Abstract: The invention provides an attenuated enterobacterium comprising an attenuating mutation in the fnr gene, and optionally further comprising a heterologous nucleic acid encoding a foreign antigen. Also provided are pharmaceutical formulations comprising the attenuated enterobacteria of the invention. Further disclosed are methods of inducing an immune response in a subject by administration of an immunogenically effective amount of an attenuated enterobacterium or pharmaceutical formulation of the invention.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: The present invention relates to novel Salmonella mutants, to a process for producing same and to vaccines containing same, wherein said Salmonella mutants are characterized in that they elicit a humoral response that can be distinguished from the humoral response elicited by the wild type strains. It is accordingly an object of the present invention to provide the use of said Salmonella mutants as serological marker strains in the vaccination of animals, in particular mammals and birds, more in particular cattle, poultry and pigs. The serological marker vaccine is of special value in animal farming and provides a (long-lasting) immunization against a wide range of Salmonella strains. The novel mutants are non-reverting and can be used for the efficient immunization of mammals and birds.

Abstract: The present invention concerns a pharmaceutical composition comprising at least one agonist of at least one Toll Like receptor (TLR) chosen from TLR 4 and 9, for use in the prophylactic treatment of septic complications of post-traumatic systemic immunodepression in a patient who has suffered one or more severe traumatic injuries and is hospitalized in particular in an intensive care unit. Preferably, said TLR 4 agonist is monophosphoryl lipid A (MPLA) or deacylated 3-O-monophosphoryl lipid A (3D-MPLA) and said TLR 9 agonist is a CpG oligodeoxynucleotide (CpG ODN).

Abstract: The present invention provides a method for the treatment and/or prevention of bacterial infection caused by Enterobacteriaceae bacteria in central nervous system and/or peripheral blood circulation in a mammal by administering effective amount of outer membrane protein A (OmpA) or its derivatives to a mammal. Also provided are a method for vaccinating a mammal to produce an antibody against bacterial infection caused by Enterobacteriaceae family in central nervous system and/or peripheral blood circulation and a method of detecting or diagnosing bacterial infections caused by Enterobacteriaceae family in central nervous system and/or peripheral blood circulation in a mammal. An antibody and a kit on the basis of the vaccinating method and detecting/diagnosing method are also provided.

Abstract: A two stage size filtration process is used to purify immunogenic bacterial vesicles. A first step separates the vesicles from intact bacteria based on their different sizes, with the smaller vesicles passing into the filtrate (permeate). A second step then uses a finer filter to remove smaller contaminants, with the vesicles remaining in the retentate. This two stage process is extremely simple to operate but has been shown to give vesicles of high purity.

Abstract: According to the present invention, there is provided a means of expressing and displaying a protein on the cell surface of a bifidobacterium. In the gene for expressing a protein on the surface of a bifidobacterium of the present invention, a gene coding for a bifidobacterium-derived GNB/LNB substrate-binding membrane protein and a gene coding for the target protein or peptide are linked in this order from the 5? end side. Thus, a bifidobacterium transformed by introducing the gene for expressing a protein on the surface of a bifidobacterium of the present invention expresses the target protein or peptide on the surface thereof. When the target protein or peptide is an antigen protein or an antigen peptide, the transformed bifidobacterium of the present invention is useful as an oral vaccine.

Abstract: Methods for making and using therapeutic formulations of Proteosome-based immunoactive compositions are provided. The immunogenic compositions, which include Proteosomes and liposaccharides, may be used to elicit or enhance a nonspecific innate immune response to, for example, treat or prevent infectious disease. In addition, after activating the innate immune system, immunogenic compositions further containing an antigen may be used to elicit a specific adaptive immune response. Furthermore, provided are compositions capable of altering hyperreactive responses or inflammatory immune responses, such as allergic reactions. Such compositions may be used as a prophylactic, or in various clinical settings to treat or prevent infectious disease (such as parasite, fungal, bacterial or viral infections), or to alter inappropriate inflammatory immune responses (such as allergic reactions or asthma).

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

Abstract: The present invention provides compositions including siderophore receptor polypeptides from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: The present invention relates to an immunogen-carrier having immunopotentiating or adjuvant properties. More particularly, the immunogen-carrier is a virus-like particle (VLP) from the family of potexvirus, and most particularly the papaya mosaic virus. The VLP produced by recombinant techniques is in fusion with one of its own proteins a protein immunogen. The above VLP and a protein or a protein extract from a viral, bacterial or parasital pathogen may be used as a vaccine.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: The present invention relates to a method of coating a spore with one or more therapeutic agents. The present invention also relates to a coated spore obtained by the method of the present invention and the use of the coated spore as a vaccine.

Abstract: The present invention relates to immunogenic compositions containing an antigen of interest entrapped with a crosslinked carrier protein matrix, methods of making such vaccines, and methods of vaccine administration, wherein the immunogenicity of the protein matrix, and hence its effectiveness as a vaccine, is improved by controlling or selecting the particle size of the protein matrix particles to eliminate low molecular weight particles, e.g., less than 100 nm in diameter.

Abstract: A typhoid vaccine using heat shock protein (Hsp) of Salmonella typhi and a method for the manufacture thereof. A composition comprising an effective amount of a complex of a Hsp, in part or whole, either alone or covalently or non-covalently bound to an antigenic molecule, which when administered to a mammal elicits specific immunological responses in the host. The antigenic molecule refers to the exogenous antigens/immunogens such as viz LPS, peptide, nucleic acid or polysaccharide or antigenic/immunogenic fragments and derivatives thereof.

Abstract: The invention provides therapeutics and methods to induce a mammalian host, including a human, to produce antibodies, which agonize death receptors and cause the apoptotic death of target cells within the host's body. The therapeutics are vaccine compositions, including genetic vaccines encoding death receptor antigens of the tumor necrosis factor receptor family. Also provided are means and methods for overcoming host immunological tolerance to death receptors. The vaccines are useful against cancer cells and other death receptor bearing target cells within the host, and can be used in both therapeutic and prophylactic settings. The vaccines are also useful for diagnostic testing of the immunocompetence of a host.

Abstract: The present invention is directed to a composition, kit and method for delivering a soft flowable gel to a flock of poultry in barns, but can also be used in hatcheries or free range farms, for treating poultry with a therapeutic agent. The soft flowable gel comprises water, a gelling agent, a therapeutic agent and between about 0.05% and 0.15% xanthan gum.

Abstract: The present invention relates to a Salmonella strain suitable as a marker vaccine having an inactivated gene.

Abstract: Populations of Salmonella in animals may be substantially reduced by treatment with a vaccine composition which has been produced by exposing whole, intact cells of a Salmonella species to irradiation with an electron beam under conditions effective to kill the cells. The electron beam irradiated cells of Salmonella are effective for stimulating protective immune responses in the animals against the Salmonella. Induction of these immune responses significantly reduces or eliminates the colonization of the animal by the Salmonella, and consequently reduces or eliminates the shedding of Salmonella in the feces of the animals.

Abstract: The present invention relates to live attenuated bacteria for use in a medicament. The invention also relates to vaccines based upon such bacteria useful for the prevention of microbial pathogenesis and to the use of such bacteria for the manufacture of a vaccine. Finally, the invention relates to methods for the preparation of such vaccines.

Abstract: A live attenuated derivative of a pathogenic bacterium intended for use as a vaccine.

Abstract: Various nucleic acid-based matrixes are provided, comprising nucleic acid monomers as building blocks, as well as nucleic acids encoding proteins, so as to produce novel biomaterials. The nucleic acids are used to form dendrimers that are useful as supports, vectors, carriers or delivery vehicles for a variety of compounds in biomedical and biotechnological applications. In particular, the macromolecules may be used for the delivery of drugs, genetic material, imaging components or other functional molecule to which they can be conjugated. An additional feature of the macromolecules is their ability to be targeted for certain organs, tumors, or types of tissues. Methods of utilizing such biomaterials include delivery of functional molecules to cells.

Abstract: The present invention provides compositions including polypeptides having the characteristics of polypeptides expressed by a reference microbe such E. coli or Salmonella. Examples of Salmonella strains that can be used include, for instance, S. enterica serovar Newport, S. enterica serovar Enteritidis, S. enterica serovar Typhimurium, and S. enterica serovar Dublin. Also provided are compositions including polypeptides having a particular molecular weight and a mass fingerprint that includes polypeptide fragments having a particular set of masses, or polypeptides having an amino acid sequence with at least about 95% identity with an amino acid sequence, wherein the polypeptide has seroreactive activity. The present invention also provides methods of making and methods of using such compositions.

Abstract: The invention provides an attenuated enterobacterium comprising an attenuating mutation in the fnr gene, and optionally further comprising a heterologous nucleic acid encoding a foreign antigen. Also provided are pharmaceutical formulations comprising the attenuated enterobacteria of the invention. Further disclosed are methods of inducing an immune response in a subject by administration of an immunogenically effective amount of an attenuated enterobacterium or pharmaceutical formulation of the invention.

Abstract: The present invention provides compositions including polypeptides having the characteristics of polypeptides expressed by a reference microbe such E. coli or Salmonella. Examples of Salmonella strains that can be used include, for instance, S. enterica serovar Newport, S. enterica serovar Enteritidis, S. enterica serovar Typhimurium, and S. enterica serovar Dublin. Also provided are compositions including polypeptides having a particular molecular weight and a mass fingerprint that includes polypeptide fragments having a particular set of masses, or polypeptides having an amino acid sequence with at least about 95% identity with an amino acid sequence, wherein the polypeptide has seroreactive activity. The present invention also provides methods of making and methods of using such compositions.

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

Abstract: The present invention provides a cellular vaccine for therapeutic or prophylactic treatment of a pathological condition, the vaccine comprising or consisting of a population of CD 4+ T cells modified such that they contain an antigenic component, and/or a nucleic acid molecule encoding an antigenic component thereof, wherein the T cells are (a) activated, or capable of being activated, and (b) apoptotic, or capable or being made apoptotic. The invention further provides an adjuvant composition for use in a method of vaccination, the composition comprising or consisting of a population of T cells, wherein the T cells are (a) activated, or capable of being activated, and (b) apoptotic, or capable or being made apoptotic.

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: The invention concerns novel Salmonella enterica attenuated strains, characterized in that they are inactivated at the level of the znuABC operon through mutation in at least one of the znuA, znuB, znuC genes of such operon, for uses in medical or veterinary fields as vaccines.

Abstract: Disclosed are dosage forms and related methods, that include a first population of synthetic nanocarriers that have one or more first antigens coupled to them, one or more second antigens that are not coupled to the synthetic nanocarriers, and a pharmaceutically acceptable excipient.

Abstract: The present invention relates to the field of vaccination against Salmonella in animals, particularly avian animals. The present invention also encompasses kits and uses of Salmonella immunogenic compositions or vaccines. The present invention further relates to methods and compositions comprising at least one primo-administration of an attenuated immunogenic composition or vaccine, comprising a pharmaceutically or veterinarily acceptable excipient, diluent or vehicle and at least one attenuated Salmonella, administered to an avian animal before at least one boost-administration of an inactivated immunogenic composition or vaccine, comprising a pharmaceutically or veterinarily acceptable excipient, diluent or vehicle, and at least one inactivated Salmonella.

Abstract: Abstract of the Disclosure Methods for synthesis and manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency, such that a simplified purification process can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

Abstract: The present invention encompasses recombinant bacteria and immunogenic compositions comprising the bacteria. The immunogenic composition may be used to induce an immune response against C. perfringens.

Abstract: The present invention describes compositions comprising tumor cell debris, tumor lysate or tumor antigens and methods of using tumor cell debris, tumor lysate or tumor antigens for stimulating a specific immune response. The compositions may further comprise at least one TLR ligand. The stimulation of the specific immune response may be used to treat tumors, particularly, brain tumors. The treatment method may also reduce the recurrence of a tumor and/or inhibit or slow down the growth of a tumor.

Abstract: This invention provides compositions and methods for stabilizing a live attenuated virus in dried formulations. In particular, compositions and methods of preparing a dried vaccine are provided that stabilize the viability of live vaccines such as measles and adenovirus at room temperature.

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: The invention relates to vaccine compositions comprising chitosan and a vaccine which are administered to avian species via the ocular route, and methods or programs of vaccination including use of chitosan in order to increase or enhance cell-mediated immunity in avian species and persistence of the vaccine avian tissues.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: OmpD of non-typhoidal Salmonella (NTS), e.g. as derivable from Salmonella Typhimurium, and immunogenic fragments thereof are proposed for use in treating or preventing NTS infection and/or disease. OmpD of S. paratyphi and fragments thereof are also now of interest for vaccine use.

Abstract: Methods are disclosed for treating or preventing graft versus host disease in a subject. The methods include selecting a subject in need of treatment for graft versus host disease; and administering to the subject a therapeutically effective amount of a TLR5 agonist such as a flagellin polypeptide, or a polynucleotide encoding the flagellin, thereby treating or preventing graft versus host disease in the subject. Methods are also disclosed for reducing susceptibility to an opportunistic infection in a subject who is a bone marrow transplant recipient. The methods include selecting a subject who has had a bone marrow or hematopoietic stem cell transplant; and administering to the subject a therapeutically effective amount of a TLR5 agonist such as a flagellin polypeptide or a polynucleotide encoding the polypeptide, and administering to the subject an effective amount antigen of the opportunistic infection, thereby reducing the susceptibility to the opportunistic infection in the subject.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: Therapeutic methods for treatment of solid tumor cancer cell masses, as can be effected using therapeutic compositions comprising Salmonella species/strains and related compositions.

Abstract: Adjuvants comprising OmpC porin, OmpF porin, or a combination thereof, are provided. The adjuvants can be administered to a subject in combination with antigenic material in order to potentiate the immunogenic effect of the antigenic material. Also provided are products comprising antigenic material in combination with OmpC and/or OmpF, including products comprising a pre-formulated vaccine in combination with OmpC and/or OmpF. Further provided is the use of OmpC and/or OmpF to improve the effect of a pre-formulated vaccine.

Abstract: An antigen composition for stimulating an immune response in an inoculated avian species to at least one intestinal pathogenic organism includes seven field strains of E. coli, Pseudomona aeruginosa, Aerobacter aerogenes, Salmonella enteritidis, Salmonella typhimurium, Salmonella agona, and Salmonella Kentucky. The antigen composition can be used alone or in combination with a Marek's Disease vaccine to reduce shedding of E. coli and/or Salmonella bacteria.

Abstract: The invention provides novel adjuvants and pharmaceutical composition comprising of an adjuvant alone. The invention also provides novel vaccine compositions comprising of an antigen and a novel adjuvant. The novel adjuvant as per present invention is farnesoid-X-receptor (FXR) antagonist. The invention also relates to an adjuvant for variety of antigens. The adjuvant improves antibody production specific to incorporated antigen. The adjuvant also induces cell mediated immune response.

Abstract: Improved (safer and more effective) methods of therapy using TNF-R agonists, e.g., CD40 agonists are provided. These methods provide for the addition of an amount of a type 1 interferon and/or a TLR agonist that is effective to prevent or reduce the toxicity (liver toxicity) that may otherwise result in some patients of the TNF-R agonist is used as a monotherapy (without the type 1 interferon and/r TLR agonist).

Abstract: Vaccines comprising fliC and CD 154 polypeptides and Salmonella enteritidis vaccine vectors comprising fliC polypeptides are provided. Also provided arc methods of enhancing an immune response against flagellated bacteria and methods of reducing morbidity associated with infection with flagellated bacteria.

Abstract: The present invention provides compositions including siderophore receptor polypeptides from gram negative microbes, and preferably, lipopolysaccharide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions, including inducing the production of antibody in an animal.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions, including inducing the production of antibody in an animal.