Abstract: A method of increasing gene expression by manipulating the circadian clock is described that includes transforming a photosynthetic organism to include an expression control sequence that modulates the expression of a clock gene to increase expression of a target gene. Photosynthetic organism having a modified circadian cycle reflecting this method are also described.

Abstract: The present invention provides adjuvant compositions that are capable of modulating the immune response in a subject, including enhancing or suppressing the immune response. These adjuvant compositions may also be used to enhance or suppress the immunogenicity of antigens by enhancing or suppressing antigen-presentation activity, enhancing or suppressing innate immune responses through activation or suppression of, e.g., natural killer cells, and/or direct activation of subsets of B and/or T cells. Also provided are methods of making the adjuvant compositions as well as methods of using the adjuvant compositions. In certain embodiments, the compositions comprise combinations of the following: a pharmaceutically acceptable carrier, a flavonoid, a tannin and a vitamin. The compositions may further comprise an antigen.

Abstract: The present invention relates in one aspect to a conjugate of a mucopolysaccharide or mucopolysaccharidic fraction and a cellular wall fragment of a bacterium belonging to the Corynebacterium genus, and in particular to the Corynebacterium granulosum species, also named P40. The conjugate of the invention is applied to medicine, in particular for topical treatment of infections, dermatological affections, such as psoriasis, acne, allergic reactions, such as rashes and eczema, and in vaginal mucosae affections.

Abstract: The present invention relates to a fermentation medium for cultivating Corynebacterium diphtheriae. The present invention also relates to the use of the fermentation medium in processes for obtaining diphtheria toxin from the Corynebacterium diphtheriae bacteria being cultivated and the preparation of vaccines using the diphtheria toxin obtained in the processes. The present invention further relates to a purification and detoxification processes specifically adapted for preparing a diphtheria toxoid for inclusion into a vaccine.

Abstract: A vaccine adjuvant composition comprising: a lipid selected from the group consisting of: dipalmitoyl phosphatidicholine (DPPC), dipalmitoyl phosphatidylglycerol (DPPG), dioleoyl phosphatidylcholine (DOPC), and cholesterol and containing a positively or negatively charged lipid with associated/entrapped protein 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 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: Process for the production of cadaverine by constructing a recombinant microorganism which has a deregulated lysine decarboxylase gene and at least one deregulated gene selected from the group (i) which consists of aspartokinase, aspartatesemialdehyde dehydrogenase, dihydrodipicolinate synthase, dihydrodipicolinate reductase, tetrahydrodipicolinate succinylase, succinyl-amino-ketopimelate transaminase, succinyl-diamino-pimelate desuccinylase, diaminopimelate epimerase, diaminopimelate dehydrogenase, arginyl-tRNA synthetase, diaminopimelate decarboxylase, pyruvate carboxylase, phosphoenolpyruvate carboxylase, glucose-6-phosphate dehydrogenase, transketolase, transaldolase, 6-phosphogluconolactonase, fructose 1,6-biphosphatase, homoserine dehydrogenase, phophoenolpyruvate carboxykinase, succinyl-CoA synthetase, methylmalonyl-CoA mutase, provided that if aspartokinase is deregulated as gene (i) at least a second gene (i) other than aspartokinase has to be deregulated, and cultivating said microorganism.

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 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: The invention provides a diphtheria, tetanus and pertussis vaccine comprising a low dose of each of diphtheria toxoid (D), tetanus toxoid (T), pertussis toxin (PT), filamentous haemagglutinin (FHA) and pertactin (69K). The vaccine maintains an ability to prevent pertussis while showing exceptionally low reactogenicity. Combination vaccines comprising additional antigens are also provided.

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 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: Rhodococcus equi (R.equi) has been determined to have a major adhesion factor encoded by a rpl pathogenicity island which enables host colonisation, wherein the rpl pathogenicity islandis absent from non-pathogenic Rhodococcus species. Further, the proteins (Rpl) encoded by the rpl pathogenicity island have been determined to be major immunodominant antigens. There is provided a novel diagnostic marker and vaccine candidate for R. equi in horses and other susceptible species.

Abstract: Immunogenic compositions containing phospholipid adjuvants, including microparticle and emulsion compositions. According to one aspect of the invention, an immunogenic microparticle composition is provided comprising: water; a polymer microparticle; an antigen adsorbed to the microparticle; and a phospholipid compound, e.g., a synthetic phospholipid compound comprising: (i) one or more phosphoryl groups independently selected from a phosphato group and a phosphodiester group; (ii) a plurality of linear alkane groups. According to another aspect of the invention an immunogenic emulsion composition is provided that comprises: water; a metabolizable oil; an emulsifying agent; an antigen; and a phospholipid compound, e.g., a synthetic phospholipid compound like that above. The emulsion composition is an oil-in-water emulsion having oil and aqueous phases, in which the oil phase is in the form of oil droplets, substantially all of which are less than 1 micron in diameter.

Abstract: The invention relates to the use of Campylobacter jejuni gene product jlpA and immunogenic fragments of jlpA as a component of a pharmaceutical formulation capable of eliciting an anti-Campylobacter jejuni immune response. The invention also relates to a method of inducing an anti-Campylobacter immune response by the administration of C. jejuni jlpA gene products or immunogenic fragments of such gene product to a subject.

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: A method is provided for producing hIGF-I with high purity and yield. This is a method for producing human insulin-like growth factor I, having a step of removing modified human insulin-like growth factor I from the human insulin-like growth factor I, the step including: (A) a step of adjusting the pH of a culture liquid of a human insulin-like growth factor I producing bacteria to 8 or more after completion of culture; (B) a step of letting the culture liquid obtained in step (A) stand; and (C) a step of removing the producing bacteria from the culture liquid obtained in step (B).

Abstract: An object of the present invention is to provide a peptide vaccine for preventing and/or treating diseases caused by amyloid ?-peptide, such as Alzheimer's disease. The present invention solves the above object by providing a peptide vaccine constructed by inserting a peptide having an amino acid sequence of a cell attachment motif of a cell adhesive molecule to a peptide which consists of a peptide having an amino acid sequence of multiagretope type T-cell epitope, which has been generated immunological memory, or a peptide including the same; an linker peptide; and a peptide having an amino acid sequence of a B cell epitope which is a specific region of amyloid ?-peptide or a peptide including the same.

Abstract: The present invention relates to the field of vaccines, and in particular vaccines comprising antigens of low isoelectric point at pH 7.0, in particular the capsular polysaccharide or oligosaccharide of H. influenzae B (PRP). Immunogenic compositions and methods of making such compositions are presented in which the PRP is surprisingly protected from immune interference by adding a polyanionic polymer (such as PLG-poly-L-glutamic acid) to the composition.

Abstract: The invention relates to a preservation composition, a formulation comprising a preservation mixture of glutamate, a saccharide, and a polymer. Said preservation mixture is advantageously used for the preservation of a biological compound.

Abstract: Improved (safer and more effective) methods of therapy using TNF-R agonists, e.g., CD40 agonists are provided. These methods provide for the addition of an amount of a type 1 interferon and/or a TLR agonist that is effective to prevent or reduce the toxicity (liver toxicity) that may otherwise result in some patients of the TNF-R agonist is used as a monotherapy (without the type 1 interferon and/r TLR agonist).

Abstract: Liquid pharmaceutical compositions for administration to a mucosal surface, including a therapeutic agent and a pectin with a low degree of esterification are described. Such compositions gel, or can be adapted to gel, at the site of application in the absence of an extraneous source of divalent metal ions.

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: The invention provides a chimeric peptide or mixture of chimeric peptides that can be formulated as an immunizing composition and used in a method for immunization of a mammal against an internal peptide cleavage product derived from a precursor or mature protein, for which the peptide cleavage product and the precursor or mature protein are self molecules. The chimeric peptide or peptides have an end-specific B cell epitope from a naturally-occurring internal peptide cleavage product of a precursor or mature protein, as a free N- or C-terminus, fused with or without spacer residues to a T helper cell epitope derived from a living source different from that of the internal peptide cleavage product.

Abstract: The present invention provides a Withania somnifera fraction rich in withanolides and a vaccine comprising a “Withania somnifera fraction” as an adjuvant.

Abstract: This application relates to compositions comprising components prepared from Gram positive bacteria such as Gram positive facultative intracellular bacteria for treatment of disorders comprising an immune dysregulation in humans and animals.

Abstract: The present invention relates to an adjuvant derived from human lymphocytes. The adjuvant can be used in combination with traditional vaccines or cancer immunotherapy, to enhance the response of the patient's immune system to the vaccine or other immunotherapeutic agent. The adjuvant is derived from the supernatant collected from cultured activated lymphocytes.

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 object is to provide a liposome by which a bacterial cell component insoluble in water and an organic solvent (e.g., BCG-CW) can be pharmaceutically prepared in a form applicable to a living body (i.e., a form in which the bacterial cell component can be dispersed in an aqueous solvent and has a controlled size) without using any surfactant. Disclosed is a liposome having a lipid membrane containing a bacterial cell component insoluble in water and an organic solvent (e.g., BCG-CW).

Abstract: The present invention relates to the field of prevention and treatment of tumors and gastrointestinal disorders. The present invention relates to the prevention and treatment of Core-1-positive carcinomas. The invention relates to coreotics and a method of producing the same and to a method of prevention and treatment of core-1 positive disorders using the same. The invention relates to microorganisms or fractions thereof capable of activating cellular immunity against carbohydrates.

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 immunogenic compositions comprising a multilayer film comprising two or more layers of polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes. A first layer polyelectrolyte comprises an antigenic polypeptide comprising one or more surface adsorption regions covalently linked to one or more antigenic determinant regions, wherein the antigenic polypeptide and the one or more surface adsorption regions have the same polarity. The immunogenic compositions may be employed in methods of eliciting an immune response in a vertebrate organism.

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 newly identified serum resistance factor of gram positive bacteria can be used to treat or prevent bacterial infection.

Abstract: The present invention describes derivatized polysaccharide-protein conjugates, a composition comprising one or more of such derivatized polysaccharide-protein conjugates and methods of immunizing human patients with the same. The derivatized polysaccharide-protein conjugates are purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y, derivatized chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains.

Abstract: Immunogenic compositions are described herein which comprise microparticles that further comprise a biodegradable polymer. The microparticle compositions also comprise a cationic polysaccharide and an immunological species selected from an antigen, an immunological adjuvant and a combination thereof. Also described are methods of making such compositions and methods of administering such compositions. Methods of modulating the release rate of immunological species from microparticles are also described. These methods comprise varying the ratio of the cationic polysaccharide relative to the biodegradable polymer within the microparticles.

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: Vitreous compositions of an antigen and adjuvant, and methods for making the compositions are disclosed. Also disclosed are pharmaceutically acceptable formulations of the vitreous compositions, reconstituted liquid formulations of the vitreous compositions, vaccine compositions, and kits containing the vitreous compositions. Also disclosed are devices for administering the vitreous compositions to mammals and methods for eliciting an immune response in mammals by administering the compositions.

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: 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 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: Mucosal DTPa vaccines, especially intranasal vaccines, comprising (a) a diphtheria antigen, a tetanus antigen and an acellular pertussis antigen, and (b) a detoxified mutant of cholera toxin (CT) or E. coli heat labile toxin (LT). Component (b) acts as a mucosal adjuvant. The acellular pertussis antigen preferably comprises pertussis holotoxin (PT) and filamentous haemagglutinin (FHA) and, optionally, pertactin. The mucosally-delivered combined DTPa formulation is capable of generating a level of protection against B. pertussis infection equivalent to that observed by alum-adjuvanted parenteral administration.

Abstract: Mycobacterium tuberculosis protein having a molecular weight of 28 779 Da, and hybrid proteins containing at least portions of its sequence. These proteins may in particular be used in vaccines or for the detection of specific tuberculosis antibodies.

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 vaccine compositions comprising iron phosphate as adjuvant. This iron phosphate is in the form of particles, the size of which is between 0.01 ?m and 300 ?m; it can be obtained by mixing a solution of iron salt and of phosphate salt.

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.