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 invention provides an attenuated Salmonella vaccine vector comprising one or more heterologous polynucleotides that encode immunogenic Chlamydial peptides. In one embodiment, the attenuated Salmonella vaccine vector comprises aroC and ssaV attenuating mutations. The heterologous polynucleotides encoding the immunogenic Chlamydial peptides can be under the control of an inducible promoter such as a Salmonella ssaG promoter. In one embodiment of the invention, the immunogenic Chlamydial peptide is a PmpG peptide, for instance, a CT110, CT84 or CT40 peptide.

Abstract: A DNA composition effective for inhibiting endothelial cell proliferation comprises a DNA construct operably encoding a vascular endothelial growth factor (VEGF) receptor polypeptide, which can be a full length VEGF receptor protein or an immunogenic fragment thereof. This invention provides DNA compositions that encode VEGF receptor-2 (KDR), VEGF receptor-1 (Flt-1), or Flk-1 (the murine homolog of KDR), as well as methods of using such a DNA composition to inhibit vascular endothelial cell proliferation in the tumor micro-environment. Angiogenesis inhibition and subsequent decrease in tumor growth and dissemination is achieved.

Abstract: Method for producing multiple modifications in the chromosome of Gram-negative bacteria and Salmonella strains which are deficient in c-di-GMP synthesis obtained by said method. The method can be used to make multiple modifications in the genome of Gram-negative bacteria, simply and efficiently, using the plasmids of the invention, which comprise a marker gene under the control of a constitutive promoter, a replication origin specific for Gram-negative bacteria, a gene which encodes a heat-sensitive protein essential for initiating replication of the plasmid, making the replication origin heat-sensitive, and a counter-selection gene.

Abstract: The present invention concerns methods and compositions for treating or preventing a bacterial infection, particularly infection by a Staphylococcus bacterium. The invention provides methods and compositions for stimulating an immune response against the bacteria. In certain embodiments, the methods and compositions involve an Eap, Emp and/or AdsA amino acid sequence, or an agent that binds and inhibits the same.

Abstract: Disclosed are Vibrio cholerae comprising a mutated transcriptional regulatory protein (ToxT) amino acid sequence, wherein the mutation results in a reduction in the expression of cholera toxin by the Vibrio cholerae. Also disclosed are Vibrio cholerae comprising a mutated transcriptional regulatory protein (ToxT) amino acid sequence, wherein the mutation results in an increase in transcription of the nucleic acid encoding the mutated ToxT. Vaccines comprising the aforementioned Vibrio cholerae are disclosed. Also disclosed are amino acid sequences that encode a mutated ToxT protein.

Abstract: Screening and diagnostic reagents, kits and methods for metastatic colorectal cancer or primary and/or metastatic stomach or esophageal cancer are disclosed. Vaccines compositions and methods of for treating and preventing metastatic colorectal cancer or primary and/or metastatic stomach or esophageal cancer are disclosed.

Abstract: This invention relates to the identification of prostate stem cell antigen (PSCA) as a target of clinically relevant antitumor immune responses. The invention provides vaccines comprising PSCA, or fragments thereof, which are useful in inducing antitumor immune responses, including PSCA specific CD8+ T cell responses. Methods of using the compositions to treat cancer are also provided. The invention further provides methods of identifying compounds useful in antitumor vaccines and methods of assessing the responses of patients to cancer immunotherapy.

Abstract: A method for identifying a microorganism having a reduced adaptation to a particular environment comprising the steps of: (1) providing a plurality of microorganisms each of which is independently mutated by the insertional inactivation of a gene with a nucleic acid comprising a unique marker sequence so that each mutant contains a different marker sequence, or clones of the said microorganism; (2) providing individually a stored sample of each mutant produced by step (1) and providing individually stored nucleic acid comprising the unique marker sequence from each individual mutant; (3) introducing a plurality of mutants produced by step (1) into the said particular environment and allowing those microorganisms which are able to do so to grow in the said environment; (4) retrieving microorganisms from the said environment or a selected part thereof and isolating the nucleic acid from the retrieved microorganisms; (5) comparing any marker sequences in the nucleic acid isolated in step (4) to the unique mar

Abstract: This invention is directed to methods for treating a central nervous system (CNS) tumor or cancer using live Listeria-based recombinant vaccines.

Abstract: Specific genetic deletion are identified in mycobacteria isolates, including variations in the M. tuberculosis genome sequence between isolates, and numerous deletion present in BCG as compared to M. tb. These deletions are used as markers to distinguish between pathogenic and avirulent strains, and as a marker for particular M. tb. isolates. Deletions specific to vaccine strains of BCG are useful in determining whether a positive tuberculin skin test is indicative of actual tuberculosis infection. The deleted sequences may be reintroduced into BCG to improve the efficacy of vaccination. Alternatively, the genetic sequence that corresponds to the deletion(s) are deleted from M. bovis or M. tuberculosis to attenuate the pathogenic bacteria.

Abstract: The present invention describes an immunogenic formulation to be used in mammals against the respiratory syncytial virus (RSV), consisting in the Calmette-Guérin bacillus (BCG) strain or other attenuated Mycobacterium strain that expresses heterologously at least one protein or immunogenic fragment of the RSV subtype A or RSV subtype B strains, originated from proteins NS1, NS2, N, P, M, SH, M2 (ORF1), M2 (ORF2), L, F or G. The genetic material that encodes for these proteins or immunogenic fragments is inserted into the BCG genome or extrachromosomally in one or several copies, which expression is regulated by endogenous or exogenous BCG promoters, either constitutive or inducible. The viral proteins or immunogenic fragments can be expressed by BCG as cytoplasmic-soluble, extracellularly-secreted or cell membrane-bound proteins. The preparation can further contain combinations of previously described formulations. The formulation can be stabilized by freeze-drying (conservation range from 4° C. and 25° C.

Abstract: Provided are recombinant mycobacteria expressing an HIV-1 antigen and a malarial antigen. Also provided are Mycobacterium smegmatis expressing an HIV-1 antigen. Further provided are vaccines capable of inducing an immune response in a mammal against HIV-1 and the malarial pathogen. Additionally provided are methods of inducing an immune response in a mammal against HIV-1 and a malarial pathogen. Also provided are methods of inducing an immune response in a mammal against HIV-1. The methods comprise infecting the mammal with any of the above-described mycobacteria.

Abstract: The invention provides strains of bacteria, especially enterotoxigenic E. coli, attenuated by mutations in the genes encoding enterotoxins (LT, ST, EAST1) and optionally further attenuated by deletion of additional chromosomal genes. In addition the invention provides strains of attenuated bacteria expressing immunogenic but non-toxic variants of one or more of these enterotoxins. These bacteria are useful as a vaccine against diarrhoeal disease.

Abstract: Safe and effective live vaccines against Aeromonas hydrophila of fish were created through the induction of rifampicin resistance in native Aeromonas hydrophila isolates; these including rifampicin-resistant mutants NRRL-B-50040 and NRRL-B-50041. Single immersion exposure of fish stimulated acquired immunity against virulent Aeromonas hydrophila infection.

Abstract: The present invention discloses novel proteins, e.g., antigens, from Piscirickettsia salmonis. The present invention further discloses nucleic acids that encode these proteins. The present invention also discloses the use of the proteins, e.g., antigens, and nucleic acids to prepare vaccines against salmonid rickettsial septicemia (SRS). The present invention further provides recombinant Yersinia ruckeri cells to be used to construct vaccines against SRS. The present invention also discloses vaccines that to can be used to protect fish from Piscirickettsia salmonis, as well as other pathogens. In addition, the present invention discloses methods of using the vaccines of the present invention to protect fish from SRS as well as from other pathogenic diseases.

Abstract: Described are Streptococcus suis infections in pigs, vaccines directed against those infections and tests for diagnosing S. suis infections. Provided is an isolated or recombinant nucleic acid encoding a capsular gene cluster of S. suis or a gene or gene fragment derived therefrom. Further provided is a nucleic acid probe or primer allowing species or serotype-specific detection of S. suis. Also provided is a Streptococcus suis antigen and vaccine derived therefrom.

Abstract: The present invention relates to compositions and fusion proteins containing at least two Mycobacterium sp. antigens, and nucleic acids encoding such compositions and fusion proteins. The compositions of the invention increase serological sensitivity of sera from individuals infected with tuberculosis, and methods for their use in the diagnosis, treatment, and prevention of tuberculosis infection.

Abstract: The present disclosure relates to T24 nucleic acid sequences, amino acid sequences, and antibodies. Methods for detecting and diagnosing Taenia solium infection in a subject using the T24 sequences and specific binding agents are also disclosed. The T24 sequences disclosed herein can be formulated into a pharmaceutical composition for administration to a subject. For example, the disclosed T24 polypeptides can also be administered to a subject to stimulate an immune response in the subject, thereby protecting the subject against T. solium infection.

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: This invention provides compositions and methods for treating and vaccinating against an Her2/neu antigen-expressing tumor and inducing an immune response against dominant and several sub-dominant epitopes of the antigen.

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: The present invention relates generally to the production, purification, and isolation of human growth hormone (hGH). More particularly, the invention relates to the production, purification, and isolation of substantially purified hGH comprising non-naturally encoded amino acids and hGH from recombinant host cells or culture medium including, for example, yeast, insect, mammalian and bacterial host cells. The process of the present invention is also useful for purification of hGH linked to polymers or other molecules.

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: Immunogenic compositions comprising recombinant intracellular pathogens that have been transformed to express recombinant immunogenic antigens of the same or other intracellular pathogens and immunostimulatory molecules are provided. Exemplary immunogenic compositions include, but are not limited to, recombinant BCG expressing Mycobacteria major extracellular proteins and immunostimulatory molecules.

Abstract: The present invention relates to the structural proteins of the causative agent of Pancreatic Disease in fish, nucleotide sequences encoding said proteins, vaccines comprising said proteins or nucleotide sequences and diagnostic kits comprising said proteins or nucleotide sequences.

Abstract: Disclosed and claimed are a mutant of a gram negative bacterium, wherein said bacterium has at least one mutation in a nucleotide sequence which codes for a polypeptide having an identity which is equal or more than 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% with an amino acid sequence coded by a nucleotide sequence selected from the group consisting of nucleotide sequences identified SEQ ID NO: 2, 6, 9, 12, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58, 61, 64, 67, 70, 75, 78, 81, 84, 87, 90, 93; said mutation resulting in attenuated virulence of the bacterium. Immunogenic compositions and vaccines containing such a mutant are also disclosed and claimed.

Abstract: The invention relates to a humanized nucleic acid construct from Bacillus anthracis protective antigen (PA) gene and method of modifying the gene. The humanized gene, and method of producing it, improves the structural fidelity of expressed protein product, when produced in mammalian host cells, to native, bacterially produced protein. The construct is useful in nucleic acid based vaccine formulations against B. anthracis.

Abstract: Provided are mycobacteria comprising a recombinant gene operably liked to a mammalian promoter that directs expression of the recombinant gene from a mammalian cell. Also provided are mammalian cells comprising the above mycobacteria. Additionally provided are mycobacterial plasmids capable of replication in a mycobacterium. Further provided are methods of expressing a recombinant gene in a mammalian cell.

Abstract: Methods for immunizing a subject to an antigen of an infectious agent, a tumor, or an allergen are provided, using vegetative cytoplasmic expression of the antigen or spore surface display of the antigen, and contacting the subject with a composition including a spore or a vegetative cell or both with or without an adjuvant. Also included are thermally-stable vaccine compositions using the method described above and kits including the compositions.

Abstract: A vaccine for treating or preventing the establishment of latent tuberculosis infections is provided. The vaccine comprises a recombinant mycobacterium that overexpresses the transcription factor DosR, at a level sufficient to induce production of the dosR regulon genes or proteins. A host to whom the vaccine is administered mounts an immune response to the dosR regulon proteins and is thus protected from the establishment, persistence or reactivation of latent tuberculosis.

Abstract: The present disclosure describes pathogenic bacteria that have been modified to be deficient in NiFe hydrogenase activity; compositions comprising such modified bacteria, and the use of such bacteria to protect animals from pathogenic enteric bacterial infections.

Abstract: An attenuated bacteria has been made by an insertion mutation in the iglC gene of Francisella asiatica, by allelic exchange. The attenuated strain proved to be an effective vaccine by providing protection against an infection of F. asiatica in tilapia, and is believed would at least partially immunize fish from other species of Francisella. The vaccine of the attenuated Francisella asiatica ?iglC mutant can also serve as vectors to present antigens from other pathogens to the fish, thereby serving as vaccines against other pathogens as well. In addition, a highly sensitive and specific assay that can be used for the specific identification of F. asiatica in fish has been developed.

Abstract: The present invention relates to a vaccine against porcine circovirus type 2 (PCV-)2 and a method for the manufacture of such a vaccine, for protecting piglets against PCV-2 infection. It has been found that a vaccine comprising at least 20 microgram/dose of ORF-2 protein of porcine circovirus type 2 (PCV-2 is capable of eliciting a protective immune response against PCV-2 (and thus against PMWS) even when they have a relatively high titer of MDA against PCV-2. A vaccine according to the invention may contain a recombinant ORF-2 protein, wherein said recombinant protein is preferably produced by way of expression from a baculovirus expression vector in insect cells, said baculovirus expression vector containing the PCV-2 ORF-2 gene sequence under control of a suitable promoter.

Abstract: Targeted disruption of the centrin gene leads to attenuation of growth in Leishmania. Preferred embodiments of the invention provide attenuated strains of Leishmania useful for the preparation of immunogenic preparations including vaccines against a disease caused by infection with a virulent Leishmania strain and as tools for the generation of immunological and diagnostic reagents. Other preferred embodiments provide related immunogenic compositions, methods of generating an immune response, methods for producing a vaccine, and methods of forming attenuated strains of Leishmania.

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 CD 154 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: A method for immunizing fish against pathogenic infection is disclosed. More particularly, this invention provides a method of immunizing fish against bacterial and viral infection which comprises immersing the fish in a solution comprised of an effective amount of dead or attenuated, whole-celled recombinant bacteria, the recombinant bacteria having a eukaryotic expression vector (plasmid) incorporated therein having DNA of interest encoding at least one protein antigen for each of the pathogens, the method characterized in that the protein antigen is produced by the fish.

Abstract: The present invention relates to live attenuated Salmonella cultures for use as vaccines. The Salmonella cultures of the present invention have a substantially reduced capacity to grow and replicate in the presence of bile. The reduced capacity for growth is due to a metabolic-drift mutation induced by exposure to a combination of nalidixic acid and rifampicin for a time and under conditions sufficient to induce the mutation.

Abstract: The present invention provides Listeria strains that express a heterologous antigen and a metabolic enzyme, and methods of generating same.

Abstract: Single-dose controlled-release immunogenic formulations, such as vaccines, based on bioerodible polyanhydride copolymer or homopolymer microparticles for the control of immune response mechanisms are provided. The copolymer or homopolymer microparticles degrade by surface-erosion from in vivo hydrolysis of anhydride linkages at the surface of the microparticle, which results in controlled release of immunogen(s) to a patient.

Abstract: Introduction of immunomodulatory T3SS polypeptides (IT3SSP's) into cells stimulates a response mediated by NLRC4 intracellularly. Introduction of said IT3SSP into the cells of a subject evoke an innate immune response in the subject.

Abstract: The present invention provides Listeria strains that express a heterologous antigen and a metabolic enzyme, and methods of generating same.

Abstract: The present invention relates to the treatment of prostate cancer. Methods and compositions comprising recombinant BCG are provided for eliciting potent immune responses against prostate specific antigens that are effective for treatment of prostate cancer and metastatic disease.

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: The present invention provides Listeria strains that express a heterologous antigen and a metabolic enzyme, and methods of generating same.

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 invention concerns a methylated immunogenic recombinant peptide sequence comprising mycobacterial heparin-binding hemagglutinin. The invention also concerns chemical and enzymatic methods for preparing such a sequence, the sequence being previously produced in a non-methylated recombinant form then methylated by post-translational modification. The invention further concerns recombinant tools, vectors and host cells for implementing post-translational enzymatic methylation of the recombinant HBHA. The invention finally concerns immunogenic compositions comprising methylated, native or recombinant HBHA, such compositions being useful for preparing vaccines against mycobacterial infections.

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: Compositions and methods for protecting a susceptible host against an infection of Shigella sonnei are disclosed. Such compositions and methods are useful for protecting the host against bacillary dysentery and shigellosis.

Abstract: This invention provides methods of treating and vaccinating against an antigen-expressing tumor and inducing an immune response against a sub-dominant epitope of antigen, comprising a fusion of an LLO fragment to the antigen or a recombinant Listeria strain expressing the antigen. The present invention also provides recombinant peptides comprising a listeriolysin (LLO) protein fragment fused to a Her-2 protein or fragment thereof, recombinant Listeria strains expressing a Her-2 protein, vaccines and immunogenic compositions comprising same, and methods of inducing an anti-Her-2 immune response and treating and vaccinating against a Her-2-expressing tumor, comprising same.