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: Immunogenic compositions and methods for eliciting an immune response against B. anthracis and other bacilli are provided that include immunogenic conjugates of a poly-?-glutamic acid (?PGA) polypeptide of B. anthracis, or of another Bacillus that expresses a ?PGA polypeptide. The ?PGA conjugates elicit an effective immune response against B. anthracis, or against another Bacillus, in mammalian hosts to which the conjugates are administered.

Abstract: Disclosed are compositions and methods for treating a subject infected with Bacillus anthracis or at risk for infection with B. anthracis. The compositions include and the methods utilize isolated or purified equine antisera against B. anthracis.

Abstract: Compositions and methods effective for eliciting an immune response for preventing or reducing infection or improving clinical outcomes caused by Bacillus anthracis are provided. The compositions include a naturally occurring or synthetic protein, peptide, or protein fragment containing all or an active portion of an antigenic epitope associated with anthrax toxin proteins optionally combined with a pharmaceutically acceptable carrier. The preferred antigenic epitopes correspond to immunogenic regions of protective antigen, lethal factor or edema factor, either individually or in combination. In addition, methods and compositions containing antibodies for reducing the effects of anthrax toxins are described. The methods involve administering to a human or animal the compositions described herein in a dosage sufficient to elicit an immune response or treat the anthrax infection.

Abstract: The present disclosure relates to a method of preventing or treating an infection caused by a bioterrorism agent, specifically to a method of increasing an immune response to a bioterrorism agent using an oligodeoxynucleotide including a CpG motif, and a method of enhancing the immunogenicity of a vaccine against a bioterrorism agent using an oligodeoxynucleotide including a CpG motif.

Abstract: The invention relates to improved methods of producing and recovering B. anthracis protective antigen (PA), especially modified PA which is protease resistant, and to methods of using of these PAs or nucleic acids encoding these PAs for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of, B. anthracis bacterial infections and which are useful to prevent and/or treat illnesses caused by B. anthracis, such as inhalation anthrax, cutaneous anthrax and gastrointestinal anthrax.

Abstract: A stable lyophilized protein formulation containing recombinant Protective Antigen (rPA) is described that can be reconstituted with a suitable diluent to generate a high potency protein concentration reconstituted formulation which is suitable for use as a vaccine against anthrax infection in mammals, especially human beings. These formulations were prepared by lyophilizing rPA in the presence of a reducing sugar, such as trehalose, and methods of such lyophilization are described. The resulting lyophilized mixture or composition is subsequently reconstituted to high immunogenicity without apparent loss of stability of the rPA protein. Methods of using said formulations in vaccination are also described.

Abstract: The present invention relates to methods for producing microbial preparations for crop production and microbial preparations produced through such methods. The formulations contain microbial inoculants like Azospirillum spp. which are grown in a complex medium, lyophilized with powdered milk and further supplemented with minerals and vitamins, starch and inert substances such as talc, chalk and diatomaceous earth. The products manufactured by such methods have shelf-lives of more than 3 years. They are used to inoculate seeds, seedlings and planting materials among different agriculture and forestry species for enhancing root, root hair an shoot formation, enabling plants to efficiently use soil nutrients, supplying plants with nitrogen from the air, tolerating drought and protecting plants from root pathogenes.

Abstract: Compositions and methods effective for eliciting an immune response for preventing or reducing infection or improving clinical outcomes caused by Bacillus anthracis are provided. The compositions include a naturally occurring or synthetic protein, peptide, or protein fragment containing all or an active portion of an antigenic epitope associated with anthrax toxin proteins optionally combined with a pharmaceutically acceptable carrier. The preferred antigenic epitopes correspond to immunogenic regions of protective antigen, lethal factor or edema factor, either individually or in combination. In addition, methods and compositions containing antibodies for reducing the effects of anthrax toxins are described. The methods involve administering to a human or animal the compositions described herein in a dosage sufficient to elicit an immune response or treat the anthrax infection.

Abstract: The present invention provides compositions useful in preparing and/or serving as antitoxins against Bacillus anthracis, the causative agent of anthrax. The present invention also provides polypeptides and polynucleotides relating to the capillary morphogenisis gene 2 (CMG-2), vectors containing the polynucleotides and polypeptides, and host cells containing related polynucleotide molecules, all used in association with the treatment of, or the research and development of treatments for anthrax. The present invention also relates to methods for identifying molecules that bind CMG-2 and molecules that reduce the toxicity of anthrax toxin. Finally, the present invention provides methods for treating human and non-human animals suffering from anthrax.

Abstract: The invention is related to intracellularly induced bacterial DNA promoters and vaccines against Bacillus anthracis.

Abstract: The present invention relates to the use of an alpha-defensin in the manufacture of a medicament for the treatment, amelioration or prevention of a disease caused by Bacillus anthracis (B anthracis) infection. Furthermore, methods for the treatment of an B. anthracis infection as well as methods of protection against a B. anthracis infection, e.g. a vaccination are described.

Abstract: Disclosed herein are compositions for the treatment of a disease in an animal including yeast extract of Saccharomyces cerevisiae, Bacillus licheniformis or Bacillus subtilis spores, and a carrier. Also included are animal feed compositions including the composition for the prevention, control and/or treatment of a disease in an animal and an animal's food/feed. The compositions are useful to prevent, control, and treat diseases such as necrotic enteritis in poultry when used in combination with an anticoccidal ionophore or coccidiosis vaccine.

Abstract: The unnatural amino acid analogue 2-fluorohistidine (2-FHis) was incorporated into protective antigen to produce a protein which resists protonation at physiological pH by reducing the side-chain pKa. The protein structure was unperturbed by the incorporation of fluorinated histidine residues, and the heptameric (2-FHisPA63)7 could form ion conducting channels, and bind to the PA-binding domain of LF (LFN), but translocation of LFN in planar lipid bilayers was blocked. Further, while (2-FHisPA63)7 could bind to host cells and in vitro to the host cellular receptor, pore formation in the presence of the receptor was blocked, and LFN-DTA mediated cytotoxicity in CHO-K1 cells was blocked. The modified PA is useful as both a vaccine and an antitoxin, providing epitopes for the production of antibodies against PA, but preventing key steps in pathogenesis (pore formation, translocation).

Abstract: A method of treating irritable bowel syndrome using a probiotic composition including the bacilli (1) Bacillus subtilis, (2) Bacillus coagulans, and (3) Enterococcus faecium. The composition may further include a carrier medium, such as fructo-oligo-saccharides (FOS), as incorporated in a dose form such as a pill, capsule, powder or sachet. The compositions of the invention may be usefully employed as health or nutritional supplements, food additives, or therapeutic agents for combating a wide variety of physiological disorders.

Abstract: A DNA vaccine suitable for eliciting an immune response against cancer cells comprises a polynucleotide construct operably encoding an a Fra-1 protein, such as a polyubiquitinated human Fra-1 protein, and IL-18, such as human IL-18, in a pharmaceutically acceptable carrier. In a preferred embodiment, the polynucleotide construct is operably incorporated in an attenuated bacterial vector, such as an attenuated Salmonella typhimurium, particularly a doubly attenuated aroA- dam- S. typhimurium. Transformed host cells, methods of inhibiting tumor growth, of vaccinating a patient against cancer, and of delivering genetic material to a mammalian cell in vivo are also described.

Abstract: Producing an immunostimulating composition containing lactic acid bacteria having IL-12 production-inducing activity, by culturing lactic acid bacteria belonging to the genus Lactobacillus, immediately killing the bacteria at the point of time at which the pH of the culture medium substantially stops decreasing, and then adding the obtained killed cells to a food-or-drink product.

Abstract: Compositions and methods for the detection, prevention, or treatment of anthrax or other infectious diseases. In one aspect, the present invention provides methods for immunizing humans or animals against Bacillus anthracis or other capsulated pathogens. The methods include administering a capsular polypeptide of a pathogen of interest and a CD40 agonist to a human or animal. The capsular polypeptide or the CD40 agonist is administered in such an amount or frequency that an immunoprotective response can be elicited in the human or animal against the pathogen of interest. In another aspect, the present invention provides methods of using passive immunization with anti-capsular polypeptide antibodies to prevent or treat infections caused by Bacillus anthracis or other pathogens. In yet another aspect, the present invention provides methods useful for diagnosis of anthrax by detection of capsular polypeptide in serum or other biological samples.

Abstract: The invention features methods for increasing or maintaining the number of functional cells of a predetermined type in a mammal (e.g., a human patient), for example, the insulin producing cells of the pancreas, liver cells, spleen cells, or bone cells, that has injured or damaged cells of the predetermined type or is deficient in cells of the predetermined type.

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: Spore coat-associated proteins from members of Bacillus genera, and in particular spore-coat associated protein N (CotN), have utilisation as adjuvants in vaccine formulations. The vaccine formulations most likely contain a virulence factor of bacterial origin, which in the case of Bacillus genera is the protective antigen.

Abstract: A composition comprised of one or more bacterial proteins that are conserved among members of Bacillus cereus that is capable of inducing an immune response against members of Bacillus cereus group bacteria. The invention also relates to a method of utilizing the composition to induce an immune response.

Abstract: Methods for making and using therapeutic formulations of Proteosome-based immunoactive compositions are provided. The immunogenic compositions, which include Proteosomes and liposaccharides, may be used to elicit or enhance a nonspecific innate immune response to, for example, treat or prevent infectious disease. In addition, after activating the innate immune system, immunogenic compositions further containing an antigen may be used to elicit a specific adaptive immune response. Furthermore, provided are compositions capable of altering hyperreactive responses or inflammatory immune responses, such as allergic reactions. Such compositions may be used as a prophylactic, or in various clinical settings to treat or prevent infectious disease (such as parasite, fungal, bacterial or viral infections), or to alter inappropriate inflammatory immune responses (such as allergic reactions or asthma).

Abstract: Certain zwitterionic polysaccharides, including those naturally expressed by commensal B. fragilis in the gut, interact with cells of the immune system and affect the TH1/TH2 balance so as to promote health. Nutritional formulas and nutritional supplements containing isolated preparations of such zwitterionic polysaccharides, and methods for preparing the nutritional formulas and supplements, are provided. Also provided is a method of promoting immune system maturation in an infant involving enteral administration of a nutritional formula or nutritional supplement of the invention.

Abstract: A method of inhibiting bacterial cell growth or of treating or inhibiting a bacterial infection in a subject by administering to the subject a therapeutically effective amount of a polynucleotide encoding a polypeptide having ?/? small acid-soluble spore protein (SASP) activity in a delivery system which targets a bacterial cell.

Abstract: Disclosed is a vaccine that includes a dendritic cell loaded with a yeast vehicle and antigen. Also disclosed are methods of making the vaccine and using the vaccine to elicit cellular and humoral immune responses in a mammal. Additionally, a method to elicit an immune response by administration of a yeast vehicle and an antigen that is not complexed to the yeast vehicle is disclosed.

Abstract: Disclosed is a composition for administration to a human or animal subject, the composition containing spores of Bacillus subtilis in an amount effective to stimulate immune responsiveness in the subject. The spores have an adjuvant, immunomodulatory, immune potentiation, or dendritic cell maturation effect, or a combination thereof Also disclosed is a method of boosting an immune response in an animal subject by administering B. subtilis spores to an animal or human subject. Further disclosed is a vaccine containing B. subtilis spores, in the presence or absence of an antigen.

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 system, method and computer program product for controlling disease at an end user location, including (a) testing a range of candidates including at least one of: (i) Bacillus species, (i) Bacillus strains, (iii) species of beneficial bacteria (iv) strains of beneficial bacteria and (v) strains of beneficial bacterial viruses, against samples including at least one of pathogenic Vibrio, Gram negative pathogenic bacteria and Gram positive pathogenic bacteria taken from an end user location; (b) performing at least one of the following steps: (i) selecting one or more of the candidates that one of inhibit and attack at least one of the samples by direct inhibition of at least one of in situ antibiotic production, competitive exclusion, production of enzymes that degrade quorum sensing molecules, and (ii) testing a range of quorum sensing inhibitor compounds against the samples; and (c) performing the steps (a) and (b) for the end user location, including one of a country, major region and individual end user

Abstract: The invention provides nucleic acids, and variants and fragments thereof, obtained from strains of Bacillus thuringiensis encoding polypeptides having pesticidal activity against insect pests, including Coleoptera. Particular embodiments of the invention provide isolated nucleic acids encoding pesticidal proteins, pesticidal compositions, DNA constructs, and transformed microorganisms and plants comprising a nucleic acid of the embodiments. These compositions find use in methods for controlling pests, especially plant pests.

Abstract: The invention provides nucleic acids, and variants and fragments thereof, obtained from strains of Bacillus thuringiensis encoding polypeptides having pesticidal activity against insect pests, including Lepidoptera. Particular embodiments of the invention provide isolated nucleic acids encoding pesticidal proteins, pesticidal compositions, DNA constructs, and transformed microorganisms and plants comprising a nucleic acid of the embodiments. These compositions find use in methods for controlling pests, especially plant pests.

Abstract: Compounds, methods for identifying compounds and methods for using compounds which modulate interaction of lethal factor and anthrolysin O in the treatment and prevention of anthrax diseases are provided.

Abstract: The invention relates to a novel alkaline protease of the subtilisin type from Bacillus sp. (DSM 14392) and various related proteins and derivatives thereof. The invention further relates to washing and cleaning agents comprising novel alkaline proteases of the subtilisin type, various related proteins and derivatives thereof and corresponding washing and cleaning methods and use thereof in washing and cleaning agents and further technical applications.

Abstract: The present invention is based on a Bacillus the spores and vegetative cells forms of which are a different colour because of differential presence of at least one carotenoid in the spore and vegetative cell forms of the Bacillus. The Bacillus may therefore be used in detection methods and biosensors. The Bacillus may also be used a colourant and a dye and in the generation of foods, food supplements, probiotic compositions, dyes, cosmetic, pharmaceuticals and vaccines. The Bacillus may also be used for the production of carotenoids, precursors thereof and downstream derivatives.

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: The present invention discloses compositions derived from an isolated Bacillus species spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain, suitable for topical application to the skin or mucosal membranes of a mammal, which are utilized to inhibit the growth of bacterium, yeast, fungi, virus, and combinations thereof. The present invention also discloses methods of treatment and therapeutic systems for inhibiting the growth of bacterium, yeast, fungi, virus, and combinations thereof, by topical application of therapeutic compositions which are comprised, in part, of isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain.

Abstract: The invention is relates to drugs on the basis of antibodies against non-cellular bone matrix proteins, especially BSP, for use in the prevention and treatment of bone metastases. According to the invention, the antibodies are induced in the patient by recombinantly expressing antigenic determinants of bone matrix proteins in Listeria and anchoring them on the surfaces thereof. The antigenic determinants are selected according to whether they are characteristic of antigens that are expressed by the tumor cells themselves.

Abstract: The present invention discloses compositions derived from an isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain, suitable for topical application to the skin or mucosal membranes of a mammal, which are utilized to inhibit the growth of bacterium, yeast, fungi, virus, and combinations thereof. The present invention also discloses methods of treatment and therapeutic systems for inhibiting the growth of bacterium, yeast, fungi, virus, and combinations thereof, by topical application of therapeutic compositions which are comprised, in part, of isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain.

Abstract: Methods for improving binding of a proteinaceous substance to cell-wall material of a Gram-positive bacterium are disclosed. The proteinaceous substance includes an AcmA cell-wall binding domain, homolog or functional derivative thereof. The method includes treating the cell-wall material with a solution capable of removing a cell-wall component such as a protein, lipoteichoic acid or carbohydrate from the cell-wall material and contacting the proteinaceous substance with the cell-wall material.

Abstract: The present invention relates to growth-inhibitory composition against pathogenic bacteria of meat based food stuff comprising IgY, a specific immunoglobulin derived from yolk of egg. The 12 representative bacteria and other microbes deteriorating quality of process meat products that the IgY of the present invention targets include Aeromonas hydrophila, Bacilluis cereus, Campylobacter jejuni, Clostridium perfringens, 0157: H7 (Escherichia coli 0157:H7), Lactobacillus, Listeria monocytogens, Sacromyces cerevisae, Salmonella enteritidis, Salmonella typhimurium, Staphylococcus aureus, and Staphylococcus epidermidis. As the form of antigen, the 12 bacteria are injected to chickens separately to obtain IgY of the present invention against the 12 pathogens.

Abstract: An immunogenic reagent which produces an immune response which is protective against Bacillus anthracis, said reagent comprising one or more polypeptides which together represent up to three domains of the full length Protective Antigen (PA) of B. anthracis or variants of these, and at least one of said domains comprises domain 1 or domain 4 of PA or a variant thereof. The polypeptides of the immunogenic reagent as well as full length PA are produced by expression from E. coli. High yields of polypeptide are obtained using this method. Cells, vectors and nucleic acids used in the method are also described and claimed.

Abstract: Disclosed is a newly identified and characterized type III secretion system in Aeromonas salmonicida. The invention also encompasses the use of components of the novel secretion system in immunoprotection against A. salmonicida infection, as well as other diagnostic and therapeutic uses thereof.

Abstract: The present invention provides methods for eliciting an effective immune response against a weakly immunogenic disease or for priming T cells to become memory T cells against a weakly immunogenic disease by directly vaccinating into the bone marrow of the patient an antigen associated with the weakly immunogenic disease. Also included in the present invention is an isolated population of human memory CD8+ T cells from the bone marrow which is in a heightened activation state with a unique effector phenotype.

Abstract: The invention concerns an acellular immunogenic or vaccine composition for producing antibodies against Bacillus anthracis comprising a protective antigen (PA) and killed and optionally purified spores, obtained from mutating strains of Bacillus anthracis and their uses.

Abstract: The present invention concerns spore display methods. More specifically, the invention concerns display of heterologous molecules, such as peptides and polypeptides, on spores of bacilli, such as, for example, Bacillus thuringiensis (Bt) or Bacillus cereus (BC), using externally exposed spore coat proteins or fragments or variants thereof.

Abstract: The present invention is based on the discovery that protective antigen related molecules (PARMs) without anthrax lethal factor have antiangiogenic or anticancer properties. The invention is directed to a method of inhibiting an angiogenic disease/disorder or cancer. Additionally, the invention can be applied to those at risk for developing cancer or an angiogenic disease/disorder comprising administering to a mammal an angiogenesis-inhibiting or cancer inhibiting amount of an PARM (including analogs, or derivative thereof having angiogenesis-inhibiting or anticancer activity, consisting of PA, PA fragment, analog, or derivative that is administered in a composition substantially free of anthrax lethal factor or other toxins).

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 includes compositions and methods of detection of Bacillus anthracis that use oligonucleotide probes specific for genetic material contained in the pXO1 and pXO2 plasmids in nucleic acid hybridization reactions. Embodiments of the method may include additional probes specific for other gene sequences to distinguish B. anthracis from other bacterial species present in a sample or to provide an indication that the assay was performed properly even when no Bacillus sequence is detected.

Abstract: The invention concerns an acellular immunogenic or vaccine composition for producing antibodies against Bacillus anthracis comprising a protective antigen (PA) and killed and optionally purified spores, obtained from mutating strains of Bacillus anthracis and their uses.

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.