Abstract: The invention relates to methods for the preparation of a pharmaceutical-vesicle formulation comprising steps of: preparing and processing vesicle components and a pharmaceutical agent to entrap the pharmaceutical agent in the vesicle and form a pharmaceutical-vesicle formulation, wherein the pharmaceutical-vesicle formulation is reconstituted in a known quantity of the pharmaceutical agent dissolved in a pharmaceutically-acceptable carrier to provide a biphasic pharmaceutical-vesicle formulation. The invention also relates to the associated pharmaceutical-vesicle formulations, pharmaceutical kits and uses as a medicament, in particular for the prevention or treatment of infection by bacteria such as Burkholderia pseudomallei and Francisella tularensis, and viruses such as Venezuelan Equine Encephalitis Virus (VEEV).

Abstract: The present disclosure relates to a composition comprising PIC for treatment of cancer. More particularly, the present disclosure discloses a composition for treatment of cancer comprising polyinosinic-polycytidylic acid, an antibiotic or polyamine compound, a positive ion, and optionally a virus, and the use thereof in manufacture of a medicament for treatment of cancer. No figure for publication.

Abstract: This application pertains to methods of isolating virus particles and producing virus vaccine composition comprising subject a biological sample to an anion exchange chromatography and a hydroxyapatite chromatography. The application also pertains to rabies virus vaccine compositions and methods of assessing suitability of a virus vaccine composition or releasing a commercial batch of virus vaccine composition for clinical use.

Abstract: This application pertains to methods of isolating virus particles and producing virus vaccine composition comprising subject a biological sample to an anion exchange chromatography and a hydroxyapatite chromatography. The application also pertains to rabies virus vaccine compositions and methods of assessing suitability of a virus vaccine composition or releasing a commercial batch of virus vaccine composition for clinical use.

Abstract: The present invention relates to adjuvanted recombinant anti-rabies vaccines and the oral administration of such vaccines to raccoons and other wildlife. Advantageously, the anti-rabies vaccine may comprise a recombinant vaccinia virus containing a rabies glycoprotein gene. The invention encompasses methods of vaccinating raccoons and other wildlife by administration of an anti-rabies vaccines which may comprise a recombinant vaccinia virus containing a rabies glycoprotein gene, in combination with an adjuvant which increases both vaccine viscosity and efficacy. The invention provides effective oral recombinant vaccines used in oral rabies vaccination (ORV) programs for wildlife, effective at protecting raccoons, gray foxes, coyotes, and other animals.

Abstract: The invention relates to a vaccine composition comprising: a) inactivated whole virus, and b) a stabilizing excipient which comprises: i. a buffer solution, ii. a mixture of essential and nonessential amino acids, iii. a disaccharide, iv. a polyol, v. a chelating agent, vi. urea or a urea derivative, and vii. a nonionic surfactant.

Abstract: The present invention is directed to a pharmaceutical composition including (e.g. for use as an adjuvant) a polymeric carrier cargo complex, comprising as a carrier a polymeric carrier formed by disulfide-crosslinked cationic components; and as a cargo at least one nucleic acid molecule, and at least one antigen that is selected from an antigen from a pathogen associated with infectious disease; an antigen associated with allergy or allergic disease; an antigen associated with autoimmune disease; or an antigen associated with a cancer or tumour disease, or in each case a fragment, variant and/or derivative of said antigen. The pharmaceutical composition allows for efficient induction of an adaptive immune response directed against said antigen. The present invention furthermore provides kits, as well as the use of the pharmaceutical composition or the kit as a vaccine, particularly in the treatment of infectious diseases, allergies, autoimmune diseases and tumour or cancer diseases.

Abstract: The present invention relates to a probiotic cell transformed with a construct suitable to overexpress and display on the surface of the probiotic cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides. Probiotic-derived vesicles displaying this fusion protein as well as methods of inducing an immune response using the probiotic cells or vesicles are also disclosed.

Abstract: The subject of the invention is a method for purifying the rabies virus, comprising a single ion-exchange chromatography step, said step being cation exchange chromatography according to which: a) the supernatant of a culture of cells infected with this virus is brought into contact with a cation exchange chromatography support comprising a polymethacrylate matrix onto which sulfoisobutyl groups have been grafted such that the rabies virus binds to this support, and; b) the virus is eluted from its support.

Abstract: A novel process for the purification of recombinant protein expressed as particle is herewith described. In this purification process, the protein is purified by hydrophobic interaction. The interaction of this protein step resulted in an increase in recovery and purity from 15%-80%. The protein further purified has its application in vaccines and pharmaceuticals.

Abstract: The present invention relates to methods and compositions for use in inducing tumor-specific antibody mediated complement-dependent cytotoxic response in an animal having a tumor comprising administering to said animal a composition comprising a replication competent oncolytic virus wherein administration of the composition induces in the animal production of antibodies that mediate a CDC response specific to said tumor.

Abstract: The efficacy of rabies vaccines can be enhanced by adjuvanting rabies virus immunogens with a mixture of a TLR agonist (preferably a TLR7 agonist) and an insoluble metal salt (preferably an aluminium salt). The TLR agonist is typically adsorbed to the metal salt. The rabies virus immunogen can also be adsorbed to the metal salt.

Abstract: Compositions and methods are provided that enable activation of innate immune responses through RIG-I like receptor signaling. The compositions and methods incorporate synthetic nucleic acid pathogen associated molecular patterns (PAMPs) that comprise elements initially characterized in, and derived from, the hepatitis C virus genome.

Abstract: The present disclosure provides compositions and methods useful for treating viral infections. As described herein, the compositions and methods are based on the development of immunogenic compositions that include an inactivated virus in combination with a non-ionic surfactant vesicle (NISV). In certain embodiments at least a portion of the antigen present in the composition is physically associated with the NISV. In certain embodiments the compositions are lyophilized and subsequently rehydrated after a period of storage. In certain embodiments the rehydrated compositions exhibit greater potency as compared to otherwise equivalent compositions that lack the NISV. In certain embodiments the lyophilized compositions are stored at temperatures in excess of 8° C. prior to rehydration. In certain embodiments the rehydrated compositions exhibit greater potency as compared to otherwise equivalent compositions that lack the NISV and that were also stored at temperatures in excess of 8° C. prior to rehydration.

Abstract: Biopharmaceuticals, such as vaccine agents and probiotics, are encapsulated in carbohydrate-glass particles and embedded in an amorphous polymer substrate to produce polymeric compositions containing ambient-temperature stable biopharmaceuticals for syringeless administration to patients such as via dissolvable films, micro-needle patches and similar medical delivery devices. The amorphous polymer substrate is soluble in both water and volatile organic solvents, yet the carbohydrate-glass particles are insoluble in organic solvents. A method for formulation of the polymeric compositions containing ambient-temperature stable biopharmaceuticals includes combining biopharmaceuticals encapsulated in carbohydrate-glass particles with polymer in organic solvent and evaporating the organic solvent to yield a water soluble polymeric composition containing ambient-temperature stable biopharmaceuticals.

Abstract: The present invention provides a composition comprising or consisting of inulin particles for use in the reduction or inhibition of inflammation, and/or for treating or preventing inflammatory disease, in a subject. Also provided is a pharmaceutically acceptable composition comprising: particles of inulin; and a substance comprising or consisting of one or more pathogen-associated molecular patterns (PAMPs), or an equivalent kit of parts, and methods and uses of the composition and kit for inducing or modulating an immune response in a subject, such as modulating an immune response to an antigen or allergen and/or as a vaccine. Also provided is a single-dose vaccine composition comprising inulin particles, an antigen and, optionally, an antigen-binding carrier material, and methods and uses of the vaccine.

Abstract: Rabies Virus compositions and methods are provided. The full-length sequence of Rabies Virus strain Evelyn-Rokitnicki-Abelseth (ERA) is disclosed. A reverse genetics system for producing recombinant ERA virus and derivatives thereof is provided, along with compositions including ERA and/or ERA derivative strain viruses, nucleic acids and/or proteins. In some instances, the compositions are immunogenic compositions useful for the pre- or post-exposure treatment of Rabies Virus.

Abstract: Provided herein are methods and compositions for stabilization of active agents. The active agents are distributed, mixed or embedded in a silk fibroin matrix, thereby retaining the bioactivity of the active agents upon storage and/or transportation. In some embodiments, the storage-stable vaccine-silk compositions are also provided herein.

Abstract: A method for inducing an immune response by injecting an immunogen into a subject's testis. A composition for intra-testicular injection including an immunogen such as a rabies vaccine and a chemical sterilant formed of zinc gluconate and an amino acid capable of forming an aqueous solution neutralized to a pH from 6.0 to 7.5. When injected intra-testicularly, the immunogen is slowly released reducing or eliminating the need for a “booster” dose, while the chemical sterilant is effective at reducing the dog population.

Abstract: A method of producing a virus like particle (VLP) in a plant is provided. The method comprises introducing a first nucleic acid into the plant, or portion of the plant. The first nucleic acid comprising a first regulatory region active in the plant operatively linked to a nucleotide sequence encoding a native rabies virus structural protein. The nucleotide sequence may further comprise one or more than one amplification element. Optionally, a second nucleic acid might be introduced into the plant, or portion of the plant. The second nucleic acid comprising a second regulatory region active in the plant and operatively linked to a nucleotide sequence encoding a matrix protein, for example but not limited to a rabies matrix protein. The plant or portion of the plant is incubated under conditions that permit the expression of the nucleic acids, thereby producing the VLP.

Abstract: The present invention relates to recombinant raccoon poxvirus vectors that express the rabies virus glycoprotein gene at the hemagglutinin (ha) locus of the poxvirus genome or express the glycoprotein gene of the same or different rabies strains at the thymidine kinase (tk) and the hemagglutinin (ha) loci of the poxvirus genome, and their use as adjuvant-free vaccines. The raccoon poxvirus vector comprises the nucleic acid molecules encoding the glycoprotein of a Challenge Virus Standard rabies strain inserted and expressed at the tk locus of the poxvirus genome and of a Pasteur-Paris rabies strain inserted and expressed at the ha locus of the poxvirus genome. The vaccine may optionally contain a mixture of additional feline and canine antigens for immunization of animals. Also disclosed are methods for inducing an immune response to rabies in a mammal by administering to the mammal an effective immunizing amount of the vaccine of the invention.

Abstract: A vaccination method is provided. The method comprises administering to a mammal a histone deacytelase inhibitor in conjunction with a vaccine that expresses an antigen to which the mammal has a pre-existing immunity.

Abstract: The invention provides for a method of enhancing immunological responses to an antigen in a vaccine formulation, and for a vaccine formulation that provides for an enhanced immunological response to an antigen. In the method and formulation the antigen is administered with an adjuvant which adjuvant comprises a solution of nitrous oxide gas in a pharmaceutically acceptable carrier solvent for the gas and which adjuvant includes at least one fatty acid or ester or other suitable derivative thereof selected from the group consisting of oleic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, arachidonic acid, eicosapentaenoic acid [C20: 5?3], decosahexaenoic acid [C22: 6?3], ricinoleic acid and derivatives thereof selected from the group consisting of the C1 to C6 alkyl esters thereof, the glycerol-polyethylene glycol esters thereof and the reaction product of hydrogenated natural oils composed largely of ricinoleic acid based oils, such as castor oil with ethylene oxide.

Abstract: A first composition comprising a ligand part being able to specifically bind to a target, the target being on a diseased cell of an organism, and an epitope part having a non-self epitope, or encoding a non-self epitope, the non-self epitope not naturally being encoded by the organism, wherein the target is internalized after forming a complex with the composition and the non-self epitope is presented on the cell surface of said diseased cell of an organism after internalization.

Abstract: The present invention provides compositions and methods useful for delivering agents to target cells or tissues, for example nerve cells and other cells in the central nervous system. The compositions and methods are useful for delivering agents across the blood-brain barrier. The present invention also provides methods of using the compositions provided by the present invention to deliver agents, for example therapeutic agents for the treatment of neurologically related disorders.

Abstract: The present invention relates to the design of gene transfer vectors and especially provides lentiviral gene transfer vectors suitable for either a unique administration or for iterative administration in a host, and to their medicinal application (such as vaccination against Immunodeficiency Virus, especially suitable in human hosts). Gene transfer vectors can be either integrative or non-integrative vectors. The invention encompasses prophylactic, therapeutic, symptomatic, and curative treatments of animals, including humans, as well as gene therapy and vaccination in vivo.

Abstract: Disclosed and claimed is a method of non-invasive immunization in an animal and/or a method of inducing a systemic immune response or systemic therapeutic response to a gene product. The skin of the animal is contacted with a non-replicative vector chosen from the group of bacterium, virus, and fungus, wherein the vector comprises and expresses a nucleic acid molecule encoding the gene product, in an amount effective to induce the response.

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

Abstract: The present invention broadly relates to the synergistic attenuation of vesicular stomatitis virus (VSV), More particularly, the invention relates to the identification of combined mutation classes which synergistically attenuate the pathogenicity of VSV vectors in mammals and immunogenic compositions thereof.

Abstract: The invention relates to a vaccine composition comprising: a) inactivated whole virus, and b) a stabilizing excipient which comprises: i. a buffer solution, ii. a mixture of essential and nonessential amino acids, iii. a disaccharide, iv. a polyol, v. a chelating agent, vi. urea or a urea derivative, and vii. a nonionic surfactant.

Abstract: The present invention relates to immunogenic compositions for modulating the immune system, comprising a therapeutically effective quantity of two or more immuno-active antigenic agents with pathogen-associated molecular patterns (PAMPs) and/or danger-associated molecular patterns (DAMPs) and one or more physiologically acceptable carriers, excipients, diluents or solvents. The immunogenic compositions according to the present invention are used for producing medicaments for preventing and/or treating, and for preventing and/or treating infectious diseases, auto-immune diseases, allergic diseases, inflammation, arthritis, inflammatory diseases, transplant rejection, affections caused by vascular disorders, diseases caused by haemorrhagic or ischaemic cardiovascular accidents, ischaemia, heart attack and haemorrhagia leading to tissue destruction, heart, kidney, respiratory or liver insufficiency, cancer, malign and benign tumours and neoplasia.

Abstract: Delivery systems and methods are provided for delivering a biologically active protein to a host animal. The systems and methods provided include obtaining an algal cell transformed by an expression vector, the expression vector comprising a nucleotide sequence coding for the biologically active protein, operably linked to a promoter. In one illustrated embodiment, the biologically active protein is an antigenic epitope and upon administration to the animal the algal cell induces an immune response in the host animal.

Abstract: The present invention provides a new means of restoring the immune system in aging and immunocompromised individuals using an antioxidant nutraceutical. The nutraceutical stimulates the aging immune system through the Nrf2 master gene regulatory pathway. The invention is based in part on the discovery that the Nrf2 has antioxidant and immune restorative activity. The nutraceutical improves function of both the innate and adaptive immune systems.

Abstract: The present invention relates to the generation of replication-competent viruses having therapeutic utility. The replication-competent viruses of the invention can express proteins useful in the treatment of disease.

Abstract: This invention disclosed an anti-HPV drug and its applications in preparing medicines for treatment of HPV (human papilloma virus) infection. This drug was characterized by using human rabies vaccine as its active ingredient and being produced by adding pharmacologically acceptable carriers. This invention also disclosed drug applications in preparing medicines for treatment of HPV infection, i.e. new applications of human rabies vaccines for preparing medicines against HPV infection. The anti-HPV drug described in this invention (i.e. human rabies vaccine) had obvious treatment effects on HPV infection. According to the animal tests and preclinical observation, this drug provided satisfactory and beneficial effects and had the characteristics of safety, effectiveness and nearly no recurrence after treatment; the negative-conversion rate in patients with positive HPV-infection reached 90% after treatment.

Abstract: The invention relates to a vaccine composition comprising: a) inactivated whole virus, and b) a stabilizing excipient which comprises: i. a buffer solution, ii. a mixture of essential and nonessential amino acids, iii. a disaccharide, iv. a polyol, v. a chelating agent, vi. urea or a urea derivative, and vii. a nonionic surfactant.

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: The present invention provides for a novel vaccine formulation comprising plasmid DNA and a lipid adjuvant. The invention also provides for prime-boost vaccination methods wherein two sequential administration of the same plasmid-based DNA vaccine provide companion animals with protection against rabies for at least one year.

Abstract: Described herein are recombinant rabies viruses encoding rabies virus glycoprotein and at least one heterologous glycoprotein from another lyssavirus, such as Mokola virus, Lagos bat virus and/or West Caucasian bat virus. In particular embodiments, the recombinant rabies virus includes two or three heterologous lyssavirus glycoproteins. The disclosed recombinant rabies viruses can be used as pan-lyssavirus vaccines to provide protection against lyssaviruses that cause rabies.

Abstract: The present invention relates to the design of gene transfer vectors and especially provides lentiviral gene transfer vectors suitable for either a unique administration or, for iterative administration in a host, and to their medicinal application (such as vaccination against Immunodeficiency Virus, especially suitable in human hosts). Gene transfer vectors are either integrative or non-integrative (NI) vectors, dependently upon the purpose of their use. The invention relates to the use of gene transfer vectors for unique or for multiple in vivo administration into a host in need thereof. The field of application of the present application concerns in particular animal treatment or treatment of human being (e.g. prophylactic or therapeutic or symptomatic or curative treatment), gene therapy or vaccination in vivo.

Abstract: One aspect of the present disclosure relates to a method for treating a subject with cancer. The method includes administering an oncolytic virus simultaneously, sequentially, or separately in combination with an immunomodulatory agent in an amount effective to suppress both antiviral immunity and angiogenesis associated with the cancer.

Abstract: The invention provides a recombinant rabies viruses comprising three copies of a mutated G gene wherein each G gene encodes a rabies virus glycoprotein having the amino acid 194 mutated to a serine and the amino acid 333 is mutated to a glutamic acid. The recombinant rabies virus is nonpathogenic in immunodeficient mammals and can be used in a vaccine to induce an immune response protect mammals from infection by rabies virus as well as clear a pre-existing rabies virus infection from neural tissues.

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

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

Abstract: Human monoclonal antibodies that specifically bind to rabies virus, antigen binding portions thereof, and methods of making and using such antibodies and antigen binding portions thereof for treating rabies virus in a subject, are provided herein.

Abstract: Methods for protecting the brain and other tissues from virus-associated toxicity are provided. Patients are treated with a first immunizing virus prior to administration of a second, therapeutic cytolytic virus. The immunizing virus is preferably administered peripherally, and initiates an adaptive immune response that is sufficient to reduce or prevent the cytovirulence and inflammation caused by the therapeutic virus. The immunizing virus is administered one or more times, preferably at least twice, before administration of the therapeutic virus. The therapeutic virus can be the same virus as the immunizing virus, or a mutant or variant thereof. Preferably the therapeutic virus is an attenuated virus with reduced virulence compared to the immunizing virus.

Abstract: The present invention is directed to a method of reducing the viability of a tumor cell involving administering a virus that is not a common human pathogen to the tumor cell. Preferably, the virus exhibits differential susceptibility, in that normal cells are not affected by the virus. This differential susceptibility is more pronounced in the presence of interferon. The tumor cell is characterized by having low levels, or no, PKR activity, or as being PKR?/?, STAT1?/? or both PKR?/? and STAT1?/?. The virus is selected from the group consisting of Rhabdovirus and picornavirus, and preferably is vesicular stomatitis virus (VSV) or a derivative thereof.

Abstract: In one aspect, a method of treating cancer in a mammal is provided. The method comprises administering to the mammal an oncolytic vector that expresses a tumour antigen to which the mammal has a pre-existing immunity. In another aspect, a method of boosting immune response in a mammal having a pre-existing immunity to an antigen is provided comprising intravenous administration to the mammal of a B-cell infecting vector that expresses the antigen.

Abstract: Disclosed are dosage forms and related methods, that include a first population of synthetic nanocarriers that have one or more first antigens coupled to them, one or more second antigens that are not coupled to the synthetic nanocarriers, and a pharmaceutically acceptable excipient.

Abstract: An attenuated rabies virus for use as a vaccine. The attenuated rabies virus expresses an immune factor that enhances immune response upon administration of the vaccine.