Abstract: The present invention includes compositions and methods for the use of an encapsulation additive having between about 0.1 to about 30 percent isolated and purified vitelline protein B to provide for mixed and extended release formulations.

Abstract: Methods and compositions for the treatment of Brucella induced diseases and disorders are disclosed herein. In preferred embodiments, the invention relates to vaccines. In additional embodiments, the invention relates to formulations capable of releasing said vaccines at a controlled rate of release in vivo. In further embodiments, the invention relates to modified strains of the bacteria Brucella melitensis and Brucella abortus. In still further embodiments, the invention relates to compositions that do not induce clinical symptoms or splenomegaly in a subject receiving said compositions.

Abstract: Described herein are microorganisms that are modified so that they have an increased ability to be recognized by the innate immune system of a eukaryote, relative to an unmodified microorganism. A microorganism may be a gram-negative bacterium that has been modified to produce high potency lipopolysaccharide, e.g., Yersinia pestis expressing LpxL. Such modified microorganisms may be used as vaccines for protection against an infection by the unmodified microorganism. They may also be used as delivery vehicles of one or more heterologous antigens, e.g., antigens from pathogens or those associated with a hyperproliferative eukaryotic cell.

Abstract: Brucellosis is a disease caused by facultative intracellular bacteria of the monospecific genus Brucella melitensis. The invention in one aspect is an immunogenic nucleic acid composition comprising DNA encoding Brucella melitensis Invasion Protein B, a polypeptide with at least 95% identity thereto, or an immunologically active fragment of either of these, and an adjuvant. In another aspect, the invention is a DNA vaccine composition comprising a plasmid vector having DNA encoding a polypeptide as recited above, in which said plasmid vector is adsorbed to a liposome. Other aspects of the invention include methods of inducing an enhanced immune response to Brucella infection in an animal, methods for the differential diagnosis in an animal of brucellosis and vaccination by an immunogenic nucleic acid composition having DNA encoding any of the above-recited polypeptides, and a kit for conducting said differential diagnosis methods.

Abstract: The invention relates to Gram-negative bacteria carrying an inactivated gene encoding a glycosyltransferase involved in the synthesis of the core of the LPS of said Gram-negative bacteria, wherein said inactivated gene results in the synthesis of a LPS having a modified core. These strains have an attenuated virulence but induce a humoral immunity sufficient for ensuring vaccination of the host.

Abstract: Probiotic Bifidobacterium strain AH1205 or mutants or variants thereof are immunomodulatory following oral consumption and are useful in the prophylaxis and/or treatment of inflammatory activity such as undesirable gastrointestinal inflammatory activity for example inflammatory bowel disease.

Abstract: Compositions and methods for the diagnosis and prevention of B. abortus infection are provided.

Abstract: The subject invention provides a novel and advantageous strain of Pasteuria bacteria with nematicidal activity against Reniform nematodes. The subject invention provides the novel bacteria culture referred to as ATCC PTA-9643, and mutants thereof. Also provided are nematicidal compositions comprising the Pasteuria strain or its mutants or variants and methods for treating phytopathogenic and soil-dwelling nematodes.

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: Disclosed are methods and compositions for treating or preventing microbial infections.

Abstract: The methods and compositions of the present invention are directed to a vaccine against Vibrio cholerae comprised of V. cholerae outer membrane vesicles (OMVs). Such vaccines are relatively stable, facilitating distribution. Inventive methods generally include administration of a vaccine against Vibrio cholerae by intranasal, intraperitoneal, oral or intragastric routes. Such vaccines confer immunity to the individual, and when administered to pregnant subjects, can be conferred to the offspring of individuals.

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: Bifidobacterium strain AH1206 or mutants or variants thereof are immunomodulatory following oral consumption and are useful in the prophylaxis and/or treatment of inflammatory activity for example undesirable gastrointestinal inflammatory activity such as inflammatory bowel disease.

Abstract: An embodiment of the present invention features a dosage form for administering antigen to cause an immune response in an animal or human subject in the nature of a vaccine. The dosage form comprises spheres having an effective amount of antigen to create an immune response and having an average diameter of 0.01 to 10.0 microns. The spheres comprise a polymer selected from the group consisting of poly(L-lactic acid), poly(D, L-lactic acid), poly(glycolic acid) and carboxylic acid and ester derivatives thereof, poly(fumaric anhydride) and poly(sebacic anhydride) and derivatives thereof. The spheres can be lyophilized and stored as a powder prior to use. The spheres can then be reconstituted and formulated in buffers with adjuvants.

Abstract: The invention provides methods of formulating an anti-inflammatory composition for treating inflammatory conditions in a specific organ or tissue. The method involves selecting at least one pathogen that is pathogenic in the specific organ or tissue; producing an antigenic composition comprising antigenic determinants that together are specific for the pathogen; and formulating the antigenic composition for administration as an anti-inflammatory composition capable of eliciting an anti-inflammatory response in the specific organ or tissue. In embodiments of the invention the pathogen may be an endogenous pathogen, such as an endogenous bacterial pathogen. The pathogen may be an exogenous pathogen, such as a bacterial pathogen, viral pathogen, a fungal pathogen, or a helminth pathogen.

Abstract: The invention relates to Gram-negative bacteria carrying an inactivated gene encoding a glycosyltransferase involved in the synthesis of the core of the LPS of said Gram-negative bacteria, wherein said inactivated gene results in the synthesis of a LPS having a modified core. These strains have an attenuated virulence but induce a humoral immunity sufficient for ensuring vaccination of the host.

Abstract: The present invention includes compositions and methods for the use of an encapsulation additive having between about 0.1 to about 30 percent isolated and purified vitelline protein B to provide for mixed and extended release formulations.

Abstract: The present invention provides methods and compositions for the stimulation of immune responses. Specifically, the present invention provides nanoemulsion compositions harboring one or more immunogens within the oil phase of the nanoemulsion and methods of using the same for the induction of immune responses (e.g., innate and/or adaptive immune responses (e.g., for generation of host immunity against an environmental pathogen)). Compositions and methods of the invention find use in, among other things, clinical (e.g., therapeutic and preventative medicine (e.g., vaccination)) and research applications.

Abstract: Certain attenuated mutants of Brucella, especially B. melitensis, B. abortus, B. suis and B. ovis, when administered to a human or animal trigger a protective immune response such that subsequent challenge with virulent Brucella of the same species does not result in disease or results in much less severe symptoms. Functional inactivation of galE, a virB gene or the operon (ORFs 1087-1090) comprising the gene encoding ?-hexosaminidase (BMEI1087) and a lytic murein transglycosylase gene (BMEI1088). A specific example of the attenuated galE mutant which produces a protective immune response is B. melitensis GR024. The specific example of an inactivated ORF1087-1090 operon is B. melitensis GR026; it has an insertion mutation in the promoter region upstream of ORF 1090. Vaccination with live cells of either or both of these mutants results in a T cell response which protects the human or animal against challenge with virulent B. melitensis.

Abstract: The invention relates to antigenic compositions and to methods for immunising animals using same. The antigenic compositions comprises a lipid formulation most usually in solid form, and at least one antigenic component. A preferred antigenic component is a living organism. In a preferred embodiment the composition is formulated for oral administration.

Abstract: Compositions and methods for the diagnosis and prevention of B. abortus infection are provided.

Abstract: The invention relates to a bacterial antigen library of Brucella suis surface antigens, its preparation and use. The library comprises 205 surface protein genes of Brucella suis constructed in an expression vector. The library can be used to prepare recombinant Brucella surface antigens. The expressed proteins derived from the gene library are important for the development of new vaccines to prevent brucellosis, or diagnostic kits to detect Brucellosis. The proteins prepared from the gene library can also be used to prepare a protein array to investigate pathogenic mechanism of brucellosis.

Abstract: Immunogenic compositions comprising growth regulatable recombinant intracellular pathogens that have been transformed to express recombinant immunogenic antigens of the same or other intracellular pathogens are provided. Exemplary immunogenic compositions include, but are not limited to, growth regulatable and growth limited recombinant intracellular pathogen immunogenic compositions.

Abstract: The present invention provides non-toxic Gram-negative bacteria. In particular, the present invention provides viable Gram-negative bacteria (e.g., E. coli) substantially lacking lipopolysaccharide (LPS, endotoxin) within the outer membrane. The present invention further provides methods of generating viable non-toxic Gram-negative bacteria and uses thereof. The present invention also provides compositions and methods for inducing immune responses and for researching and developing therapeutic agents.

Abstract: This document relates to materials and methods for producing an immune response for reducing the risk of developing brucellosis. For example, this document provides vaccines for administration to animals as well as methods for producing an immune response against bacteria that cause brucellosis using vaccines provided herein. The vaccines provided herein can be effective for reducing the risk of developing brucellosis from multiple species of Brucella.

Abstract: Certain attenuated mutants of Brucella, especially B. melitensis, B. abortus, B. suis and B. ovis, when administered to a human or animal trigger a protective immune response such that subsequent challenge with virulent Brucella of the same species does not result in disease or results in much less severe symptoms. Functional inactivation of galE, a virB gene or the operon (ORFs 1087-1090) comprising the gene encoding ?-hexosaminidase (BMEI1087) and a lytic murein transglycosylase gene (BMEI1088). A specific example of the attenuated galE mutant which produces a protective immune response is B. melitensis GR024. The specific example of an inactivated ORF1087-1090 operon is B. melitensis GR026; it has an insertion mutation in the promoter region upstream of ORF 1090. Vaccination with live cells of either or both of these mutants results in a T cell response which protects the human or animal against challenge with virulent B. melitensis.

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: Free-living microbes are provided in which the nucleic acid has been modified so that the microbe is attenuated for proliferation and/or which comprise genetic mutations that attenuate the ability of the microbe to repair its nucleic acid. Methods of using the modified microbes for the loading, activation, and/or maturation of antigen-presenting cells are also provided. Vaccine compositions comprising the modified microbes and/or the antigen-presenting cells and methods of using the vaccines are also provided. The microbes may be further modified to include heterologous antigens, such as tumor antigens or infectious disease antigens, for use as a vaccine against cancer or infectious diseases.

Abstract: A mutant cholera holotoxin featuring a point mutation at amino acid 29 of the A subunit, wherein the glutamic acid residue is replaced by an amino acid other than aspartic acid, is useful as an adjuvant in an antigenic composition to enhance the immune response in a vertebrate host to a selected antigen from a pathogenic bacterium, virus, fungus or parasite. In a particular embodiment, the amino acid 29 is histidine. The mutant cholera holotoxin may contain at least one additional mutation in the A subunit at a position other than amino acid 29. The antigenic composition may include a second adjuvant in addition to the mutant cholera holotoxin.

Abstract: A recombinant, attenuated strain of Brucella suis or Brucella melitensis with a deficiency in carboxyl-terminal protease activity or tail-specific protease activity can be used as a vaccine for the prevention or treatment of Brucellosis. Prior exposure to the Brucella species is identified by detecting a genetic sequence for carboxyl-terminal (i.e. tail-specific) protease activity in a biological sample.

Abstract: Microbiological agents are provided for control of certain diseases of wheat and other cereals caused by Fusarium species, including Fusarium head blight of wheat and other cereals. These agents can also improve yield of wheat plants and cereals. The agents are novel isolates of Pantoea agglomerans and of Bacillus megaterium that exhibit the property of inhibiting fungal pathogens, particularly those produced by Fusarium species. Biocontrol compositions, and methods of using them to control plant pathogen development on wheat and cereal plants and for increasing plant yield, are also provided. The biocontrol compositions comprise a mixture of at least one microorganism selected from the group consisting of Pantoea agglomerans and Bacillus megaterium.

Abstract: The present invention provides a method of treating or preventing inflammation in a subject, comprising administering to the subject an effective amount of cholera toxin subunit B. The present invention also provides a method of decreasing the activity of interferon gamma in a subject, comprising administering to the subject an effective amount of cholera toxin subunit B. Further provided is a method of decreasing the activity of IL-12 in a subject, comprising administering to the subject an effective amount of cholera toxin subunit B. Additionally, the present invention provides a method of treating or preventing a Th1 T-cell mediated autoimmune disorder in a subject, comprising administering to the subject an effective amount of cholera toxin subunit B.

Abstract: Safe and effective live vaccines against Flavobacterium columnare of fish were created through the induction of rifampicin resistance in a native Flavobacterium columnare isolate; these including rifampicin-resistant mutants NRRL B-30303 and B-30304. Single immersion exposure of fish stimulated acquired immunity against virulent F. columnare infection.

Abstract: This invention relates to an over-expressing homologous antigen vaccine, a method of producing the same, and use of the vaccine for prophylaxis or treatment of vertebrates at risk of or suffering from disease caused by a pathogenic micro-organism. The vaccine is an attenuated or avirulent pathogenic micro-organism that over-expresses at least one homologous antigen encoded by at least one gene derived from the pathogenic micro-organism, and may also express a heterologous antigen.

Abstract: Isolated polynucleotide molecules contain a nucleotide sequence that encodes a L. intracellularis HtrA, PonA, HypC, LysS, YcfW, ABC1, or Omp100 protein, a substantial portion of the sequences, or a homologous sequence. Related polypeptides, immunogenic compositions and assays are described.

Abstract: The treatment of IBD in mammals, including humans, is described. More particularly, the present invention relates to compositions and methods for the treatment of IBD associated with Helicobacter or other bacterial infections in mammals, including humans, and to vaccine compositions and antibodies suitable for use in such treatment.

Abstract: A vaccine comprising a combination of Brucella “A” and “M” outer-polysaccharides (OPSs) and “R” protein antigens for enhancing immunity against brucellosis is disclosed. The OPS may be obtained from different strains or species of Brucellae (i.e. combining OPS extracted from different bacteria expressing “A” or “M” OPS, or combining OPS and OPS-protein complexes extracted from different bacteria). The OPS or OPS-protein complexes may also be obtained from a single strain expressing more than one OPS (e.g. from B. suis strain 145 which expresses “A”, “M” and possibly other OPSs). The vaccine according to the present invention overcomes the limitation of previously discovered B. abortus “A” OPS which only protects against species and strains of Brucella that had “A” OPS but not against others with different OPS.

Abstract: This invention relates to an over-expressing homologous antigen vaccine, a method of producing the same, and use of the vaccine for prophylaxis or treatment of vertebrates at risk of or suffering from disease caused by a pathogenic micro-organism. The vaccine is an attenuated or avirulent pathogenic micro-organism that over-expresses at least one homologous antigen encoded by at least one gene derived from the pathogenic micro-organism, and may also express a heterologous antigen.

Abstract: The present invention provides a method of attenuating swelling or inflammation in the tissue of a patient via applying a composition comprising a hydrophilic foam substrate and a polymeric hydrophilic agent capable of absorbing water to a portion of the surface of the skin of the patient in an amount and at a location sufficient to attenuate swelling or inflammation.

Abstract: Live Brucella vaccines and methods for preparing the live vaccines protective against brucellosis are described. The vaccines are prepared by introducing a deletion in the rfbU gene of a strain of Brucella which results in attenuation of the strain while retaining the desired immunogenicity to initiate a protective immunogenic response. Other strains with varying levels of attenuation are described.

Abstract: The present invention relates to the effects of bacterial polysaccharides on cell mediated immunity in animals. Polysaccharides of the present invention comprise the outer polysaccharides (OPS) located on bacterial cell membranes and other polysaccharides (e.g. “Poly B”) either secreted or contained within the periplasmic space. These polysaccharides have been found to enhance the general or cell mediated immunity of animals to various diseases. The invention provides for the use of such polysaccharides in preventing and treating various infections as well as in treating carcinomas. The invention also provides for synthetic polysaccharides having the same immuno-modulating effect as the bacterial polysaccharides.

Abstract: A bacteriophage linked to an enzyme can replace an antibody in a system for detecting the presence of a bacteria in a sample. Specifically Brucella abortus (a pathogen which causes brucellosis in cattle) can be detected using Brucella bacteriophage for the virus, urease for the enzyme linked to the bacteriophage, m-maleimidobenzoyl-N-hydrosysuccimide ester as a coupling reagent, sera from mice immunized with Brucella bacteriophage for a detector antibody, urease conjugated to anti-mouse sheep antibody for an indicator, and urea with bromcresol purple as the substrate. The materials can be used in indirect (sandwich) or direct enzyme-linked viral assays (ELVirA).

Abstract: Oral vaccine formulations are disclosed having microparticles sized such that at least 50% of the microparticles are less than 5 &mgr;m, preferably less than 3 &mgr;m, the microparticles containing antigen entrapped or encapsulated, such as by a solvent evaporation method, by a biodegradable polymer, such as poly (D,L-lactide-co-glycolide). Additionally, oral vaccine formulations are disclosed having nanoparticles sized such that at least 50% of the microparticles are less than 600 nm, preferably less than 500 nm, the nanoparticles containing antigen entrapped or encapsulated, such as by a coacervation method, by a biodegradable polymer, such as poly (D,L-lactide-co-glycolide). Protective vaccine formulations containing the B. pertussis antigens PTd or a combination of PTd and FHA are provided.

Abstract: The present invention relates to an isolated 17-kDa Brucclla antigen characterized by an amino acid sequence having at least 60% homology, preferably at least 70% homology, more preferably having at least 80% homology to the amino acid sequence as shown in SEQ ID No. 1 or 2, with said antigen being specifically recognized by sera from Brucella field infected individuals, more particulary an antigen characterized by the amino acid sequence as shown in SEQ ID No. 1 or 2. The invention also relates to recombinantly produced 17 kDa Brucella antigen, nucleic acids coding for the same and the use thereof in diagnostic and prophylactic methods and kits.

Abstract: A novel composition comprising Invaplex from gram-negative bacteria is described and is effective as a vaccine against gram-negative bacterial infection.

Abstract: Live Brucella vaccines and methods for preparing the live vaccines protective against brucellosis are described. The vaccines are prepared by introducing a deletion in the rfbU gene of a strain of Brucella which results in attenuation of the strain while retaining the desired immunogenicity to initiate a protective immunogenic response. Other strains with varying levels of attenuation are described.

Abstract: Liposome encapsulated antibiotic therapy has limited application against infectious organisms, which can sequester in non-phagocytic cells. Virulence factors of these infectious organisms, for example bacterial components, when used in the formulation of liposomes can enhance the effectiveness of liposomes as delivery systems in the treatment of disease. In this manner, multi-functional liposomes can be developed to treat target diseases. In addition to serving as antibiotic delivery systems, such liposomes also have an immunization effect. Thus, the liposomes can be used for both the prevention and treatment of diseases.

Abstract: V. cholerae vaccine strains which have a soft agar penetration-defective phenotype and methods for making such strains are described. Also described are methods for identifying new genes involved in V. cholerae motility and the cloning, identification, and sequencing of V. cholerae motB and fliC genes.