Abstract: Compositions and methods effective to provide therapeutic benefit for disorders of the central nervous system via oral or systemic delivery of therapeutic proteins produced in plastids are disclosed.

Abstract: Bacterial flagellin protein is modified to improve adjuvant activity.

Abstract: Compositions and methods are provided for converting chitin into N-acetylglucosamine, glucosamine and ethanol. The chitin may be used directly from the environment, for example, as occurs in invertebrate cuticles, fungal cells and/or algae. Mutant bacteria were created by knocking out or inactivating one or more genes preferably resulting in the chitin catabolic sensor maintaining an activated state. Methods are further provided for converting the N-acetylglucosamine into ethanol by means of a genetically engineered yeast strain which can be optionally co-cultivated with the Vibrionaceae to produce significant yields of ethanol.

Abstract: Disclosed herein are methods of increasing epithelial cell proliferation (such as intestinal epithelial cell proliferation) by contacting epithelial cells with one or more CBPs. In some examples, the methods include administering the CBP to a subject, such as a subject in need of increased epithelial cell proliferation. Also disclosed herein are methods of identifying a subject having or at risk of developing hyperproliferation of epithelial cells (such as intestinal epithelial cells). Further disclosed are methods of decreasing epithelial cell proliferation by decreasing expression and/or activity of a CBP and methods of identifying inhibitors of epithelial cell proliferation and/or CBP activity.

Abstract: This invention provides diatom-based vaccines.

Abstract: The present invention relates to chimeric protein vaccines and methods of use thereof in the treatment of Staphylococcus aureus. One embodiment of the present invention provides a method of generating an immune response in a mammal, that includes administering to the mammal, a composition having a chimeric protein having at least one of: a portion of a cholera toxin, a portion of a heat-labile toxin, and a portion of a shiga toxin; and an antigen having at least one of: an antigenic material from S. aureus and an antigenic material from a S. aureus-specific polypeptide.

Abstract: In one aspect, the present disclosure provides compounds of formulae (I) and (II). In another aspect, a compound of formula (I) or (II) is formulated into compositions with an antigen, optionally with a vesicle. In some embodiments, compositions are administered intramuscularly.

Abstract: The disclosure 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 disclosure 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: The present invention relates to chimeric protein vaccines and methods of use thereof in the treatment of Staphylococcus aureus. One embodiment of the present invention provides a method of generating an immune response in a mammal, that includes administering to the mammal, a composition having a chimeric protein having at least one of: a portion of a cholera toxin, a portion of a heat-labile toxin, and a portion of a shiga toxin; and an antigen having at least one of an antigenic material from S. aureus and an antigenic material from a S. aureus-specific polypeptide.

Abstract: This document provides methods and materials involved in making and using liquid vaccine preparations for oral administration. For example, methods and materials for making and using liquid vaccine preparations for oral administration that include a lyophilized or dried vaccine component (e.g., a lyophilized pathogenic agent such as a lyophilized rotavirus preparation) and a liquid edible oil composition (e.g., a liquid edible oil composition containing one or more medium chain triglycerides) are provided. In some cases, liquid vaccine preparations that include a buffer component (e.g., CaCO3) are provided.

Abstract: A bivalent vaccine against Scuticociliatosis, Vibriosis and marine ich in zobaidy, sobaity and hamoor includes a formalin killed whole cell Vibrio encapsulated Uronema spp. The vaccine is made by collecting a mass of infected zobaidy and scraping the moribund fish with a plastic spatula to transfer live Uronema into a pretri dish. The cerebro-spinal fluid is removed from the zobaidy and added to the fluid containing the Uronema at different concentrations formed with the BHIB. A mass of zobaidy juvenile are fed a commercial pellet feed coated with formalin inactivated Uronema spp. encapsulated in Vibrio four times a day for a period of ten days.

Abstract: Provided herein are insoluble particles that include polypeptides. The polypeptides may have immunogenicity that is greater than the immunogenicity of the same polypeptides when they are not present in the particle. The polypeptides may be soluble before incorporation into the particles and insoluble after incorporation into the particles. The particles may include lipopolysaccharide, wherein the lipopolysaccharide is insoluble. The particles may include a carrier. In one embodiment, a carrier is present at no greater than 0.001 mg carrier/mg particles. In one embodiment, a carrier is present at a ratio of carrier to polypeptide (weight:weight) of no greater than 0.05:1. In one embodiment, a carrier is not detectable in the particles.

Abstract: The present invention relates to recombinant strains of Vibrio spp, which are unable to utilize the amino sugar N-acetylglucosamine (GlcNAc) as a sole carbon source. This inability to utilize GlcNAc severely impairs the colonization property of the recombinants. The present invention also provides compositions comprising these recombinant strains for use in pharmaceuticals and in providing immunity.

Abstract: The present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: The present invention provides a novel immunogenic composition, vaccine and methods for making and using the immunogenic composition and vaccine. The immunogenic composition is capable of providing an immune response and/or a protective immunity into subjects, preferably mammals, against microorganism-associated disease. The immunogenic composition includes one or more extracellular proteins isolated from a microorganism capable of providing an immune response and/or a protective immunity into subjects against microorganism-associated disease. The isolated extracellular proteins range in molecular weight from about 10,000 Da to about 220,000 Da. Suitable microorganisms may include members of the genus Salmonella, Listeria, Pseudomonas, Staphylococcus, and Vibrio. Kits are also encompassed for detection, diagnosis and prevention of microorganism-associated disease.

Abstract: The methods and compositions of the present invention are directed to a vaccine against Vibrio cholerae comprised of V. cholerae outer membrane vesicles (OMVs). Such vaccines are relatively stable, facilitating distribution. Inventive methods generally include administration of a vaccine against Vibrio cholerae by intranasal, intraperitoneal, oral or intragastric routes. Such vaccines confer immunity to the individual, and when administered to pregnant subjects, can be conferred to the offspring of individuals.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins 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: A bivalent vaccine against Scuticociliatosis, Vibriosis and marine ich in zobaidy, sobaity and hamoor includes a formalin killed whole cell Vibrio encapsulated Uronema spp. The vaccine is made by collecting a mass of infected zobaidy and scraping the moribund fish with a plastic spatula to transfer live Uronema into a pretri dish. The cerebro-spinal fluid is removed from the zobaidy and added to the fluid containing the Uronema at different concentrations formed with the BHIB. A mass of zobaidy juvenile are fed a commercial pellet feed coated with formalin inactivated Uronema spp. encapsulated in Vibrio four times a day for a period of ten days.

Abstract: A bacterial autoinducer, CAI-1, was purified and its structure identified. Methods for synthesis of the autoinducer and its analogues were elucidated. Methods of using the autoinducer or its analogues for treating bacterial pathogenicity and bio film formation are described. Methods for prevention and treatment of cholera are described. Synthetic (S)-3-hydroxytridecan-4-one functions as well as natural CAI-1 in repressing production of the virulence factor toxin co-regulated pilus (TCP). Strategies are described to manipulate bacterial quorum sensing in the clinical arena.

Abstract: The present invention relates to recombinant strains of Vibrio spp, which are unable to utilize the amino sugar N-acetylglucosamine (GlcNAc) as a sole carbon source. This inability to utilize GlcNAc severely impairs the colonization property of the recombinants. The present invention also provides compositions comprising these recombinant strains for use in pharmaceuticals and in providing immunity.

Abstract: The present invention describes the use of a mutant form of EtxB or CtxB to deliver an agent to a target cell wherein the mutant has GM-1 binding activity; but wherein the mutant has a reduced immunogenic and immunomodulatory activity relative to the wild type form of EtxB or CtxB.

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: Disclosed herein are flagellin mutants having an enhanced activity of stimulating the toll-like receptor-5 (hereinafter referred to as “TLR5”). More specifically, disclosed are flagellin mutants, prepared by point-mutating some of the amino acids of a TRL5 agonist flagellin so as to enhance the TRL-stimulating activity of the flagellin.

Abstract: Disclosed herein are flagellin mutants having an enhanced activity of stimulating the toll-like receptor-5 (hereinafter referred to as “TLR5”). More specifically, disclosed are flagellin mutants, prepared by point-mutating some of the amino acids of a TRL5 agonist flagellin so as to enhance the TRL-stimulating activity of the flagellin.

Abstract: A vaccine against cholera and/or ETEC is provided, comprising a Vibrio cholerae O1 cell, characterized in that said cell comprises O1 antigens of both Ogawa and lnaba serotypes. Genetically modified Vibrio cholerae O1 cells for use in such vaccines, DNA-constructs for the modification, uses for the vaccine and methods of making a vaccine are also provided.

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 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 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: Vibrio vulnificus can cause infections in aquaculture-raised fish and is considered an opportunistic human pathogen. We isolated V. vulnificus from diseased hybrid tilapia (Oreochromis niloticus X O. aureus) cultured in a North American water reuse aquaculture facility. We have characterized the isolate using biochemical and molecular methods, developed a disease infection model, and determined that formalin-inactivated whole-cell vaccine provides protection against V. vulnificus. The V. vulnificus isolate was determined to be biotype 1, 16S rRNA type B, vcg type C, and vvhA type 2. Fish vaccinated with the formalin-inactivated whole-cell vaccine responded to vaccination as measured by agglutinating antibody titer. In two separate trials, vaccinated tilapia exhibited relative percent survival of 73 and 60% following challenge with the homologous isolate. In additional trials, vaccinated tilapia exhibited survival values of up to 87.5% following challenge with a heterologous isolate.

Abstract: The invention provides immunostimulatory compositions and methods of administration thereof. Also provided are methods of administering a tryptanthrin compound in an effective amount to enhance the immune response of a subject to an antigen. Also provided are methods of administering an effective amount of a tryptanthrin to stimulate the immune response in a subject for the treatment of cancer. Further provided are methods of administering a tryptanthrin compounds as an immunotherapeutic in the treatment of infectious diseases.

Abstract: Disclosed herein are flagellin mutants having an enhanced activity of stimulating the toll-like receptor-5 (hereinafter referred to as “TLR5”). More specifically, disclosed are flagellin mutants, prepared by point-mutating some of the amino acids of a TRL5 agonist flagellin so as to enhance the TRL-stimulating activity of the flagellin.

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: 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: 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: 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: 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: 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.

Abstract: This invention relates to the stabilization of a bacterial ADP-ribosylating exotoxin class protein (bARE), a method for analysing a bARE class protein, a method for the stabilization of the bARE class bacterial protein, compositions comprising a stabilized bARE protein, compositions comprising a substantially integral bARE class protein and immunogenic composition formulations incorporating same.

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: A bifunctional composition comprising an intracellularly effective immunomodulating nucleic acid component containing at least one immunostimulatory, immunoinhibitory or immunomodulating motif and selected from a mononucleotide, a dinucleotide, an oligonucleotide or a polynucleotide with either a natural phosphodiester backbone or a modified backbone, optionally in combination with a specific antigen, in association with a protein binding to specific receptors on mammalian cell surfaces selected from the group consisting of cholera toxin (CT), the subunit B of CT (CTB), Escherichia coli heat labile enterotoxin (LT), the subunit B of LT (LTB), and proteins or protein derivatives that react with antiserum to CT or LT, bind to GM1 ganglioside, ADP-ribosylates an acceptor protein, or give rise to accumulation of cyclic AMP in target cells, and antibodies or other proteins which after binding to a specific cell surface component can be internalized into the cell, is described.

Abstract: The present invention provides a novel immunogenic composition, vaccine and methods for making and using the immunogenic composition and vaccine. The immunogenic composition is capable of providing an immune response and/or a protective immunity into subjects, preferably mammals, against microorganism-associated disease. The immunogenic composition includes one or more extracellular proteins isolated from a microorganism capable of providing an immune response and/or a protective immunity into subjects against microorganism-associated disease. The isolated extracellular proteins range in molecular weight from about 10,000 Da to about 220,000 Da. Suitable microorganisms may include members of the genus Salmonella, Listeria, Pseudomonas, Staphylococcus, and Vibrio. Kits are also encompassed for detection, diagnosis and prevention of microorganism-associated disease.

Abstract: Metabolic auxotroph of Vibrio cholerae 0139 synonym Bengal which has a mutation in its hem A gene and which is not capable of synthesizing aminolevulinic acid (ALA) de novo and which is obtained from a parent strain originally isolated from a patient's coproculture having all the identifying characteristics of Vibrio cholerae 0139 synonym Bengal is described. In this strain the hem A gene is mutated by inserting a kanamycin resistant gene cassette. Another metabolic auxotroph of Vibrio cholerae 01 E1 Tor where the hem A gene is mutated by a frame shift mutation is disclosed. Methods of producing the strains are disclosed.

Abstract: The present invention provides a Withania somnifera fraction rich in withanolides and a vaccine comprising a “Withania somnifera fraction” as an adjuvant.

Abstract: The present invention provides non-toxic Gram-negative bacteria. In particular, the present invention provides viable Gram-negative bacteria (e.g., E. coli) substantially lacking lipopolysaccharide (LPS, endotoxin) within the outer membrane. The present invention further provides methods of generating viable non-toxic Gram-negative bacteria and uses thereof. The present invention also provides compositions and methods for inducing immune responses and for researching and developing therapeutic agents.

Abstract: An immunogenic or vaccine composition comprising an immunoadjuvant compound consisting of a Rho GTPase activator. The Activators of Rho GTPases, namely the cytotoxic necrotizing factor 1 (CNF1), and DNT bear immunostimulatory properties towards the systemic response to orally administered ovalbumine.

Abstract: Described herein are methods for simultaneously immunizing a subject against Cholera and Malarial infection. Specifically exemplified herein are methods that involve administering compositions comprising a CTB-AMA1 or CTB-MSP1 derived from plants having plastids transformed to express such conjugates.

Abstract: Adjuvant combinations comprising at least one NKT activator, such as alpha-galactosylceramide (?-Gal-Cer) or iGb3, a CD40 agonist and optionally an antigen are disclosed. The use of these immune adjuvants for treatment of various chronic diseases such as cancers is also provided.

Abstract: The methods and compositions of the present invention are directed to a vaccine against Vibrio cholerae comprised of V. cholerae outer membrane vesicles (OMVs). Such vaccines are relatively stable, facilitating distribution. Inventive methods generally include administration of a vaccine against Vibrio cholerae by intranasal, intraperitoneal, oral or intragastric routes. Such vaccines confer immunity to the individual, and when administered to pregnant subjects, can be conferred to the offspring of individuals.

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