Abstract: The present invention relates to cell-surface-located polypeptides of Streptococcus pneumoniae and their use in immunisation against Streptococcal infection, in diagnosis of Streptococcus and in identification of compounds with anti-Streptococcus activity. In a further aspect, the invention relates to antibodies capable of recognising cell surface-located polypeptides of Streptococcus pneumoniae and uses thereof.

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 invention relates to recombinant lactobacillus, use of the same and a pharmaceutical composition including the same. The recombinant lactobacillus includes a heterologous nucleic acid sequence. The heterologous nucleic acid sequence encodes at least an immunogenic fragment of the mite allergens Der p 1, Der p 2, or Blo t 5, or an immunogenic homolog thereof. A respective fragment of Der p 1 includes at least 8% of the amino acid sequence of the mite allergen. A method of modulating the immune response to an allergen in a mammal as well as a pharmaceutical composition and a kit are also disclosed.

Abstract: This disclosure relates to a modified version of cyanovirin-N protein and a transformed Lactobacillus bacterium that is capable of recombinantly expressing this modified protein. Further disclosed are polynucleotide sequence encoding the modified cyanovirin-N protein, expression cassette that allows the expression of the modified protein, and method of make and use of the modified protein as well as the transformed Lactobacillus bacterium. In addition, this disclosure describes two novel promoters originated from L. jensenii, which are capable of directing a high level of gene expression in Lactobacillus bacteria. Also described are an expression cassette comprising one of the novel promoters, a genetically modified Lactobacillus bacterium containing the expression cassette, a method for recombinant gene expression in Lactobacillus bacteria using the novel promoters, and a method for delivery of proteins with desired biological activity to a mucosal surface in a human.

Abstract: The present invention provides an adjuvant, which includes at least one single strand deoxynucleotide containing a CpG dinucleotide. The single strand deoxynucleotide comprises one or more CpG dinucleotides. When used in combination with rabies vaccine, HBV vaccine or other vaccines, the adjuvant can significantly improve the immune effect of the vaccine.

Abstract: The present invention includes cold-adapted, acid-fast bacterium for use as a vaccine and a vaccine vector. In preferred embodiments, the cold-adapted, acid-fast bacterium is a Mycobacteria, for example, Mycobacteria shottsii.

Abstract: The invention provides a nucleotide sequence representing a pathogenicity island found in species of pathogenic mycobacteria. The islands are shown as SEQ ID NOS: 3 and 4 and comprises several open reading frames encoding polypeptides. These polypeptides and their use in diagnosis and therapy form a further aspect of the invention.

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 covalent binding site of myristate (SEQ ID NOS: 1-3) on the HIV matrix protein. The present invention contemplates three categories of embodiments: protein or protein fragments (SEQ ID NO: 1), messenger RNA, or DNA/RNA (SEQ ID NOS:2-3). DNA/RNA compositions may be either naked or recombinant. The present invention further contemplates use with a variety of immune stimulants.

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: Expression vectors that can efficiently produce virion capsid protein, tumor-associated protein of human papillomavirus on a microbial surface. Bacterial strains harboring such surface display vectors, and the use of the bacterial strains or their extracts or purified products as complex vaccines, are also described. The surface display vectors contain one or more than two genes selected from among pgsB, pgsC and pgsA, encoding a poly-?-glutamic acid synthetase complex (pgsBCA) of a Bacillus sp. strain, and genes that encode virion capsid proteins, tumor-associated proteins of human papillomavirus. Methods for preparing the foregoing vectors, vaccines and transformed microorganisms are also described.

Abstract: The invention pertains to conjugates of the capsular polysaccharide of Vibrio cholerae O139, or a structurally and/or immunologically related oligo- or poly-saccharide, and a carrier. These conjugates are useful as pharmaceutical compositions and/or vaccines to induce serum antibodies which have bactericidal (vibriocidal) activity against V. cholerae, in particular V. cholerae O139, and are useful to prevent, treat and/or reduce the severity of disease caused by V. cholerae infection, such as cholera. The present invention also relates to diagnostic tests for V. cholerae infection, and/or cholera caused by V. cholerae infection, using one or more of the oligo- or poly-saccharide-carrier conjugates or antibodies described above.

Abstract: Provided are mycobacteria comprising (a) a mutation that is not in a SecA2 gene that attenuates the virulence of the mycobacteria in a mammalian host, and (b) a mutation in a SecA2 gene that eliminates SecA2 activity. Also provided are mycobacteria that comprise a mutation in a SecA2 gene that eliminates SecA2 activity, where the mycobacteria are not Mycobacterium tuberculosis or Mycobacterium smegmatis. Additionally provided are methods of inducing an immune response in a mammal and methods of inducing an immune response to a pathogenic mycobacterium in a human using the above mycobacterial mutants.

Abstract: A method of enhancing expression of a desired protein at mucosal effector sites, the method including placing the protein to be expressed under the control of a promoter having SEQ ID NO: 2, SEQ ID NO: 3 or SEQ ID NO: 4, or a fragment or variant of any of these that has promoter activity, and causing expression in mucosal cells. Constructs used in the methods, as well as suitable recombinant gut-colonising microorganisms such as a Salmonella spp., are also described. Such organisms are useful in the preparation of 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: Disclosed are novel methods for combating diseases characterized by deposition of amyloid. The methods generally rely on immunization against amyloidogenic proteins (proteins contributing to formation of amyloid) such as beta amyloid (A?). Immunization is preferably effected by administration of analogues of autologous amyloidogenic polypeptides, said analogues being capable of inducing antibody production against the autologous amyloidogenic polypeptides. Especially preferred as an immunogen is autologous A? which has been modified by introduction of one single or a few foreign, immunodominant and promiscuous T-cell epitopes while substantially preserving the majority of A?'s B-cell epitopes. Also disclosed are nucleic acid vaccination against amyloidogenic polypeptides and vaccination using live vaccines as well as methods and means useful for the vaccination.

Abstract: The present invention provides methods of treating, protecting against, and inducing immune response against cervical cancer, comprising the step of administering to a sub recombinant Listeria strain, comprising a fusion peptide that comprises an LLO fragment a E7 and/or E6 antigen. The present invention also provides methods for inducing an anti-E7 response in a human subject and treating HPV-mediated diseases, disorders, and symp comprising administration of the recombinant Listeria strain.

Abstract: Improved, low cost vaccines for administration to living subjects such as mammals and birds are provided, which include killed recombinantly modified microorganisms (whole cell recombinant bacterin vaccine), the latter including recombinant DNA encoding at least one protective protein (e.g., an antigenic protein) which has been expressed by the microorganisms prior to killing thereof. The protective protein(s) are operable to prevent or reduce the severity of a disease of the subject. The vaccine preparations of the invention do not require separation of the protective protein(s) from the host recombinant microorganism(s), thereby materially decreasing the complexity and cost of the vaccine formulations. A preferred vaccine against kennel cough includes recombinantly modified microorganisms which express protective antigens containing pertactin and filamentous hemagglutinin protein products.

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 invention concerns an acellular immunogenic or vaccine composition for producing antibodies against Bacillus anthracis comprising a protective antigen (PA) and killed and optionally purified spores, obtained from mutating strains of Bacillus anthracis and their uses.

Abstract: The present invention generally provides methods and compositions for eliciting an immune response against Neisseria spp. bacteria in a subject, using vesicle vaccines made from Neisseria strains have decreased or no detectable expression of a product of LpxL1 gene, and which optionally overexpress fHbp.

Abstract: The present invention relates to mycobacterial lipoarabinomannan cap-specific mannosyl transferases and nucleic acid encoding such transferases. The invention further relates to Mycobacteria in which the lipoarabinomannan cap-specific mannosyl transferases have been inactivated and that therefore express mannose cap-deficient lipoarabinomannan. Such Mycobacteria with mannose cap-deficient lipoarabinomannan may be used as more effective vaccines against mycobacterial diseases as they lack the immunosuppressive action of the mannose cap.

Abstract: A method of using selective binding properties of killed and live isolates of Mycobacterium avium subspecies paratuberculosis (Map) to gastrointestinal tract mucosa is described which permits: selecting as a killed Map test candidate for oral administration a strain of Map which will have greater organismal attachment; and selecting as a live Map test candidate for oral administration a live strain of Map whose virulence had been significantly reduced and which exhibits a diminished ability to bind to gastrointestinal mucosa The method also includes preservation of binding ability of Map isolates after inhibition of organism replication or virulence reduction.

Abstract: Compounds and methods for the diagnosis and treatment of Chlamydial infection are disclosed. The compounds provided include polypeptides that contain at least one antigenic portion of a Chlamydia antigen and DNA sequences encoding such polypeptides. Pharmaceutical compositions and vaccines comprising such polypeptides or DNA sequences are also provided, together with antibodies directed against such polypeptides. Diagnostic kits containing such polypeptides or DNA sequences and a suitable detection reagent may be used for the detection of Chlamydial infection in patients and in biological samples.

Abstract: The disclosure below provides a protein export system for efficiently producing recombinant protein from a host cell. In a preferred embodiment, the protein export system utilizes protein export machinery endogenous to the host bacterium into which the protein export system vector is introduced.

Abstract: The present invention is related to a combination comprising a first constituent and a second constituent, wherein the first constituent is a bacterial cell which comprises at least one recombinant nucleic acid molecule encoding a phagolysosomal escape peptide or polypeptide; and wherein the second constituent is a biologically active agent. In certain embodiments, the combination is of use as a vaccine to induce an immune response in a mammal.

Abstract: This disclosure relates to a modified version of cyanovirin-N protein and a transformed Lactobacillus bacterium that is capable of recombinantly expressing this modified protein. Further disclosed are polynucleotide sequence encoding the modified cyanovirin-N protein, expression cassette that allows the expression of the modified protein, and method of make and use of the modified protein as well as the transformed Lactobacillus bacterium. In addition, this disclosure describes two novel promoters originated from L. jensenii, which are capable of directing a high level of gene expression in Lactobacillus bacteria. Also described are an expression cassette comprising one of the novel promoters, a genetically modified Lactobacillus bacterium containing the expression cassette, a method for recombinant gene expression in Lactobacillus bacteria using the novel promoters, and a method for delivery of proteins with desired biological activity to a mucosal surface in a human.

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: 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: The present invention relates to a pharmaceutical composition providing protective unity against a broad spectrum of Salmonella enterica serovars.

Abstract: The invention provides lipid A deficient mutant Neisseria meningitidis cells, pharmaceutical compositions incorporating such cells, and methods of using such cells.

Abstract: The present invention pertains to Bordetella bacteria having a double mutation, a first mutation in a gene of the Type III secretion system and a second mutation in a gene of the adenylate cyclase toxin (CyaA) locus of the bacteria so that the mutations result in no Type III secretion system, a non-functional Type III secretion system, no CyaA protein, or a non-functional CyaA protein or a combination thereof. The Bordetella bacteria double mutant is attenuated while maintaining the efficacy of the bacteria to elicit an immune response. The present invention also pertains to vaccine compositions and methods for treating and immunizing a mammal against a disease caused by infection of Bordetella bacteria or a disease caused by a pathogen.

Abstract: Disclosed is a method for inducing an immune response against autologous Epidermal Growth Factor Receptor (EGFR) in humans. The method comprises effecting uptake by antigen presenting cells of epitopes (preferably all) from the extracellular portion of human EGFR and of at least one non-human T helper epitope (TH epitope) so as to induce antibodies against EGFR. Immunization may be accomplished by protein vaccination, nucleic acid vaccination and live or viral vaccination. The immune response is useful in treatment of malignancies. Also disclosed are modified EGFR proteins and expression plasmids useful for the immunization method as well as recombinant gene technology tools such as nucleic acids, vectors and host cells.

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: This invention provides recombinant peptides comprising a fragment of an IgE constant region, nucleotide molecules encoding same, recombinant vaccine vectors comprising same, and methods for inducing immune response and treating allergy, asthma and IgE mediated disease comprising same.

Abstract: Mutant cholera holotoxins comprising a cholera toxin subunit A having single amino acid substitutions in the amino acid positions 16 or 72 or a double amino acid substitution in the amino acid positions 16 and 68 or 68 and 72 have reduced toxicity compared to the wild-type cholera holotoxin. The mutant cholera holotoxins are useful as adjuvants in immunogenic compositions to enhance the immune response in a vertebrate host to a selected antigen from a pathogenic bacterium, virus, fungus, or parasite, a cancer cell, a tumor cell, an allergen, or a self-molecule.

Abstract: The invention relates to preparations of bacterial ghosts which are substantially free of living bacterial cells and/or nucleic acids and their use in pharmaceutical preparations.

Abstract: N. gonorrhoeae is a bacterial pathogen which causes diseases including gonorrhoea, urethritis, cervicitis and pelvic inflammatory disease. In addition, like other inflammatory SYDs, infection is believed to enhance HIV transmission. Within the many proteins of the gonococcal *enome, six have been found to be particularly suitable for immunisation purposes, particularly', when used in combinations. The invention therefore provides a composition comprising two or more of the following antigens: (1) OmpA; (2) OmpH; (3) PPIase; (4) ngs41; (5) ngsl 17; and (6)', App.

Abstract: The present invention relates to a composition for an immunopotentiator (adjuvant) containing poly-gamma-glutamic acid and a composition for a vaccine containing the immunopotentiator, and more particularly, to an immunopotentiator containing poly-gamma-glutamic acid capable of enhancing antibody production rate by administering it to an animal together with antigen having low immunogenicity, and a composition for a vaccine containing the immunopotentiator and antigen. The inventive adjuvant has almost no toxicity and side effects, and show high antibody titer even when it is used with antigen having poor immunogenicity, so it can be used by adding to medical composition including preventive or curative vaccine for non-contagious chronic diseases as well as cancer, especially prostatic carcinoma, colon carcinoma, lung cancer, breast cancer, ovarian cancer, head and neck cancer, pudendum cancer, bladder cancer, brain tumor and glioma.

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 provides a vaccine, method of use, and kit employing genetically isolated and stabilized, live attenuated bacterial strains including Salmonella that express one or more avian influenza antigens for use in live vaccine compositions that can be orally administered to an individual to protect against avian influenza. Genetic stabilization may be achieved through deletion of IS200 elements and bacteria phage and prophage elements. The bacterial strains may be genetically isolated from external phage infection by constitutive expression of a P22 phage repressor.

Abstract: Adjuvant compositions comprising an effective amount IL-12 and QS-21 are disclosed. Immunogenic, vaccine and pharmaceutical compositions comprising a mixture of antigen and an adjuvant composition comprising an effective amount of IL-12 and QS-21 are also disclosed. These compositions elicit functional cell-mediated and humoral immune responses against at least one antigen. Methods of using the disclosed compositions are also disclosed.

Abstract: Disclosed herein are methods for inducing an immunological CTL response to an antigen by sustained, regular delivery of the antigen to a mammal so that the antigen reaches the lymphatic system. Antigen is delivered at a level sufficient to induce an immunologic CTL response in a mammal and the level of the antigen in the mammal's lymphatic system is maintained over time sufficient to maintain the immunologic CTL response. Also disclosed is an article of manufacture for delivering an antigen that induces a CTL response in an animal.

Abstract: Novel mycobacterial sulfation pathway proteins and polypeptides related thereto, as well as nucleic acid compositions encoding the same, are provided. The subject polypeptide and nucleic acid compositions find use in a variety of applications, including research, diagnostic, and therapeutic agent screening applications. Also provided are methods of inhibiting growth and/or virulence of a pathogenic mycobacterium, and methods of treating disease conditions associated with a pathogenic mycobacterium, particularly by administering an inhibitor of a mycobacterial sulfation pathway protein. The present invention further provides genetically modified mycobacteria having a defect in a sulfation pathway enzyme gene; and immunogenic compositions that include such genetically modified mycobacteria.

Abstract: The integration of genes into methylobacterium, such as M. extorquens ATCC 55366 is disclosed, using a transposon system, preferably the mini-Tn7 transposon system, and under the control of a promoter, such as the strong methanol dehydrogenase promoter (PmxaF). Multicopy integration of genes of interest is also disclosed. The unique and specific attachment site for the Tn7 attachment (attTn7) is identified for M. extorquens.

Abstract: A novel protein which has an activity to transport hydantoin compounds is described, as well as a recombinant expressing this transporter protein. From Microbacterium liquefaciens strain AJ3912, a novel gene was discovered to encode a protein which is able to transport hydantoin compounds. A recombinant with an excellent ability to uptake hydantoin compounds is obtained by introducing and expressing the novel gene, called mhp, using gene recombination techniques.

Abstract: The present invention relates to the use of the digestive tract of an animal as a bioreactor for the production of a product of interest.

Abstract: Vaccines based on one or more combinations of majorly abundant extracellular products of pathogens and methods for their use and production are presented. The most prevalent or majorly abundant extracellular products of a target pathogen are selected irrespective of their absolute molecular immunogenicity and used as vaccines to stimulate a protective immune response in mammalian hosts against subsequent infection by the target pathogen. The majorly abundant extracellular products may be characterized and distinguished by their respective N-terminal amino acid, amino acid, or DNA sequences. As the vaccines may comprise different combinations of the extracellular products, subunits thereof, or encoding nucleic acids, a broad range of effective immunotherapeutic compositions are provided by the present invention. In addition to other infectious agents, the vaccines so produced can be used to stimulate an effective immune response against intracellular pathogens and in particular Mycobacterium tuberculosis.

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

Abstract: A method of producing a thy A?strain of vibrio cholerae comprising the step of site-directed mutagenesis in the V. cholerae chromosome at the locus of the thy A gene SEQ ID NO: 1 of FIG. 1, is described. Particularly, a ? thy A strain of Vibrio cholerae lacking the functionality of the thy A is disclosed. This strain may comprise one or several episomal autonomously replicating DNA elements, such as plasmids, having an optionally foreign, e.g. E. coli, functional thy A gene that enables the strain to grow in the absence of thymine in the growth medium, and optionally having a structural gene encoding a homologous or heterologous protein. Further, proteins encoded by a structural thy A gene and the 5?-flanking region are described as SEQ ID NO: 4 of FIG. 4 and SEQ ID NO: 5 of FIG. 5, respectively. Additionally, a vaccine comprising a Vibrio cholerae ? thy A strain of the invention or a thy A?strain of Vibrio cholerae produced by the method of the invention is disclosed.

Abstract: Outer-membrane vesicles, Class 1 outer membrane proteins of Neisseria meningitidis, fragments or oligopeptides containing epitopes of the Class I OMP can be used to immunize against meningococcal disease.