Methods of disinfecting a surface are still further provided. In some embodiments, compositions comprising an isolated and purified bioactive EVNC agent are provided.

Abstract: Virus-like particles (VLPs) of mammalian-hosted viruses, such as SARS-CoV and influenza viruses, have been recombinantly produced from Vero cells. The VLPs closely emulate the exterior of authentic virus particles and are highly immunogenic. They can elicit not only humoral but also cellular immune responses in a mammal. Compositions and methods related to the VLPs are also described.

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

Abstract: A process for the purification of influenza virus or derivative thereof comprising the steps of: providing a source having influenza virus or derivative thereof; optionally subjecting the source to a prepurification step; followed by at least one chromatographic step on chromatographic materials selected from the group consisting of porous particles having mean pore sizes of at least 20 nm, perfusion particles, gel-in-a-shell particles, tentacle like particles, membrane adsorbers, and monoliths; collecting eluting influenza virus or derivatives thereof containing fractions with the proviso that sulfuric ester of cellulose or cross-linked polysaccharides are excluded.

Abstract: The present invention relates, in general, to attenuated negative-strand RNA viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. The invention also relates to the development and use of IFN-deficient systems for selection of such attenuated viruses. In particular, the invention relates to attenuated influenza viruses having modifications to the NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. The mutant viruses replicate in vivo but demonstrate reduced pathogenicity, and therefore are well suited for live virus vaccines, and pharmaceutical formulations.

Abstract: Patients receive a mucosal influenza vaccine and then receive a parenteral influenza vaccine, in that order, typically during different visits to a vaccination center.

Abstract: The present invention provides multiple antigenic agents compositions and the use thereof to prevent or treat viral infections.

Abstract: The present invention features methods and compositions related to chitosan antigen depots, and chitosan cytokine depots, and the use of depot compositions in treating and preventing diseases.

Abstract: The presently disclosed invention is broadly directed to therapeutic micro- and/or nanoparticles designed to target an immune cell with an active agent. More particularly, the particles have a predetermined geometry and a broadest dimension of less than about 10 ?m. The immune cell-targeted micro and/or nanoparticles may additionally comprise a biocompatible polymer.

Abstract: The invention relates to new vaccine compositions for vaccinating birds.

Abstract: The invention provided herein relates to vaccines that can be tailored to achieve a desired immune response. Some compositions provided herein are used for preferentially eliciting a humoral immune response while other compositions are useful for preferentially eliciting a cell-mediated response. Combinations of vaccine compositions are also useful for eliciting both types of responses and/or for modulating the type of immune response elicited. The invention also provides methods for eliciting an immune response in an individual by administering the compositions disclosed herein. These immune responses are useful for protecting an individual from various types of diseases, infections, and undesirable conditions.