Abstract: Provided herein are recombinant Listeria strains expressing a tumor-specific antigenic polypeptide and, optionally, an angiogenic polypeptide wherein a nucleic acid molecule encoding at least one of the polypeptides is operably integrated into the Listeria genome in an open reading frame with a nucleic acid sequence encoding a PEST-containing polypeptide, methods of preparing same, and methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering same.

Abstract: The present invention relates to the induction of tolerance to antigens, by mucosal, preferably oral delivery of the antigen in combination with an immunomodulating compound producing micro-organism. More specifically, the invention relates to the induction of Foxp3+ and/or IL-10 and/or TGF-? producing regulatory T-cells, capable of suppressing undesired immune responses toward an antigen, by oral delivery of said antigen in combination with an immunosuppressing cytokine secreting micro-organism.

Abstract: The present invention relates to the induction of tolerance to antigens, by mucosal, preferably oral delivery of the antigen in combination with an immunomodulating compound producing micro-organism. More specifically, the invention relates to the induction of Foxp3+ and/or IL-10 and/or TGF-? producing regulatory T-cells, capable of suppressing undesired immune responses toward an antigen, by oral delivery of said antigen in combination with an immunosuppressing cytokine secreting micro-organism.

Abstract: Provided herein are recombinant Listeria strains expressing a tumor-specific antigenic polypeptide and, optionally, an angiogenic polypeptide wherein a nucleic acid molecule encoding at least one of the polypeptides is operably integrated into the Listeria genome in an open reading frame with a nucleic acid sequence encoding a PEST-containing polypeptide, methods of preparing same, and methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering same.

Abstract: The invention provides live, attenuated enterohemorrhagic Escherichia coli (EHEC) bacteria in which the Shiga toxin coding sequences are deleted to abolish Shiga toxin production and one or more of the nucleotide sequences for the bacterial adhesin protein intimin, the locus of enterocyte effacement encoded regulator, and the translocated intimin receptor are mutated to inactivate the activity of the encoded protein(s). This live, attenuated E. coli bacteria is used in a vaccine for reducing or inhibiting carriage and shedding of EHEC in cattle.

Abstract: The present invention is directed to heat shock proteins from Mycobacterium leprae as well as their encoding polynucleotides and vectors and host cells containing these polynucleotides. These heat shock proteins and their encoding polynucleotides are useful in detection of Mycobacterium leprae. In addition, the heat shock protein can be used as an adjuvant in a pharmaceutical composition containing an antigen to induce or enhance the immune response against the antigen. Further, the heat shock protein may be used to treat atopic conditions or as a vaccine against Mycobacterium leprae. Alternatively, the heat shock protein can be used to form a fusion protein with an antigen to induce or enhance the immune response against the antigen.

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

Abstract: Disclosed is an oral delivery system that overcomes major barriers encountered in the gastrointestinal tract, particularly rapid proteolytic degradation and low intestinal permeability. Provided is a method for oral delivery of an engineered microorganism to a mammal where the microorganism produces a macromolecule having a desired bioavailability outcome.

Abstract: The present invention relates to combination vaccines and/or the combined use of immunogenic compositions for the treatment and/or prophylaxis of cattle against microbiological infections, wherein the infections are caused by M. bovis and at least one further cattle relevant pathogen. The combination vaccine as described herein comprises at least one M. bovis antigen, preferably the attenuated, avirulent M. bovis as provided herewith and one or more further immunologically active components effective for the treatment and/or prophylaxis of infections caused by a further pathogen of cattle.

Abstract: The present invention provides methods and compositions for treating or preventing allergic responses, particularly anaphylactic allergic responses, in subjects who are allergic to allergens or susceptible to allergies. Methods of the present invention utilize administration of microorganisms to subjects, where the microorganisms produce allergens and protect the subjects from exposure to the allergens until phagocytosed by antigen-presenting cells. Particularly preferred microorganisms are gram-negative bacteria, gram-positive bacteria, and yeast. Particularly preferred allergens are proteins found in foods, venoms, drugs and latex that elicit allergic reactions and anaphylactic allergic reactions in individuals who are allergic to the proteins or are susceptible to allergies to the proteins. The proteins may also be modified to reduce the ability of the proteins to bind and crosslink IgE antibodies and thereby reduce the risk of eliciting anaphylaxis without affecting T-cell mediated Th1-type immunity.

Abstract: The present invention relates to a gram positive bacterium, preferably a lactic acid bacterium (LAB) or Bifidobacterium, with increased stress resistance and/or improved manufacturing, processing and/or storage characteristics. In particular, the invention relates to a gram positive bacterium which accumulate intracellular trehalose. The gram positive bacterium according to the invention lack trehalose 6-phosphate phosphorylase (TrePP) activity. The gram positive bacterium may further lack cellobiose-specific PTS system IIC component (ptcC) activity. The gram positive bacterium may further overexpress trehalose transporters. The invention further relates to compositions comprising such gram positive bacterium as well as methods and uses thereof.

Abstract: This invention provides compositions and methods for treating and vaccinating against a Her2/neu antigen-expressing tumor and inducing an immune response against dominant in a human subject.

Abstract: The present invention relates to compositions and methods for disease treatment and prevention through administration of a live attenuated composition. In particular, the present invention provides compositions and methods for the treatment and prevention of urinary tract infection by administration of a live attenuated compositions lacking O-antigen ligase activity.

Abstract: Recombinant vectors comprising the cell entry region of the Shigella ox EIEC invasion plasmid are provided, as well as, Shigella or EIEC strains comprising the recombinant vectors. The vectors provide an improved platform for developing attenuated vaccine strains of Shigella or EiEC and for delivering other foreign proteins of interest. The recombinant vectors and bacterial strains comprising the same may be used in methods of inducing an immune response.

Abstract: A recombinant bacterial cell strain is disclosed. It comprises: a) a first vector comprising a fusion transgene encoding Ag85B-CFP10 fusion protein, the fusion transgene being operably linked to a promoter effective for expression of the Ag85B-CFP10 fusion protein; and b) a second vector comprising a transgene encoding interleukin-12 (IL-12), the transgene being operably linked to a promoter effective for expression of the IL-12 protein. A method of inhibiting intracellular growth of Mycobacterium in a subject is also disclosed.

Abstract: The present invention relates to novel Salmonella mutants, to a process for producing the same and to vaccines containing the same, wherein said Salmonella mutants are characterized in that they are not responsive to stress-related recrudescence. It is accordingly an object of the present invention to provide the use of said Salmonella mutants in the vaccination of animals, in particular mammals and birds, more in particular pigs, poultry and cattle.

Abstract: The invention relates to Salmonella typhi Ty21a comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2 and species homologs thereof; b) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2, and species homologs thereof; and c) DNA encoding a O antigen biosynthesis gene product that hybridizes under moderately stringent conditions to the DNA of (a) or (b); and related sequences, compositions of matter, vaccines, methods of using, and methods of making.

Abstract: Particular aspects provide efficient allelic exchange methods to generate directed mutations within genes of slow-growing stains of mycobacteria (e.g., Mycobacterium avium subsp. paratuberculosis (Map), Map 10 or GFP-expressing Map K-10) using a phage-delivery system, and demonstrate high efficiency allelic exchange. Additional exemplary aspects provide non-naturally occurring slow-growing strains of mycobacteria (e.g., Map, M. bovis, M. tuberculosis) having at least one gene deletion (e.g., pknG, relA, lsr2, panC, panD, proC, trpD, sapM (MAP3432), lysA_1, leuD, and leuC, and deletion mutants at the orthologous loci of two known virulence genes in pathogenic mycobacteria (relA and pknG) and one gene related to colony morphology and biofilm formation in fast growing mycobacteria (lsr2) were made. Further aspects provide novel vaccines comprising such deletion mutants, or portions thereof, and methods for making said vaccines. Yet further aspects provide methods for protecting a mammal from virulent Map, M.

Abstract: This invention provides methods and compositions for using Listeria monocytogenes as an adjuvant for enhancing immune responses in a subject.

Abstract: Mutant Listeria bacteria that modulate interferon-B production are provided. The subject bacteria are characterized by having a mutation in a gene chosen from a TetR gene, a LadR gene, a VirR gene, a MarR gene a MdrL gene, a MdrT gene and a MdrM gene. The subject bacteria find use in a variety of applications, where representative applications of interest include, but are not limited to: (a) use of the subject bacteria as adjuvants; (b) use of the subject bacteria as delivery vectors for introducing macromolecules into a cell; (c) use of the subject bacteria as vaccines for eliciting or boosting a cellular immune response; etc.

Abstract: Schistosomiasis mansoni is caused by flukes called Schistosoma(es) that enters the human body through the skin in Schistosoma infested waters. The Schistosomes travel from the skin into human blood vessels where they mate, produce antigen containing eggs that travel from the blood vessels into the small intestines, where they are released in the human feces. Male and female Schistosome mates in human blood vessels, male Schistosomes secrete a protein called TGR ? protein to the Trk receptor sites on the females Schistosomes membranes. The process stimulates the formation of chemical SmInAct in female Schistosomes, a chemical necessary for the female Schistosomes to produce eggs. This novel technique describes new methods to inhibit Trk receptor sites on female Schistosome membranes using Trk inhibitor agent to prevent TGR ? proteins from binding to the Trk receptor sites. Thus, preventing SmInAct from being created in female Schistosomes, preventing production of eggs and Schistosomiasis.

Abstract: The present invention relates to DNA sequences encoding Vmp-like polypeptides of pathogenic Borrelia, the use of the DNA sequences in recombinant vectors to express polypeptides, the encoded amino acid sequences, application of the DNA and amino acid sequences to the production of polypeptides as antigens for immunoprophylaxis, immunotherapy, and immunodiagnosis. Also disclosed are the use of the nucleic acid sequences as probes or primers for the detection of organisms causing Lyme disease, relapsing fever, or related disorders, and kits designed to facilitate methods of using the described polypeptides, DNA segments and antibodies.

Abstract: Bacillus strains that inhibit pathogenic swine E. coli and/or improve performance are provided. Inhibition of pathogenic swine E. coli decreases E. coli disease. At least one strain enhanced swine performance by improving average daily gain, feed efficiency, and feed intake. Preferred Bacillus strains are of species that are included on the GRAS, i.e., generally recognized as safe, list. Bacillus species are sporeformers and therefore are highly stable and can be fed to swine.

Abstract: The invention relates to Salmonella typhi Ty21a comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2 and species homologs thereof; b) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2, and species homologs thereof; and c) DNA encoding a O antigen biosynthesis gene product that hybridizes under moderately stringent conditions to the DNA of (a) or (b); and related sequences, compositions of matter, vaccines, methods of using, and methods of making.

Abstract: Provided herein are Salmonella enteritidis 13A strains and compositions comprising these strains. Also provided are methods of enhancing an immune response against Influenza A and methods of reducing morbidity associated with an Influenza A infection. Methods of enhancing an immune response to a vaccine vector by expressing a polypeptide of CD154 capable of binding CD40 are also disclosed. Methods of developing a bacterial vaccine vector are disclosed. Methods of generating scarless site-specific mutations in a bacterium are also disclosed.

Abstract: The present invention relates to a gene expression and eradication system for Helicobacter pylori (H. pylori). In particular, the present invention relates to a genetic construct comprising, in the 5?-3? direction: (a) a promoter sequence and (b) a DNA sequence of interest, wherein the promoter sequence comprises a polynucleotide sequence capable of regulating expression of the DNA sequence of interest in Helicobacter pylori and wherein said promoter sequence is modified to comprise a tetracycline (tet) operator sequence.

Abstract: Bacterial delivery systems with improved transgene expression are provided. The recombinant bacterial delivery systems deliver transgenes of interest and suppressors of the eukaryotic Type I interferon response to eukaryotic cells. Suppression of the eukaryotic Type I interferon response allows improved expression of the encoded transgene.

Abstract: Attenuated microorganisms expressing Clostridium difficile antigen(s), and methods of using the same for vaccination of patients are disclosed The invention provides an attenuated microorganism expressing an immunogenic portion of a C difficile Toxin A C-terminal repeat region and/or a C difficile Toxin B C-terminal repeat region The microorganism is an attenuated Salmonella comprising an integrated gene expression cassette that directs the expression of the immunogenic peptide from an in vivo inducible promoter.

Abstract: A recombinant avian infectious coryza vaccine and a process for preparing the same are provided. A process for preparing a recombinant avian infectious coryza vaccine which comprises step of constructing E. coli that may produce as an inclusion body a fusion peptide consisting of peptides derived from outer-membrane protein of Avibacterium paragarinarum serotype A and serotype C, step of culturing said E. coli and collecting and purifying inclusion body from culture, and step of preparing a preparation comprising said purified inclusion body, and an avian infectious coryza vaccine comprising as an active ingredient the fusion peptide. A linker sequence may be inserted between the respective peptides comprising the fusion peptide. For the peptide derived from the serotypes A and C, an amino acid sequence region of Region 2 or its vicinity responsible for protection from infection may be used.

Abstract: Gram-negative bacteria, and compositions containing the bacteria, resistant to one or more stress conditions, including, but not limited to, CO2, acid pH, and high osmolarity, having reduced TNF-?induction having a mutation in one or more lipid biosynthesis genes, e.g., msbB, rendered stress-resistant by a mutation in the zwf gene are provided. Methods for prophylaxis or treatment of a virally induced disease in a subject comprising administering preferably attenuated stress-resistant gram-negative bacterial mutants. and for prophylaxis or treatment of a virally induced disease in a subject comprising administering one or more stress-resistant gram-negative bacterial mutants as vectors for the delivery of one or more therapeutic molecules are provided.

Abstract: Exemplary embodiments disclosed herein include a microorganism that produces, secretes and injects recombinant antibodies into eukaryote cells said the described microorganisms can be used to prepare pharmaceutical compositions for the treatment of human or veterinary diseases.

Abstract: The present invention relates to a mutated Francisella bacterium, wherein the ggt gene is silenced or deleted; pharmaceutical compositions comprising the same, in particular, vaccine compositions, and use of the bacterium and compositions for treatment and/or prophylaxis, and in particular, the treatment or prophylaxis of tularemia.

Abstract: Provided herein are prime-boost regimens and materials used therein. The prime-boost regimens enhance the immune response to a target antigen. The vaccines used for boost are comprised of recombinant attenuated metabolically active Listeria that encodes an expressible antigen that is cross-reactive with the target antigen. In some examples, the immune response is a cellular immune response.

Abstract: A composition comprising intact killed bacterial cells that contain a therapeutic nucleic acid, a drug or a functional nucleic acid is useful for targeted delivery to mammalian cells. The targeted delivery optionally employs bispecific ligands, comprising a first arm that carries specificity for a killed bacterial cell surface structure and a second arm that carries specificity for a mammalian cell surface receptor, to target killed bacterial cells to specific mammalian cells and to cause endocytosis of the killed bacterial cells by the mammalian cells. Alternatively, the delivery method exploits the natural ability of phagocytic mammalian cells to engulf killed bacterial cells without the use of bispecific ligands.

Abstract: This document provides live non-pathogenic M. bovis bacteria and compositions containing live non-pathogenic M. bovis bacteria. This document also provides methods of using live non-pathogenic M. bovis bacteria to immunize cattle against infectious diseases (e.g., diseases caused by M. bovis bacteria). In addition, methods and materials that can be used to generate live non-pathogenic M. bovis bacteria are provided.

Abstract: The present invention relates to the field of veterinary parasitology, especially of canine Babesiosis. In particular the invention relates to a polypeptide being a novel canine Babesia antigen (CBA), or fragments thereof, and to compositions comprising this antigen, to nucleic acids encoding the antigen, antibodies against the antigen, and medical uses of this antigen, fragments, antibodies, or encoding nucleic acids. In particular the invention relates to the use of such components in vaccines against canine Babesiosis.

Abstract: The present invention provides methods and compositions for treating or preventing allergic responses, particularly anaphylactic allergic responses, in subjects who are allergic to allergens or susceptible to allergies. Methods of the present invention utilize administration of microorganisms to subjects, where the microorganisms produce allergens and protect the subjects from exposure to the allergens until phagocytosed by antigen-presenting cells. Particularly preferred microorganisms are gram-negative bacteria, gram-positive bacteria, and yeast. Particularly preferred allergens are proteins found in foods, venoms, drugs and latex that elicit allergic reactions and anaphylactic allergic reactions in individuals who are allergic to the proteins or are susceptible to allergies to the proteins. The proteins may also be modified to reduce the ability of the proteins to bind and crosslink IgE antibodies and thereby reduce the risk of eliciting anaphylaxis without affecting T-cell mediated Th1-type immunity.

Abstract: The present disclosure generally relates to genetic engineering of bacteria. More particularly, the present disclosure relates to genetic engineering of Gram-negative bacteria expressing different species of lipid A on their surface. In one embodiment, the present disclosure provides for an engineered strain of E. coli according to Table 1. In another embodiment, the present disclosure provides for a lipopolysaccharide purified from an engineered strain of E. coli according to Table 1.

Abstract: The present invention relates to the treatment of autoimmune and allergic diseases by mucosal delivery by micro-organism, in particular Lactococcus lactis, of secreted immunodominant antigens.

Abstract: Bacterial delivery systems with improved transgene expression are provided. The recombinant bacterial delivery systems deliver transgenes of interest and suppressors of the eukaryotic Type I interferon response to eukaryotic cells. Suppression of the eukaryotic Type I interferon response allows improved expression of the encoded transgene.

Abstract: The present invention relates to a life attenuated Bordetella pertussis vaccine which is deficient for tracheal cytotoxin (TCT), pertussis toxin (PTX), and dermonecrotic toxin (DNT) for prophylaxis or treatment of an allergen-driven airway pathology.

Abstract: The present disclosure provides temperature sensitive essential nucleic acid molecules from a psychrophilic bacterium, proteins encoded by the nucleic acid molecules, as well as recombinant cells into which have been introduced such nucleic acid molecules. The disclosed recombinant cells containing one or more essential nucleic acid molecules from a psychrophilic bacterium are thereby made temperature sensitive, and can be administered to a mammal to induce an immune response in the mammal.

Abstract: The disclosure relates generally to an antigenic composition useful for immunization against tularemia. The disclosure is a method for producing a vaccine for preventing tularemia in humans and animals, a new vaccine against tularemia in humans and animals, and a new approach to producing vaccines against tularemia.

Abstract: The invention relates to compositions and methods for making and using recombinant bacteria that are capable of regulated attenuation and/or regulated expression of one or more antigens of interest.

Abstract: Combination peptides, polypeptides and proteins that elicit high titer neutralizing antibodies against cytomegalovirus (CMV) are provided. The combination peptides, polypeptides and proteins encompass epitopes located within the UL130 and UL131 components of the gH/gL/UL128-131 protein complex, in particular, epitopes located within amino acid residues 27-46 of UL130 and amino acid residues 90-106 of UL131. The combination peptides, polypeptides and proteins, and the nucleic acids encoding them, may be used in vaccines, and as diagnostic and research tools.

Abstract: The present invention relates to a recombinant bacterium expressing an antigen that is translocated to the cytosol of a host organism, and uses thereof. To this end, the present invention provides a recombinant bacterium comprising a nucleic acid encoding an antigen that is translocated to the cytosol of a host cell utilizing Type III secretion system. The recombinant bacterium is generally chosen from intracellular pathogens that reside in the phagosome and fail to induce rapid T cell activation. The translocated antigen may be a viral antigen, a bacterial antigen, or a tumour antigen. Methods of imparting immunity using the recombinant bacterium are also provided.

Abstract: There is provided an antigenic composition comprising (a) a first mycobacterial antigenic polypeptide or a first mycobacterial polynucleotide; and (b) a second mycobacterial antigenic polypeptide or a second mycobacterial polynucleotide; wherein: (i) said first mycobacterial antigenic polypeptide comprises a polypeptide sequence having at least 70% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 1 or 7, or a fragment thereof having at least 7 consecutive amino acids thereof; (ii) said first mycobacterial polynucleotide comprises a polynucleotide sequence encoding said first mycobacterial antigenic polypeptide; (iii) said second mycobacterial antigenic polypeptide comprises a polypeptide sequence having at least 70% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 5, or a fragment thereof having at least 7 consecutive amino acids thereof; and (iv) said second mycobacterial polynucleotide comprises a polynucleotide sequence encoding said second mycobacterial polypeptid

Abstract: The present invention provides methods and compositions for treating or preventing allergic responses, particularly anaphylactic allergic responses, in subjects who are allergic to allergens or susceptible to allergies. Methods of the present invention utilize administration of microorganisms to subjects, where the microorganisms produce allergens and protect the subjects from exposure to the allergens until phagocytosed by antigen-presenting cells. Particularly preferred microorganisms are gram-negative bacteria, gram-positive bacteria, and yeast. Particularly preferred allergens are proteins found in foods, venoms, drugs and latex that elicit allergic reactions and anaphylactic allergic reactions in individuals who are allergic to the proteins or are susceptible to allergies to the proteins. The proteins may also be modified to reduce the ability of the proteins to bind and crosslink IgE antibodies and thereby reduce the risk of eliciting anaphylaxis without affecting T-cell mediated Th1-type immunity.

Abstract: Immunogenic compositions imparting dual protection against enterotoxigenic labile toxin (LT)-expressing Escherichia coli (ETEC) and Vibrio cholerae based on the hyperexpression of recombinant cholera toxin B antigen by attenuated, live bacterial vectors derived from Vibrio cholerae are disclosed. The compositions exhibit dual immunogenicity and retain the ability to colonize gastrointestinal mucosa-associated lymphoid tissues.

Abstract: The invention relates to Streptococcus suis infection in pigs, vaccines directed against those infections and tests for diagnosing Streptococcus suis infections. The invention provides an isolated or recombinant nucleic acid encoding a capsular gene cluster of Streptococcus suis or a gene or gene fragment derivated thereof. The invention further provides a nucleic acid probe or primer allowing species or serotype-specific detection of Streptococcus suis. The invention also provides a Streptococcus suis antigen and vaccine derived thereof.