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 present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: The present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: The invention provides a vaccine injection, which includes a vaccine and a Traditional Chinese medicinal adjuvant in a mass ratio of 1:0.5-1:10, or a vaccine, a Traditional Chinese medicinal adjuvant and an aluminum adjuvant in a mass ratio of 1:0.5:2.5-1:10:20. The vaccine injection is in the form of powders, and the size of the powders is between 10 and 120 micrometers. The vaccine injection of the present invention is particularly suitable for the needle free injection technology. The invention also provides a preparation method for the vaccine injection.

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 disclosure provides methods for preparing vesicles. In one aspect, the methods involve providing a molten mixture of vesicle-forming lipids and adding the molten mixture of vesicle-forming lipids to an aqueous solution comprising an antigen such that antigen-containing vesicles are formed, wherein in the step of adding the molten mixture of vesicle forming lipids is at a temperature of less than 120° C. In another aspect, the methods involve providing a molten mixture of vesicle-forming lipids and adding an aqueous solution comprising an antigen to the molten mixture of vesicle-forming lipids such that antigen-containing vesicles are formed, wherein the resulting mixture is placed under temperature-controlled conditions of less than 60° C. In yet another aspect, the methods involve providing a solution of vesicle forming lipids and adding the solution of vesicle-forming lipids to an aqueous solution comprising an antigen by injection such that antigen-containing vesicles are formed.

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 attenuated or inactivated virus in combination with a non-ionic surfactant vesicle (NISV).

Abstract: A chimeric viral particle that comprises a RV fusion gene is disclosed. The RV fusion gene comprises a first nucleotide sequence encoding a RV that is devoid of RV E1 protein, and a second nucleotide sequence that linked in translation frame to the first nucleotide sequence and encodes a humoral immunogenic viral protein. The chimeric viral particle is free of RV E1 protein-encoding gene. A virus packaging cell that generates the chimeric viral particle comprising a RV fusion gene and an isolated expression vector comprising a RV fusion gene linked in translation frame to a promoter are also disclosed.

Abstract: The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated form of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.

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 disclosure relates to immunizing agents and devices.

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: The present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: The invention provides, inter alia, immunogenic compositions that comprise (a) a first antigen, (b) at least first and second adjuvants, wherein the first adjuvant comprises microparticles and wherein the second adjuvant comprises an imidazoquinoline compound, and (c) a pharmaceutically acceptable excipient, which compositions elicits an immune response when administered to a vertebrate subject. The invention also provides methods of producing immunogenic compositions and methods for using immunogenic compositions (e.g., for treatment), among other benefits.

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: Adjuvant combinations comprising at least one NKT activator, such as alpha-galactosylceramide (?-Gal-Cer) or iGb3, a CD40 agonist and optionally an antigen are disclosed. The use of these immune adjuvants for treatment of various chronic diseases such as cancers is also provided.

Abstract: The invention provides an immunogenic composition comprising at least one antigen in association with micropar-tides, wherein the microparticles are in the same size range as viruses. In addition the invention also provides vaccine compositions and methods of eliciting immune responses in a subject.

Abstract: The present invention provides a vaccine composition comprising an effective amount of antigen or a nucleic acid encoding antigen, encapsulated in polymeric particles, wherein said polymeric particles comprises nanoparticles, microparticles or combinations thereof, wherein surprisingly the nanoparticle induces cellular response and the microparticle induces humoral response. The invention further provides a method of inducing cellular and/or humoral immune response.

Abstract: Disclosed herein are methods of modulation of the viability of a cell. Further disclosed herein are methods of modulating an immune response. Further disclosed herein are methods of identifying agents capable of modulation of the viability of a cell or an immune response. Further disclosed herein are agents and compositions capable of modulation of the viability of a cell or an immune response.

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: A method of detecting osteoporosis in a mammalian is disclosed herein which includes: a) obtaining a sample of a bone related tissue or cells; and b) measuring the concentration of at least a marker which is either bacteria, bacteria produced factors, or HSPs. The method may further include comparing the concentration with concentrations from the same individual over a period of time or against a standard concentration. The marker may be a bacteria, a chaperone molecule, or a bacteria produced. Also provided herein is a method of treating or preventing osteoporosis caused by a bone disease which includes administering to a mammalian subject a therapeutically effective amount of a formulation which is either an HSP antigenic formulation or a bacterial antigenic formulation. The osteoporosis can be caused by a bone disease induced by bone infectious agents such as viruses, bacteria, fungi, protozoa and parasites.

Abstract: A microprojection array is provided, comprising an approximately planar base and a plurality of microprojections, wherein the array comprises a vaccine and a polymeric material. The array may have multiple layers. The vaccine may be placed in only one layer. In another embodiment of the invention, a method of preventing a disease is provided, comprising insertion into the skin of a patient an array of microprojections comprising a layer which comprises a vaccine for that disease and a polymer.

Abstract: Improved vaccine compositions and methods of use thereof are described that elicit production of antibodies in an individual to the individual's own endogenous cholesteryl ester transfer protein (CETP).

Abstract: The invention provides in part methods of treating cancers of a specific organ or tissue by administering a composition that is antigenically specific for one or more microbes that are pathogenic in the specific organ or tissue in which the cancer is situated. The formulations of the invention thereby facilitate activation of a treatment response to a cancer in a particular tissue or organ. The compositions may for example include killed or attenuated microbial pathogens, and may be administered at sites distant from the cancer, for example the skin. In some embodiments, microbial species of endogenous flora that are known to cause infection in the relevant organ or tissue may be used in the formulation of the antigenic compositions. In alternative embodiments, exogenous microbial pathogens that are known to cause infection in the relevant organ or tissue may be used in the formulation of the antigenic compositions.

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: The present invention relates to the use of erythropoietin (EPO) for enhancing immune responses and for the treatment of lymphoproliferative disorders, excluding multiple myeloma. Accordingly to the invention EPO may be administered with a viral or bacterial vaccine.

Abstract: Methods of producing a pathogen with reduced replicative fitness are disclosed, as are attenuated pathogens produced using the methods. In particular examples, the method includes deoptimizing one or more codons in a coding sequence, thereby reducing the replicative fitness of the pathogen. Methods of using the attenuated pathogens as immunogenic compositions are also disclosed.

Abstract: A prebiotic for enhancement of an immune response, a nutritional composition for enhancement of an immune response; use of a prebiotic in the manufacture of a medicament or nutritional composition for enhancement of an immune response; use of a prebiotic in the manufacture of a medicament or nutritional composition for the prevention or treatment of measles; a method of enhancing an immune response which comprises administering an effective amount of a prebiotic; and a method of prevention or treatment of measles which comprises administering an effective amount of a prebiotic. In preferred embodiments the prebiotic comprises a fructo-oligosaccharide.

Abstract: A new mumps vaccine is presented, comprising a homogeneous pure isolate derived from the Jeryl-Lynn strain of mumps virus. In a preferred embodiment of the invention the vaccine produces higher seroconversion and anitbody titres than know commercial vaccines.

Abstract: A vaccine having a good vaccination effect, which comprises an antigen; a peptide selected from the group consisting of a peptide having the amino acid sequence of SEQ ID NO: 1, a peptide having the amino acid sequence of SEQ ID NO: 2, and a peptide derived from a peptide having the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2; and an immune activator.

Abstract: This invention particularly discloses an improved immunoassay method for the specific detection of anti-rubella IgM antibodies. This method employs rubella antigens comprising rubella E1 and E2 envelope glycoproteins substantially free of capsid protein. Use of this antigen composition reduces or eliminates nonspecific protein-protein interactions leading to false positive results. A sample diluent comprising urea can also be used in the process to further reduce the occurrence of nonspecific protein-protein interactions. A diagnostic kit to aid in the detection of anti-rubella IgM antibodies is also disclosed.

Abstract: This invention particularly discloses an improved immunoassay method for the specific detection of anti-rubella IgM antibodies. This method employs rubella antigens comprising rubella E1 and E2 envelope glycoproteins substantially free of capsid protein. Use of this antigen composition reduces or eliminates nonspecific protein-protein interactions leading to false positive results. A sample diluent comprising urea can also be used in the process to further reduce the occurrence of nonspecific protein-protein interactions. A diagnostic kit to aid in the detection of anti-rubella IgM antibodies is also disclosed.

Abstract: A biologically-active material comprising a live virus or mycoplasma is preserved by a method of desiccation, without lyophilisation, in a matrix of glassy trehalose having a residual moisture content of not greater than 2%. The method comprises two vacuum drying stages. In a cycle time much shorter than a typical freeze drying process a virus or mycoplasma can be preserved to provide a material that can be rehydrated to give a vaccine having potency.

Abstract: Highly infectious rubella virus cDNA clones derived from infectious cDNA clone having a low specific infectivity and methods of obtaining highly infectious rubella virus cDNA clones. Togavirus expression vectors of improved stability for the expression of live, attenuated togavirus and a foreign gene, based on the nucleic acid sequence of an infectious rubella virus clone and contain a togavirus non-structural protein open reading frame; an expression element for expression of a foreign gene; a foreign gene or a multiple cloning site for insertion of a foreign gene; an expression element for the expression of the live, attenuated togavirus; and a togavirus structural protein open reading frame. The expression element is either a subgenomic promoter or an internal ribosome entry site (IRES). Administration of the vector as an immunization agents is useful for the induction of immuity against the togavirus, the foreign gene, or both.

Abstract: Isolated nucleic acid molecules are disclosed, comprising an alphavirus nonstructural protein gene which, when operably incorporated into a recombinant alphavirus particle, eukaryotic layered vector initiation system, or RNA vector replicon, has a reduced level of vector-specific RNA synthesis, as compared to wild-type, and the same or greater level of proteins encoded by RNA transcribed from the viral junction region promoter, as compared to a wild-type recombinant alphavirus particle. Also disclosed are RNA vector replicons, alphavirus vector constructs, and eukaryotic layered vector initiation systems which contain the above-identified nucleic acid molecules.

Abstract: Compositions are provided for improving the stability of live virus vaccines containing, e.g., live varicella zoster, measles, mumps, and rubella viruses. Such improved stabilizers are aqueous solutions containing recombinant human serum albumin (rHA) as a component at from 1-100 g/l. Live virus vaccines as well as methods of preparing live virus vaccines containing the stabilizers are also provided.

Abstract: Synthetic peptides have an amino acids sequence corresponding to at least one antigenic determinant of at least one protein, usually a structural protein, particularly the E1, E2 or C proteins, of rubella virus (RV), are used as is, in hybrid or chimeric tandem T-B form, in lipidated form, linked to a carrier molecule and/or polymerized to form molecular aggregates, in vaccines against rubella. Analogs of peptides which are human T-cell determinants are used to treat rubella-associated autoimmune disorders.