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: The present invention relates to attenuated guaB deletion mutants of a bacterium infecting veterinary species, more in particular Salmonella enterica, to their use and production. The present invention further relates to live attenuated vaccines based on such mutants for preventing bacterial infections, and more in particular Salmonellosis, in a veterinary species, more in particular poultry.

Abstract: This invention relates to recombinant bacterial outer membrane proteins comprising one or more LB1(f) peptides from surface-exposed loop 3 of MOMP P5 of non-typeable H. influenzae. Polynucleotides encoding these recombinant proteins are also covered. The invention also relates to a method of isolating the recombinant proteins and a vaccine composition for use in the treatment of Haemophilus influenzae infection.

Abstract: The present invention relates to a hybrid bacterial toxin subunit, to a hybrid bipartite bacterial toxin and to nucleic acid molecules comprising a nucleotide sequence encoding such bacterial toxins. Furthermore, the invention relates to vaccines comprising bacterial toxins and to their use in vaccines. Finally, the invention relates to methods for the preparation of such vaccines and to the use of such bacterial toxins for the manufacture of such vaccines.

Abstract: The invention belongs to the field of animal health and in particular the causative agent of a new bacterial poultry disease, Gallibacterium. The invention provides said Gallibacterium bacteria, vaccine comprising inactivated Gallibacterium, and a method of immunizing to prevent disease in poultry.

Abstract: A novel polyvalent attenuated live bacterial vaccine for preventing and curing vibriosis of cultivated fish is provided. The vaccine mainly comprises attenuated deletion strain of Vibrio anguillarum without marker gene, which has significant low toxicity, but remains immunogenicity against wild type strain of V. anguillarum, as compared with wild type strain MVM425. Moreover, the vaccine strain has excellent cross immunoprotection against Vibrio alginolyticus. The attenuated live vaccine made from the vaccine strain is effective to prevent and cure vibriosis of fish resulted from wild type strain of V. anguillarum and V. alginolyticus.

Abstract: Attenuated Listeria bacteria are provided. The subject bacteria are characterized by having a mutation in a gene chosen from the IpIA gene and the hly 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: The present invention includes compositions, methods and kits for inducing an immune response to a tumor and for treating cancer with a Listeria vaccine strain expressing an antigen fused to a truncated LLO protein.

Abstract: The present invention relates to a combination vaccine for the protection of poultry against Ornithobacterium rhinotracheale, to the use of a live over-attenuated Ornithobacterium rhinotracheale strain and a live attenuated poultry virus for the manufacturing of such a combination vaccine, to methods for the preparation of said combination vaccine and to vaccination kits for the immunization of poultry against Ornithobacterium rhinotracheale.

Abstract: The present invention relates to an immunogenic composition. More particularly, the present invention is a composition directed to eliciting an immune response to at least one binding site of Cyclophilin A on the HIV capsid protein. (SEQ ID NOS: 2, 4, and 6) The present invention contemplates three categories of embodiments: protein or protein fragments (SEQ ID NOS: 2, 4, and 6), messenger RNA, or DNA/RNA. DNA/RNA compositions (SEQ ID NOS 1, 3, 5, 7, 9, and 11) may be either naked or recombinant. The present invention further contemplates use with a variety of immune stimulants.

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 derived 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.

Abstract: Recombinant immunogenic compositions, and methods for the manufacture and use, are provided for the prevention and treatment of intracellular pathogen diseases in humans and animals. The recombinant immunogenic compositions express high levels of recombinant proteins in vectors that do not harbor an antibiotic resistance marker (“unmarked”).

Abstract: A method for producing theraputic vaccine which consist of NMDA-NRI subunit expressed in insect cells to produce recombinant protein which was encapsulated in PLGA or poly(lactide-co-glycolic acid) microparticles by solvent exchange and used for oral immunization. Excitotoxicity (i.e., a process in which an excessive amount of extracellular glutamate overexcites glutamate receptors and harms neurons) is the common cause involved in a number of neurodegenerative disorders such as Alzheimer, Parkinson, Huntington, Amyloid lateral sclerosis(ALS) and neurological conditions such as stroke, traumatic brain injury, Epilepsy. Thus the experimental model for stroke has been developed for the study of powerful N-methyl-d-aspartic acid (NMDA) NRI subunits, their protective and therapeutic potential for treatment of the neurodegenerative disorder Alzheimer's in animals and its practicability for therapy in humans.

Abstract: Polypeptides comprising non-typeable Haemophilus influenzae (NTHi) amino acid sequences. Over 2500 specific NTHi proteins are disclosed. The invention also provides related polypeptides, nucleic acids, antibodies and methods. These can all be used in medicine for treating or preventing disease and/or infection caused by H. influenzae, such as otitis media.

Abstract: Site-specific Listeria integration vectors and methods for their use are provided. The subject vectors include a bacteriophage integrase gene and a bacteriophage attachment site, where in many embodiments the bacteriophage that is the source of these elements is a listeriophage. In certain embodiments, the subject vectors further include a multiple cloning site, where the multiple cloning site may further include a polypeptide coding sequence, e.g., for a heterologous antigen. The subject vectors and methods find use in a variety of different applications, including the study of Listeria species and the preparation of Listeria vaccines.

Abstract: Process for extracting and purifying the recombinant Placental Growth Factor (PLGF) expressed in inducible prokaryotic expression systems comprising the following steps: I) fermentation of the bacterial cells, II) extraction and purification of the inclusion bodies, III) renaturation of the expressed protein, IV) ion-exchange chromatography, V) reverse-phase chromatography.

Abstract: Fish are immunized by a mass vaccination method, such as by immersion in water containing an attenuated strain of a pathogenic bacterium that does not effectively cause disease in fish when the non-attenuated pathogenic bacterium is exposed to the fish by immersion. An illustrative example of the method is for immunizing against coldwater disease caused by Flavobacterium psychrophilum, which may be attenuated by serial passage in media containing increasing amounts of an antibiotic, such as rifampicin.

Abstract: The present invention discloses attenuated Clostridium perfringens organisms that express a substantially nontoxic alpha-toxin. The expressed alpha-toxin is a deletion mutein that relative to the alpha-toxin of the mature alpha-toxin of Clostridium perfringens strain 13, is missing at least nine consecutive amino acid residues including His68. The present invention also discloses attenuated organisms that encode the muteins, as well as the use of such attenuated organisms as vaccines.

Abstract: The present invention relates to gram-negative bacterial mutants resistant to one or more stress conditions, including, but not limited to, CO2, acid pH, and high osmolarity. The present invention also relates more particularly to gram-negative bacterial mutants with reduced TNF-? induction having a mutation in one or more lipid biosynthesis genes, including, but not limited to msbB, that are rendered stress-resistant by a mutation in the zwf gene. The present invention provides compositions comprising one or more stress-resistant gram-negative bacterial mutants, preferably attenuated stress-resistant gram-negative bacterial mutants. In particular, the present invention relates to methods for prophylaxis or treatment of a virally induced disease in a subject comprising administering to said subject one or more stress-resistant gram-negative bacterial mutants, preferably attenuated stress-resistant gram-negative bacterial mutants.

Abstract: Oral immunogenic compositions imparting dual protection against enterotoxigenic labile toxin (LT)-expressing Escherichia coli (ETEC) and Vibrio cholerae based on the delivery 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 present invention provides a method for obtaining an immunogenic, non-haemolytic strain of Actinobacillus pleuropneumoniae which is modified, at least in a segment of the apxIA gene and optionally in a segment of the apxIIA gene that encodes a transmembrane domain of the Apx haemolytic and cytolytic exotoxins. It comprises also the strains, and the attenuated live vaccine porcine pleuorpneumonia obtained therewith.

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: The CAMP factor gene of Streptococcus uberis (S. uberis) is described, as well as the recombinant production of CAMP factor therefrom. Also disclosed are chimeric CAMP factor constructs, including CAMP factor epitopes from more than one bacterial species. The CAMP factors and chimeras including the same can be used in immunogenic compositions for the prevention and treatment of bacterial infections.

Abstract: The present invention includes compositions, methods and kits for enhancing the immunogenicity of an antigen via fusion to a Listerial protein. The present invention further encompasses Listeria vaccine strains for enhancing the immunogenicity of an antigen.

Abstract: The present invention provides methods and compositions for production of gram-negative bacterial mutants that are defective in intestinal colonization capacity and sensitive to infection by bacteriophage P1. Thus the present invention provides immunogenic compositions for the prevention or attenuation of food- and water-borne illnesses associated with ingestion of bacteria such as enterohemorrhagic Escherichia coli.

Abstract: The invention provides BASB119 polypeptides and polynucleotides encoding BASB119 polypeptides and methods for producing such polypeptides by recombinant techniques. Also provided are diagnostic, prophylactic and therapeutic uses.

Abstract: A procedure for obtaining the expression of a membrane antigen of a pathogen against which an live oral vaccine development is desirable on the surface of a negative Gram bacteria to which virulence is attenuated, or another bacteria or other Gram negative or positive bacteria with probiotic features which are compatible with the proposed expression system and that can be used as a live oral vaccine, wherein a plasmid is constructed and obtained based on the structure of pET family plasmids, with tbpB gene incorporated under the control of T7 promoter or another equivalent one, with the addition of a metabolic marker in the plasmid vector, previously cloned with its own promoter, inactivating, at the same time, the antibiotic resistance. In addition, recombinant microorganism such as an attenuated vaccine strain against group B meningitis with immunizing and protective properties against infection by Neisseria meningitidis.

Abstract: Recombinant plasmids usable for the transfection of eukaryotic and prokaryotic cells are described; such plasmids have a length comprised between 7 and 12 kbases and comprise a sequence encoding the heavy chain of an immunoglobulin; in particular, they may be used: in a process of transfection of prokaryotic or eukaryotic cells (ex vivo) which can be inoculated into higher organisms in order to induce a prophylactic or therapeutic immune response; in a protocol of direct inoculation (in vivo) in higher organisms in genic immunization methodologies with the aim of evoking prophylactic or therapeutic immune responses.

Abstract: The present invention provides recombinant polypeptides comprising an N-terminal fragment of an ActA protein or LLO protein fused to an antigen or a fragment thereof, nucleotides encoding same, recombinant vectors comprising same, and immunogenic and therapeutic methods utilizing same.

Abstract: The present invention relates to the discovery of a toxin-antitoxin system in opportunistic human pathogen Pseudomonas aeruginosa and to the applications of this discovery including the stabilization of plasmids useful in the field of recombinant DNA technology for production of genes and their products. The Phd-like (prevent host death) antitoxin protein and ParE-like toxin protein of the invention are shown in FIGS. 1, 2 and 15.

Abstract: The present invention concerns the use of methods and compositions to prophylactically or therapeutically vaccinate a subject against a pathogen or disease. Embodiments of the invention include the production of an attenuated bacterium from the family Enterobacteriaceae with a non-functional lipoprotein for use as a vaccine or as a vaccine vector for delivering antigens to a subject to be vaccinated. In certain embodiments, a bacterium of the Enterobacteriaceae family lacking a wild type LP, for example Salmonella typhimurium lacking a wild type LP, may be produced and used as a vaccine or vaccine vector.

Abstract: Vaccines and methods for making and using the same. An example vaccine may be a vaccine against enterotoxigenic Escherichia coli. The vaccine may include an Escherichia coli strain. The Escherichia coli strain may produce K88 fimbria and a fusion protein including a mutant LT enterotoxin linked with a STb enterotoxin. An example method for producing a vaccine for porcine post-weaning diarrhea may include providing a first strain of Escherichia coli. The strain may include the eltAB gene and the estB gene. The method may also include amplifying the eltAB gene, mutating the eltAB gene, generating a genetic fusion of the mutant eltAB gene with the estB gene, and transforming a second strain of Escherichia coli with the genetic fusion.

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: The present invention relates, e.g., to a Lactobacillus bacterium, which (1) expresses a recombinant polypeptide containing a lipoprotein signal sequence from the OspA protein of Borrelia burgdorferi, or an active variant of the leader sequence, operably linked to one or more heterologous polypeptide(s) of interest and/or (2) which comprises an expressible polynucleotide encoding a recombinant polypeptide, wherein the polynucleotide encodes a lipoprotein signal from the OspA protein of Borrelia burgdorferi, or an active variant thereof, which is operably linked to one or more heterologous polypeptide(s) of interest. In one embodiment, the heterologous polypeptide is from Yersinia pestis, the etiologic agent of plague. In another embodiment, the heterologous polypeptide is from Borrelia burgdorferi, the etiologic agent of Lyme disease.

Abstract: A recombinant BCG vaccine being transformed with an expression vector that has a polynucleotide encoding a foreign antigenic protein, wherein the polynucleotide is a modified one in which the third position of each codon is substituted with G or C without a change of an amino acid. This recombinant BCG vaccine has an excellent expression rate of antigenic protein and, as a result, capable of inducing a sufficient immune response against target infectious disease, cancer, or the like at the same dose as that of the typical BCG vaccine.

Abstract: The present invention relates to recombinant lipidated PsaA proteins and recombinant constructs from which such lipidated PsaA proteins may be expressed. The invention relates further to lipidated PsaA proteins in which lipidation is effected by the use of a heterologous leader sequence derived from the ospA gene of Borrelia burgdorferi, which leader sequence is joined in translational reading frame with the psaA structural gene. The invention also provides methods of preparation of lipidated PsaA proteins and use of such proteins in immunological compositions. Also provided are vaccines comprising immunogenic lipidated PsaA proteins and methods of use of such vaccines in the prevention and treatment of S. pneumoniae infection.

Abstract: A vaccine for the prevention of anthrax, including a live, attenuated Salmonella and at least one nucleotide sequence encoding anthrax protective antigen (PA) or a fragment thereof and a nonlethal mutated form of anthrax lethal factor (LF) or a fragment thereof. In another implementation, the vaccine is constituted for the prevention of anthrax and at least one additional pathogen, as including a live, attenuated Salmonella and at least one nucleotide sequence encoding at least a fragment of a nonlethal mutated form of anthrax lethal factor (LF) and at least one nucleotide sequence encoding at least a fragment of an antigen of an additional pathogen. Vaccines of such types can be administered to stimulate antibody response in a subject, whereby the antibody response confers immunity to the subject.

Abstract: Recombinant Mycobacterium strains with improved vaccinal properties for use as vaccinating agents are provided. The parent strains of the recombinant Mycobacterium strains are selected for their potent immunogenicity. The Mycobacterium strains do not display antibiotic resistance, and do not exhibit horizontal transfer to gram-negative bacteria.

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 list. Bacillus species are sporeformers and therefore are highly stable and can be fed to swine.

Abstract: A live, attenuated bacterium of the genus Escherichia, Yersinia or Salmonella, that does not have a functional tRNA5leu, and vaccines comprising the live, attenuated bacterium.

Abstract: Mycobacteria such as M. tuberculosis and M. leprae are considered to be prototypical intracellular bacilli that have evolved strategies to enable growth in the intracellular phagosomes of the host cell. By contrast, we show that lysosomes rapidly fuse with the virulent M. tuberculosis and M. leprae— containing phagosomes of human monocyte-derived dendritic cells and macrophages. After 2 days, M. tuberculosis progressively translocate from phagolysosomes into the cytosol where they replicate. Cytosolic entry is also observed for M. leprae but not for the vaccine strain, M. bovis BCG, or killed mycobacteria, and is dependent upon secretion of the mycobacterial gene products CFP-IO and ESAT-6 of the RDI region. The present invention further provides means and methods for using these findings in therapeutic and immunogenic compositions.

Abstract: The invention concerns Mycobacterium strains whereof the erp gene is modified and a vaccine composition containing same. The modification of the erp gene decreases the virulence and the persistence of the Mycobacterium strains.

Abstract: A mutated Bordetella strain comprising at least a mutated ptx gene, a deleted or mutated dnt gene and a heterologous ampG gene is provided. The attenuated mutated Bordetella strain can be used in an immunogenic composition or a vaccine for the treatment or prevention of a Bordetella infection. Use of the attenuated Bordetella strain for the manufacture of a vaccine or immunogenic composition, as well as methods for protecting mammals against infection by Bordetella are also provided.

Abstract: The present invention relates to a microorganism, preferably a bacterial strain, preferably a non-pathogenic strain, preferably a non-invasive strain, preferably a food grade strain, preferably a gram-positive bacterial strain, delivering a trefoil peptide in vivo. Preferably the trefoil peptide is TFF1. The present invention further relates to a method for the delivery of trefoil peptide to the gastro-intestinal tract comprising the administration of such a bacterial strain. The present invention also relates to a pharmaceutical composition comprising a trefoil peptide delivering bacterium as well as methods of treatment of acute gastro-intestinal inflammatory diseases comprising administration of transformed bacterial strains, particularly for treating acute colitis, including but not limited to acute flare-ups of Crohn's disease and ulcerative colitis in humans, as well as for treating gastro-intestinal disorders of a similar nature in other animal species.

Abstract: The present invention includes compositions, methods and kits for enhancing the immunogenicity of an antigen via fusion to a Listerial protein. The present invention further encompasses Listeria vaccine strains for enhancing the immunogenicity of an antigen.

Abstract: Helicobacter based preparations comprising a pharmacologically active molecule of interest are disclosed, as well as methods of preparing and using said preparations. In particular, Helicobacter pylori vectors, vector plasmids and recombinant cells that include a sequence encoding a pharmacologically active molecule of interest useful in therapeutic treatments and/or vaccination against disease are provided. Delivery of the pharamacologically active molecules is provided at the mucosal surface, such as the gastric mucosa or nasal membranes, to provide effective and continuous delivery of a pharmacologically active agent.

Abstract: The present invention is drawn to an immunogenic composition comprising OspC polypeptides from Lyme Disease causing Borrelia. In one embodiment, the immunogenic composition of the present invention comprises at least one OspC polypeptide or immunogenic fragment thereof from each of Borrelia burgdorferi OspC families A, B, I and K. In another embodiment, the immunogenic composition of the present invention comprises at least one OspC polypeptide or immunogenic fragment thereof from each of Borrelia afzelii OspC families A and B.

Abstract: A process was developed for expressing antimicrobial peptides in a recombinant host cell that eliminates host cell toxicity and antimicrobial peptide degradation, as well as providing a process for rapid purification. Fusion proteins comprising a periplasmic targeting signal, cleavage site, and antimicrobial peptides provide the basis for this process which produces antimicrobial peptides that may be used in antimicrobial compositions and articles.

Abstract: A scan of F. tularensis genome for homology to a regulatory protein that controls virulence identified gene FTL0552. A knock out mutation in FTL0552 was created using reverse transcriptase PCR and the construct inserted into F. tularensis. This mutant was defective for survival in macrophages and found avirulent in in vivo testing, where the mutant exhibited reduced levels of pro-inflammatory cytokine production, reduced evidence of histopathology in affected tissues, reduced systemic infection, and rapid clearance of the bacterium. In vivo challenge studies with the FTL0552 mutant using the virulent F. tularensis subsp. tularensis SchuS4 strain show an immune response is induced, and protection afforded, after preexposure to the FTL0552 mutant. Microarray studies revealed 148 genes regulated by FTL0552, including genes located within the FPI that are essential for intracellular survival.

Abstract: This invention provides recombinant polypeptides comprising a fragment of a High Molecular Weight Melanoma-Associated Antigen (HMW-MAA), recombinant Listeria strains comprising same, and methods of inducing an anti-HMW-MAA and anti HER-2/neu immune response thus treating and impeding the growth of tumors, comprising administering same.