Abstract: Immunogenic compositions and kits, as well as methods of stimulating immune responses and methods of immunization using the same. The compositions and kits comprise: (a) an antigen derived from Bacillus anthracis; (b) polymer microparticles comprising a biodegradable polymer; and (c) a polynucleotide-containing immunological adjuvant.

Abstract: Rabies virus (RV) nucleoprotein (N) tightly encapsidates the genomic and antigenomic RNA thereby forming the ribonucleoprotein (RNP) complex. Antigens presented in a rigid and repetitive organization are sufficient to activate B cells to proliferate. In addition to the repetitive organization, it has been shown that RV N protein induces potent T-helper responses resulting in long-lasting and strong humoral immune responses against RV. The possibility to directly manipulate the genome of RV allows us to examine whether the immunogenicity of foreign antigens can be enhanced via incorporation into the RNP structure. A recombinant RV expressing an RV N-green fluorescent protein (GFP) fusion protein. The chimeric N-GFP fusion protein was efficiently expressed and incorporated into RV RNP and virions. Moreover, the recombinant RNP induces a strong humoral immune response against GFP in mice.

Abstract: The present invention pertains to the discovery that B. anthracis possesses a luxS gene that encodes a functional LuxS polypeptide, and that B. anthracis synthesizes a functional AI-2 quorum-sensing molecule. The invention provides mutant B. anthracis bacteria lacking the function of the luxS gene, which do not produce a functional AI-2 molecule and have growth defects compared to wild-type B. anthracis. The invention also concerns methods for inhibiting the growth of B. anthracis, or for preventing or treating B. anthracis infection, by inhibiting the activity of the B. anthracis LuxS polypeptide, or by exposure of the B. anthracis to furanone. In particular, the invention concerns the use of furanone, a compound that inhibits AI-2-mediated quorum-sensing, to inhibit the growth of B. anthracis, to inhibit B. anthracis toxin production, particularly that of protective antigen, and to prevent or treat B. anthracis infection. The invention also provides methods to prevent B.

Abstract: Described herein is a novel alkaline protease of the subtilisin type from Bacillus gibsonii (DSM 14391), as well as related proteins and derivatives thereof. Also described are washing and cleaning products comprising this novel alkaline protease, related proteins and derivatives thereof, as well as corresponding washing and cleaning products and methods, along with further possible technical uses.

Abstract: The present invention relates to mammalian anthrax toxin receptor polypeptides and polynucleotides encoding same as well as related polypeptides and polynucleotides, vectors containing the polynucleotides and polypeptides, host cells containing related polynucleotide molecules, and cells displaying no anthrax toxin receptor on an exterior surface of the cells—minus cell lines and animals. The present invention also relates to methods for identifying molecules that bind the anthrax toxin receptor 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 present invention relates to nanoparticle vaccine adjuvants comprised of a carrier, particularly polymerized lipids, having multiple copies of an antigen or combinations of different antigens displayed on the carrier. Such antigen-displaying nanoparticles may also display a targeting molecule on its surface in order to direct it to a specific site or cell type to optimize a desired immune response. The present invention also relates to encapsulating an antigen or combinations of different antigens within such nanoparticles, with or without a targeting molecule displayed on its surface. The antigens used in this invention are effective to produce an immune response against a variety of pathological conditions.

Abstract: The present invention is directed to methods for preparing a stable powder formulation of an alum-adsorbed vaccine. The methods comprise atomizing a liquid formulation comprising an immunogen adsorbed onto an aluminum adjuvant to produce an atomized formulation, freezing the atomized formulation to produce frozen particles, and drying the frozen particles to produce dried powder particles. Pharmaceutical compositions comprising a stable powder formulation of an alum-adsorbed vaccine are also disclosed herein. The pharmaceutical compositions are stable at high temperatures and can be reconstituted in a pharmaceutically acceptable carrier to produce a reconstituted liquid vaccine that exhibits little or no particle agglomeration and retains immunogenicity. Methods of using the alum-adsorbed vaccine compositions for preventing and treating a disease in a subject, wherein the disease is associated with the particular immunogen, are further provided.

Abstract: Methods for enhancing destruction and killing of bacterial spores via phagocytosis, where phagocytosis of bacterial spores is enhanced by using a glycoconjugate. In one embodiment, the method includes the steps of modifying a surface of a bacterial spore to increase adherence to a phagocyte; and ingesting the adherence-increased spore with the phagocyte, thereby destructing and killing the spore by blocking spore-induced phagocyte cell death, while increasing phagocyte activation level and production of antimicrobial and cytocidal agents such as NO and inflammatory cytokines. The adherence of spore to a phagocyte is increased after the surface thereof is coated with a glycoconjugate to form a glycoconjugate-coated spores. The glycoconjugate-coated spores also increase ingestion of the spores by phagocytes and facilitate phagosome-lysosome fusion, which in turn results in destruction and killing of bacterial spores via phagocytosis.

Abstract: The present invention is based on the provision of non-pathogenic Bacillus spores comprising: (i) a polynucleotide sequence encoding a phagosome membrane-rupturing agent; and (ii) a polynucleotide sequence encoding at least one further heterologous polypeptide. These may be used to deliver heterologous polypeptides to cells and in particular to phagocytic cells. Pharmaceutical compositions, vaccines and medicaments comprising the spores are provided and may be used for a variety of purposes including in immunisation and vaccination.

Abstract: This invention relates to novel penetrating compositions including one or more effectors included within a water soluble composition, immersed in a hydrophobic medium The invention also relates to methods of treating or preventing diseases by administering such penetrating compositions to affected subjects.

Abstract: This invention pertains to methods for detecting B. anthracis and antibodies to B. anthracis, the causative agent of anthrax, in a subject.

Abstract: A microparticle composition comprising a biodegradable polymer, an immunogenic single-stranded ribonucleic acid (ss-RNA) material, a biologically active macromolecule and a stabilising agent wherein the outer surface of the resulting microparticle is free from adsorbed molecules is described. The composition is effective in providing an immune response in dendritic cells, in particular by stimulating increased production of IFN-?. Methods of production and uses, in medicine, of pharmaceutical compositions derived from the microparticles are also claimed and described.

Abstract: The invention relates to a method for preventing or treating gastrointestinal infections in humans, which comprises administering a pharmaceutical preparation comprising, in combination with a pharmaceutically acceptable or food grade carrier, a therapeutically effective amount of at least one lactic acid bacteria strain of the genus L. acidophilus, L. crispatus, L. gasseri, L. helveticus and L. jensenii selected for their ability to kill urogenital and/or gastrointestinal pathogens and their ability to inhibit internalization of urogenital and/or gastrointestinal pathogens within gastrointestinal epithelial cells.

Abstract: A series of mutants of Anthrax lethal factor (LF) are disclosed which define a conformational epitope or region of the molecule that interacts with the LF target, the MEK enzyme. Such mutants or variants, and nucleic acids encoding them are disclosed. The knowledge of such binding, separate from recognition of MEK by the protease active site of LF, serves as the basis for novel screening assays for discovery of inhibitors of this additional form of LF-MEK binding which is necessary for ultimate proteolysis and toxicity. The nontoxic LF mutants are useful as immunogenic compositions for generating antibodies and a state of immunity specific for the LF component of a B. arithracis infection or exposure otherwise to the anthrax lethal toxin.

Abstract: This invention pertains to methods for detecting B. anthracis and antibodies to B. anthracis, the causative agent of anthrax, in a subject.

Abstract: This invention provides novel methods, reagents, and kits that are useful for detecting B. anthracis. The methods are based on the discovery of binding agents, including recombinant polyclonal antibodies, which bind to the surface array protein of B. anthracis.

Abstract: The invention features methods and compositions for treatment or prevention of infection by, or disease caused by infection with, certain species of bacteria, including in particular bacteria in which a RAP-type and/or TRAP-type molecule plays a role in pathogenesis. This includes Staphylococcus species.

Abstract: The present invention provides a process for efficiently producing sporangia of Bacillus popilliae containing spores and parasporal bodies having controlling effects on Scarabaeidae insects, and a control agent and controlling method for Scarabaeidae insects obtained by said production process. In a process for producing sporangia of Bacillus popilliae containing spores and parasporal bodies by culturing Bacillus popilliae in a medium containing an adsorbent, the medium contains 0.2-4.0% by weight of glutamic acid.

Abstract: The present invention relates to nanoparticle vaccines comprised of a carrier, particularly polymerized lipids, having multiple copies of an antigen or combinations of different antigens displayed on the carrier. Such antigen-displaying nanoparticles may also display a targeting molecule on its surface in order to direct it to a specific site or cell type to optimize a desired immune response. The present invention also relates to encapsulating an antigen or combinations of different antigens within such nanoparticles, with or without a targeting molecule displayed on its surface. The antigens used in this invention are effective to produce an immune response against a variety of pathological conditions.

Abstract: This invention relates to a novel mycobacterial protein named DES, which appears to share significant amino acid sequence homology with soluble stearoyl-ACP desaturases. The results of allelic exchange experiments, indicate that the des gene may be essential to the survival of mycobacteria. These results coupled with the surface localization, the unique structure of DES, and the fact this antigen is expressed in vivo, and DES protein induces a humoral response in human patients, indicate that the DES protein provides a new target for the design of anti-mycobacterial drugs. This invention provides methods of screening molecules that can inhibit the DES enzyme activity of purified DES protein, in order to identify antibiotic molecules that are capable of inhibiting the growth or survival of mycobacteria.

Abstract: The invention relates to improved methods of producing and recovering sporulation-deficient B. anthracis mutant stains, and for producing and recovering recombinant 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: 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: Recombinant immunogenic compositions and methods for protecting against lethal infections from Bacillus anthracis having a variant of recombinant Bacillus anthracis protective antigen (rPA) and a variant of recombinant Bacillus anthracis lethal factor (rLF). These proteins may be expressed separately or as a fusion protein. The recombinant proteins are produced in an avirulent strain of Bacillus anthracis that overproduces the desired antigens. The compositions and methods induce the animal host to produce antibodies against a virulent strain of Bacillus anthracis.

Abstract: Isolated peptides of the Bacillus anthracis Anthrax Toxin Lethal factor Protein pX01–107, antibodies specific for the peptides and methods of stimulating the immune response of a subject to produce antibodies to the Bacillus anthracis Anthrax Toxin Lethal factor Protein pX01–107 are disclosed. Also disclosed are isolated peptides of the Small Pox Virus Surface Antigen S Precursor Protein, antibodies specific for the peptides and methods of stimulating the immune response of a subject to produce antibodies to the Small Pox Virus Surface Antigen S Precursor Protein.

Abstract: The invention provides mutant forms of pore-forming toxins. These mutant toxins may be used in vaccines for the prevention of bacterial infection. Additionally, dominant negative mutants may be administered as therapeutics for the treatment of bacterial infection.

Abstract: The invention concerns bacteria strains, obtained from gram-positive bacteria whereof the genome size is not more than 3.2 Mb, and wherein the HtrA surface protease is inactive. Said strains are useful for expressing exported proteins of interest.

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: Disclosed are novel synthetically modified B. thuringiensis chimeric crystal proteins having improved insecticidal activity against coleopteran, dipteran and lepidopteran insects. Also disclosed are the nucleic acid segments encoding these novel peptides. Methods of making and using these genes and proteins are disclosed as well as methods for the recombinant expression, and transformation of suitable host cells. Transformed host cells and transgenic plants expressing the modified endotoxin are also aspects of the invention.

Abstract: The present invention relates to novel amylolytic enzymes having improved characteristics for the use in starch degradation, in textile or paper desizing and in household detergent compositions. The disclosed ?-amylases show surprisingly improved properties with respect to the activity level and the combination of thermostability and a higher activity level. These improved properties make them more suitable for the use under more acidic or more alkaline conditions. The improved properties allow also the reduction of the Calcium concentration under application conditions without a loss of performance of the enzyme.

Abstract: The invention overcomes the deficiencies of the prior art by providing antibody compositions having improved affinities for Bacillus anthracis antigens. The compositions have important thereapeutic and diagnostic applications, including treatment or detection of infection by Bacillus anthracis.

Abstract: The present invention provides monoclonal antibodies which are highly specific for Bacillus spores. Also provided are peptides derived from those monoclonal antibodies. Both the antibodies and peptides are highly specific and can discriminate between spores of potentially lethal organisms such as Bacillus anthracis and other harmless but closely related bacilli and provide a very powerful tool in the construction of detection instruments as counter measures.

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 present invention relates to a method of inducing a CD8+ CTL response to a molecule in an individual deficient in CD4+ T cells comprising administering to the individual an hsp or a portion of an ATP binding domain of an hsp joined to the molecule. In one embodiment, the present invention relates to a method of treating HIV in an individual deficient in CD4+ T cells comprising administering to the individual an hsp or a portion of an ATP binding domain of an hsp joined to the molecule. Also encompassed by the present invention is a method of inducing a CD4+ independent CTL response in an individual comprising administering to the individual a portion of an ATP binding domain of an hsp joined to the molecule. The present invention also relates to a method of inducing a CD8+ CTL response in an individual comprising administering to the individual a portion of an ATP binding domain of an hsp joined to the molecule.

Abstract: This invention provides novel methods, reagents, and kits that are useful for detecting B. anthracis. The methods are based on the discovery of binding agents, including recombinant polyclonal antibodies, which bind to the surface array protein of B. anthracis.

Abstract: Methods are disclosed for immunizing a mammal against B. anthracis using a composition of pure recombinant Protective Antigen (rPA), optionally in combination with truncated Lethal Factor polypeptide (LFn). Formulations of the pure rPA immunogen have little or no reactogenicity and therefore may be administered to a mammalian subject in very high doses of 50 &mgr;g to 1000 &mgr;g or more rPA, which is at least four times the amount of PA included per dose in conventional anthrax vaccines. Preferred immunogenic compositions are free of adjuvant and other undesired components, further enhancing the effectiveness and safety of the compositions. Methods for preparing the immunogenic compositions and for purifying rPA and LFn polypeptides also are disclosed.

Abstract: The subject invention concerns materials and methods useful in the control of non-mammalian pests and, particularly, plant pests. In a specific embodiment, the subject invention provides new Bacillus thuringiensis toxins useful for the control of lepidopterans. The subject invention further provides nucleotide sequences which encode the toxins of the subject invention. The nucleotide sequences of the subject invention can be used to transform hosts, such as plants, to express the pesticidal toxins of the subject invention. The subject invention further concerns novel nucleotide primers for the identification of genes encoding toxins active against pests. The primers are useful in PCR techniques to produce gene fragments which are characteristic of genes encoding these toxins. The primers are also useful as nucleotide probes to detect the toxin-encoding genes.

Abstract: An animal-derived lipid is disclosed that is useful as a carrying agent for anti-microbial formulations. Pharmaceutical and other preparations including Emu Oil are also described as profoundly useful components in anti-bacterial, anti-fungal, and anti-viral treatments. This lipid material is extracted from the Emu (Dromais Novae-Hollandiae), an indigenous bird of Australia and New Zealand. The present invention also discloses therapeutic compositions comprising Emu Oil in combination with an extracellular product of Bacillus coagulans or Pseudomonas lindbergii strain, comprising a supernatant or filtrate of said culture 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. Additionally, the aforementioned therapeutic composition may also include an anti-microbial, anti-mycotic, and/or anti-viral agent.

Abstract: A bacterial translocation inhibitor containing live Bacillus subtilis cells as an active ingredient, and a method for inhibiting bacterial translocation comprising the step of orally administering the bacterial translocation inhibitor.

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: Disclosed are novel synthetically-modified B. thuringiensis chimeric crystal proteins having improved insecticidal activity and broader insect host range against coleopteran, dipteran and lepidopteran insects. Also disclosed are the nucleic acid segments encoding these novel peptides. Methods of making and using these genes and proteins are disclosed as well as methods for the recombinant expression, and transformation of suitable host cells. Transformed host cells and transgenic plants expressing the modified endotoxin are also aspects of the invention.

Abstract: Disclosed, are novel synthetically-modified B. thuringiensis chimeric crystal proteins having improved insecticidal activity against coleopteran, dipteran and lepidopteran insects. Also disclosed are the nucleic acid segments encoding these novel peptides. Methods of making and using these genes and proteins are disclosed as well as methods for the recombinant expression, and transformation of suitable host cells. Transformed host cells and transgenic plants expressing the modified endotoxin are also aspects of the invention.

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: Provided is a bacteriostatic composition for salmonellae containing, as the active ingredient, a fermented broth obtained by effecting fermentation with the use of a lactic acid bacteriium belonging to the genus Leuconostoc, Streptococcus or Streptobacterium in a sucrose-containing medium, or a preparation originating in the supernatant obtained by subjecting the fermented broth to fractional precipitation from a water-miscible organic solvent.

Abstract: The present invention provides a vaccine for inducing an immune response in mammal to a specific antigen, where the vaccine comprises a unit dose of a binary toxin protective antigen and the antigen, which is bound to a binary toxin protective antigen binding protein. In one embodiment the vaccine is comprised of an anthrax protective antigen and the antigen bound to anthrax protective antigen binding protein. The present invention also provides a method of immunizing a mammal against an antigen using the vaccine, and a method of inducing antigen-presenting mammalian cells to present specific antigens via the MHC class I processing pathway.

Abstract: The invention includes methods and compositions for treating an animal to inhibit the incidence and growth of E. coli O157:H7 and other pathogenic bacteria. The treatment method comprises administering a therapeutically effective amount of Lactobacillus acidophilus or one or a combination of a number of other probiotic bacteria to an animal. An alternative treatment method comprises administering a therapeutically effective amount of a lactic acid producing bacterium such as Lactobacillus acidophilus in combination with a lactate utilizing bacterium such as Propionibacterium freudenreichii.

Abstract: The invention includes methods and compositions for treating an animal to inhibit the incidence and growth of E. coli O157:H7 and other pathogenic bacteria. The treatment method comprises administering a therapeutically effective amount of Lactobacillus acidophilus or one or a combination of a number of other probiotic bacteria to an animal. An alternative treatment method comprises administering a therapeutically effective amount of a lactic acid producing bacterium such as Lactobacillus acidophilus in combination with a lactate utilizing bacterium such as Propionibacterium freudenreichii.

Abstract: The invention includes methods and compositions for treating an animal to inhibit the incidence and growth of E. coli O157:H7 and other pathogenic bacteria. The treatment method comprises administering a therapeutically effective amount of Lactobacillus acidophilus or one or a combination of a number of other probiotic bacteria to an animal. An alternative treatment method comprises administering a therapeutically effective amount of a lactic acid producing bacterium such as Lactobacillus acidophilus in combination with a lactate utilizing bacterium such as Propionibacterium freudenreichii.

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 a vaccine for inducing an immune response in mammal to a specific antigen, where the vaccine comprises a unit dose of a binary, cytotoxic T lymphocyte vaccine comprising an anthrax protective antigen and a full length protein antigen bound to a nontoxic anthrax protective antigen binding protein comprising at least about the first 250 amino acid residues of the lethal factor of Bacillus anthracis and less than all of the amino acid residues of the lethal factor. The present invention also provides a method of immunizing a mammal against an antigen using the vaccine, and a method of inducing antigen-presenting mammalian cells to present specific antigens via the MHC class I processing pathway.

Abstract: A method of treatment of severe anthrax infection particularly inhalation pneumonia or gastrointestinal anthrax antigen by the passive transfer to infected patients of plasma or plasma fractionated derivatives, such as gammaglobulins or antibodies, monclonal or polyclonal, with high titer neutralizing antibodies against Bacillus anthracis or its toxins. The plasma or fractionated plasma derivatives are derived from previously vaccinated individuals with anthrax vaccine, or any antigen or toxin antigen of Bacillus anthracis, including protective antigen (PA), lethal factor (LF) and/or oedema factor (OF).