Abstract: In one aspect, the invention relates to an immunogenic composition that includes a mutant Clostridium difficile toxin A and/or a mutant Clostridium difficile toxin B. Each mutant toxin includes a glucosyltransferase domain having at least one mutation and a cysteine protease domain having at least one mutation, relative to the corresponding wild-type C. difficile toxin. The mutant toxins may further include at least one amino acid that is chemically crosslinked. In another aspect, the invention relates to antibodies or binding fragments thereof that binds to said immunogenic compositions. In further aspects, the invention relates to isolated nucleotide sequences that encode any of the foregoing, and methods of use of any of the foregoing compositions.

Abstract: Gastroretentive controlled release vehicles may, in some embodiments, (1) comprise a polymeric matrix and agents for the treatment, prevention, and/or mitigation of a disease and/or side effect thereof and (2) have both gastroretentive properties and controlled release properties. Preferrably, the polymeric matrix may comprise ethylene copolymers, ethyl celluloses, and/or thermoplastic polyurethanes that may optionally be partially crosslinked.

Abstract: Novel polynucleotide and amino acids of Brachyspira hyodysenteriae are described. These sequences are useful for diagnosis of B. hyodysenteriae disease in animals and as a therapeutic treatment or prophylactic treatment of B. hyodysenteriae disease in animals. These sequences may also be useful for diagnostic and therapeutic and/or prophylactic treatment of diseases in animals caused by other Brachyspira species.

Abstract: Chimera proteins including: (i) at least one sequence of a VlsE protein of a Borrelia species selected from B. garinii, B. burgdorferi sensu stricto and B. afzelii, and (ii) at least one sequence including sequences of the IR6 domain of B. burgdorferi sensu stricto, B. afzelii and B. garinii. Also, a method and a kit for the in vitro diagnosis of Lyme borreliosis using said proteins.

Abstract: The present invention relates to compositions, uses thereof, and methods of vaccinating cattle, particularly cows and heifers, against Leptospira borgpetersenii serovar hardjo (type hardjo-bovis) by using Leptospira interrogans serovar hardjo (type hardjoprajitno).

Abstract: The disclosure describes use of flagellin polypeptides to induce tolerance to gram negative bacteria, such as Pseudomonas aeruginosa, in order to alleviate the effects of the inflammatory response to bacterial infection in a patient. Also described are methods and compositions for treating and preventing keratitis, cystic fibrosis, asthma, and other diseases and conditions in which inflammation contributes to the pathology and symptoms.

Abstract: A headache can be treated more effectively by co-administration of a botulinum toxin and a triptan drug to a patient and/or the effectiveness of a triptan medication can be increased. The botulinum toxin can be botulinum toxin type A and the botulinum toxin can be administered to or to the vicinity of where a patient experiences or is predisposed to experience pain or a headache.

Abstract: The invention provides use of an EndoS polypeptide, or a polynucleotide encoding an EndoS polypeptide, in the manufacture of a medicament for the treatment or prevention of a disease or condition mediated by IgG antibodies.

Abstract: The present invention encompasses a recombinant bacterium comprising a regulated rfaH nucleic acid, as well as a vaccine comprising said recombinant bacterium. Other embodiments of the present invention encompass a recombinant bacterium comprising a regulated rfaH nucleic acid and a regulated rfc nucleic acid, while additional embodiments encompass a recombinant bacterium comprising a regulated rfaH nucleic acid and at least one nucleic acid encoding at least one exogenous antigen.

Abstract: A system and a method for the production of recombinant N-glycosylated target proteins. The system comprises a prokaryotic organism (e.g. Escherichia coli) into which is introduced a genetic information encoding for a metabolic apparatus capable of carrying out the requested N-glycosylation of the target protein. Said prokaryotic organism also contains the genetic information required for the expression of one or more recombinant target proteins. The metabolic apparatus preferably comprises specific glycosyltransferases for the assembly of the oligosaccharide on a lipid carrier and an OTase that covalently links this oligosaccharide to specific residues of the desired protein.

Abstract: The present application discloses an immunogenic composition comprising a Hib saccharide conjugate, at least one additional bacterial, for example N. meningitidis, saccharide conjugate(s), and a further antigen selected from the group consisting of whole cell pertussis and hepatitis B surface antigen, wherein the saccharide dose of the Hib saccharide conjugate is less than 5 ?g.

Abstract: The current invention relates to the diagnosis and treatment of diseases resulting from infections by Mycobacterium avium subsp. paratuberculosis. In particular the invention relates to the use of an antigen selected among (a) a synthetic peptide 5P having the following formula: DPhe-NMeVal-Ile-Phe-Ala-OMe (SEQ ID NO: 1); (b) a lipopeptide L5P consisting of the synthetic peptide a) wherein the N-terminal phenylalanine residue is N-acylated with an eicosanoic acid acyl chain; (c) a variant of peptide a) or lipopeptide b) able to react with anti-Mycobacterium paratuberculosis antibodies; for in vitro detection or quantification of specific anti-Mycobacterium paratuberculosis antibodies in a biological sample.

Abstract: The invention provides processes for improving the ability of a peptide to stimulate an immune response, comprising exposing the peptide to a chemical modifying agent. It further provides compositions comprising an antigenic peptide, wherein the peptide has been treated with a chemical modifying agent to improve its ability to stimulate an immune response. It also provides methods of stimulating an immune response in a mammal, comprising administering to the mammal an effective amount of a vaccine.

Abstract: Described herein are microorganisms that are modified so that they have an increased ability to be recognized by the innate immune system of a eukaryote, relative to an unmodified microorganism. A microorganism may be a gram-negative bacterium that has been modified to produce high potency lipopolysaccharide, e.g., Yersinia pestis expressing LpxL. Such modified microorganisms may be used as vaccines for protection against an infection by the unmodified microorganism. They may also be used as delivery vehicles of one or more heterologous antigens, e.g., antigens from pathogens or those associated with a hyperproliferative eukaryotic cell.

Abstract: The present invention relates to a malleable protein matrix (MPM), which is the reaction product of the agglomeration of proteins after a fermentation process and is exhibiting biological activities and is suitable for the incorporation (or encapsulation) of various hydrophilic or lipophylic substances. The present invention also relates to the process for the preparation of the malleable protein matrix and its usages.

Abstract: Probiotic Bifidobacterium strain AH1205 or mutants or variants thereof are immunomodulatory following oral consumption and are useful in the prophylaxis and/or treatment of inflammatory activity such as undesirable gastrointestinal inflammatory activity for example inflammatory bowel disease.

Abstract: The present invention provides methods and compositions for the stimulation of immune responses. Specifically, the present invention provides methods of inducing an immune response against one or a plurality of pathogens (e.g., vaccinia virus, H5N1 influenza virus, Bacillus anthracis, C. botulinum, Y. pestis, Hepatitis B, and/or HIV, etc.) in a subject (e.g., a human subject) and compositions useful in such methods (e.g., immunogenic composition comprising nanoemulsion and one or a plurality of pathogens (e.g., inactivated by the nanoemulsion) and/or pathogen products and/or pathogen components). Compositions and methods of the present invention find use in, among other things, clinical (e.g. therapeutic and preventative medicine (e.g., vaccination)) and research applications.

Abstract: An accelerating agent for elimination of dioxins which comprises, as an active ingredient, a microorganism having an activity of accelerating elimination of dioxins in the body to the outside of the body.

Abstract: A composition comprising a drug or pharmaceutically active agent and a bioadhesive delivery system provides for the oral delivery of a vaccine to animals, particularly aquatic animals.

Abstract: Provided is a strain of exopolysaccharide-secreting Lactobacillus plantarum and an application thereof. The deposit number of the strain is CGMCC No. 5222. The strain differs from other strains of Lactobacillus plantarum in the amount of exopolysaccharide secreted, has unique physiological and biochemical characteristics and genetic background, and is a newly isolated and identified strain of Lactobacillus plantarum.

Abstract: The invention relates to generation and use of cellular and humoral responses for the prevention and treatment of P. gingivalis related conditions and diseases.

Abstract: The use of flagellin and flagellin related polypeptides for the protection of mammals from the effects of apoptsis is described.

Abstract: The present invention relates to an isolated Clostridial neurotoxin propeptide having a light chain region, a heavy chain region, where the light and heavy chain regions are linked by a disulfide bond, and an intermediate region connecting the light and heavy chain regions. An isolated nucleic acid molecule encoding a Clostridial neurotoxin propeptide is also disclosed. Also disclosed is an isolated, physiologically active Clostridial neurotoxin produced by cleaving a Clostridial neurotoxin propeptide, a vaccine or antidote thereof, and methods of immunizing against or treating for toxic effects of Clostridial neurotoxins. Methods of expressing recombinant physiologically active Clostridial neurotoxins are also disclosed. Also disclosed is a chimeric protein having a heavy chain region of a Clostridial neurotoxin and a protein with therapeutic functionality. A treatment method is also disclosed.

Abstract: Compounds and methods are provided for diagnosing, preventing, treating and detecting leishmaniasis infection and stimulating immune responses in patients are disclosed. The compounds disclosed are include polypeptides and fusion proteins that contain at least one immunogenic portion of one or more Leishmania antigens, or a variant thereof. Additionally, methods of screening a screening library for tandem repeat proteins that have immunogenic properties are disclosed. Vaccines and pharmaceutical compositions comprising polynucleotides, polypeptides, fusion proteins and variants thereof that may be used for the prevention and therapy of leishmaniasis, as well as for the detection of Leishmaniasis infection are described.

Abstract: Provided is a pharmaceutical composition including dead cells of Lactobacillus acidophilus LB strain as an active ingredient for treating or preventing an allergic disease, and may be used to treat and prevent IgE-mediated allergic diseases and non-IgE-mediated allergic diseases such as atopic dermatitis, allergic rhinitis, allergic conjunctivitis, urticaria, and pollinosis by reducing the total content of IgE in the blood.

Abstract: The invention provides mutants of GAS57 (Spy0416) which are unable to cleave IL-8 and similar substrates but which still maintain the ability to induce protection against S. pyogenes. The invention also provides antibodies which specifically bind to GAS57 and which inhibit its ability to cleave IL-8 and similar substrates. The mutants are useful, inter alia, in vaccine compositions to induce protection against S. pyogenes. The antibodies are useful, e.g., as therapeutics for treating S. pyogenes infections.

Abstract: The invention provides live, attenuated enterohemorrhagic Escherichia coli (EHEC) bacteria in which the Shiga toxin coding sequences are deleted to abolish Shiga toxin production and one or more of the nucleotide sequences for the bacterial adhesin protein intimin, the locus of enterocyte effacement encoded regulator, and the translocated intimin receptor are mutated to inactivate the activity of the encoded protein(s). This live, attenuated E. coli bacteria is used in a vaccine for reducing or inhibiting carriage and shedding of EHEC in cattle.

Abstract: The present invention pertains to microorganisms of the species Bacteroides xylanisolvens expressing a core-1 antigen on their surface. These microorganisms are in particular useful for the prophylaxis and treatment of core-1 positive diseases and are particularly characterized by a stable, homogenous high core-1 expression. Also provided are pharmaceutical compositions which comprise respective core-1 positive microorganisms or fractions thereof.

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: Described herein are methods and compositions for expressing an antibody or a fragment thereof in a microorganism and use of the microorganism to treat or prevent a pathogenic infection in a mammal.

Abstract: Vaccines for conferring immunity in mammals to infective pathogens are provided, as well as vectors and methods for plastid transformation of plants to produce protective antigens and vaccines for oral delivery. The invention further provides transformed plastids having the ability to survive selection in both the light and the dark, at different developmental stages by using genes coding for two different enzymes capable of detoxifying the same selectable marker, driven by regulatory signals that are functional in proplastids as well as in mature chloroplasts. The invention utilizes antibiotic-free selectable markers to provide edible vaccines for conferring immunity to a mammal against Bacillus anthracis, as well as Yersina pestis. The vaccines are operative by parenteral administration as well. The invention also extends to the transformed plants, plant parts, and seeds and progeny thereof. The invention is applicable to monocot and dicot plants.

Abstract: The present application discloses an improved method for conducting saccharide—protein conjugation reactions using carbodiimide condensation chemistry. Depending on the nature of the saccharide or protein carrier involved, the quality of the conjugate may be improved by adding one of the reaction components slowly to the reaction mixture. Immunogenic compositions are further provided comprising the saccharide-protein conjugates made by the methods disclosed.

Abstract: Provided herein are methods and compositions for stabilization of active agents. The active agents are distributed, mixed or embedded in a silk fibroin matrix, thereby retaining the bioactivity of the active agents upon storage and/or transportation. In some embodiments, the storage-stable vaccine-silk compositions are also provided herein.

Abstract: The invention relates to Gram-negative bacteria carrying an inactivated gene encoding a glycosyltransferase involved in the synthesis of the core of the LPS of said Gram-negative bacteria, wherein said inactivated gene results in the synthesis of a LPS having a modified core. These strains have an attenuated virulence but induce a humoral immunity sufficient for ensuring vaccination of the host.

Abstract: The subject technology relates generally to compositions and methods for producing plasmid DNA of a desired quality. In addition, it relates to the discovery of Escherichia coli (E. coli) bacteria with a constitutive methylase gene stably incorporated into the chromosomal DNA and uses thereof.

Abstract: It is disclosed herein that treatment of a subject with an mTOR inhibitor enhances antigen-specific T cell immune responses. Thus, provided herein is a method of enhancing an antigen-specific T cell response in a subject by administering to the subject a therapeutically effective amount of an mTOR inhibitor. The antigen can be any antigen, such as an antigen from a pathogen or a vaccine, or a tumor antigen. In some embodiments, the method further comprises administering to the subject a vaccine, such as a virus vaccine or a cancer vaccine. The mTOR inhibitor can be administered either before or after vaccination to enhance the quantity and quality of the T cell immune response and immunological memory. In some examples, the mTOR inhibitor is rapamycin or a rapamycin analog.

Abstract: Embodiments of the invention include methods and compositions useful in a vaccination strategy capable of neutralizing HIa to provide immunoprotection against S. aureus pneumonia. In certain aspects the invention includes a HIa with reduced toxicity, represented by a recombinant mutant form of HIa (HlaH35L) in which histidine 35 is converted to leucine, which can be used to abrogate the productive assembly of the toxin and protect a subject from staphylococcal pneumonia.

Abstract: The subject invention provides compositions for alleviating type 1 diabetes (T1D). In preferred embodiments, the compositions comprise an effective amount of one or more antigen presenting cells (APCs) that have been pulsed with one or more bacterial isolates and/or compounds from the isolates. The bacteria used to pulse the APCs are, preferably, those that confer upon the APCs the ability to inhibit the generation of diabetes-promoting T cells. In specific embodiments, these bacteria may be, for example, Eubacteria or Clostridia. In a preferred embodiment, the APCs are dendritic cells (DCs).

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: The present invention relates to coated dehydrated microorganisms comprising a dehydrated microorganism surrounded by at least one coating, said coating comprising by dry weight at least 25% of hygroscopic salt(s) and wherein the pH of the coating is compatible with viability of the coated dehydrated microorganism. The coating can be partially crystalline, the salt(s) in the coating having preferably a crystallinity degree of up to 60% once applied onto the dehydrated microorganism. The present invention also relates to liquid coating compositions, methods for coating and protecting a dehydrated microorganism. Finally, the present invention relates to a method for the preparation of food products, feed products, consumer healthcare products or agri-products as well as to a food product, feed product, a consumer healthcare product or an agri-product containing such coated dehydrated microorgansims.

Abstract: A pharmaceutical composition for treating or preventing a Th2-mediated disease or disorder includes live, killed or attentuated Franciscella tularensis or its components. The F. tularensis cells may be LVS cells. Administration of an effective amount may prevent or reduce bronchoconstriction or allergic airway inflammation through a T-helper cell (Th) 1-mediated suppression of an ongoing Th2 response mechanism.

Abstract: Methods and compositions are provided herein for immunizing a subject by administering to the subject an effective amount of an immunogenic peptide or an immunogenic fragment or variant thereof incorporated within a vault-like particle carrier. The methods and compositions advantageously exhibit enhanced ability to induce cell-mediated immunity and/or antibody-based immunity.

Abstract: Factor H binding protein (fHBP) has been proposed for use in immunising against serogroup B meningococcus (‘MenB’). This antigen can be efficiently adsorbed to an aluminium hydroxyphosphate adjuvant by (i) ensuring that adsorption takes place at a pH which is equal to or below the adjuvant's point of zero charge (PZC), and/or (ii) selecting a fHBP and adjuvant with an isoelectric point/PZC within the range of 5.0 to 7, and/or (iii) selecting a fHBP with an isoelectric point above the adjuvant's PZC and using a buffer to bring the pH to within 1.2 pH units of the PZC. The adsorption is particularly useful for compositions which include multiple fHBP variants, and also in situations where an aluminium hydroxide adjuvant should be avoided. Buffered pharmaceutical compositions can include at least two different meningococcal fHBP antigens, both of which are at least 85% adsorbed to aluminium hydroxyphosphate adjuvant.

Abstract: Methods of using tetanus toxin to modulate or control neural functions or nonneural cellular activities at selected sites in animals, particularly in mammals, and more particularly in humans, are provided. Pharmaceutical formulations to modulate neural functions or non-neural cellular activities of an animal at selected sites in animals, particularly in mammals, and more particularly in humans are also provided. Uses of tetanus toxin in preparation of medicaments for methods of treating clinical disorders or symptoms of animals, particularly mammals and more particularly humans are also provided.

Abstract: This invention relates to therapeutic polynucleotide compositions and methods for systemic immune activation which are effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in mammals. The polynucleotide compositions are particularly effective for protecting mammals from herpes simplex virus (HSV), such as HSV VP13/14 polypeptides.

Abstract: The disclosure relates to a composition added to animal feed used in combination with a vaccine to enhance the effectiveness of the vaccine. Amongst other effects, the composition raises the titer of antibodies to the vaccine.

Abstract: A composition comprising liposomes associated with a nucleic acid operatively encoding an antigenic protein and with an assistor protein, wherein the assistor protein shares at least one epitope with the antigenic protein, and wherein the nucleic acid and said assistor protein are associated with the same liposomes is described. The composition provides an improved immune response compared to mixtures of liposomes some of which are associated with the nucleic acid and some of which are associated with the assistor protein.

Abstract: Adjuvant and immunological vaccine compositions comprising modified, cationic metal oxides are disclosed, including methods of making modified, cationic metal oxides and methods of using the modified metal oxides in vaccine formulations and regimens.

Abstract: A liposomal composition, preferably a vaccine, comprising liposomes formed of liposome forming compounds, containing coentrapped polysaccharide antigen and T-cell dependent protein carrier, such as tetanus toxoid or diphtheria toxin modified to render it non-toxic. The invention is of use in the production of vaccines against Haemophilus influenzae, Streptococcus pneumoniae or Neisseria meningitidis.

Abstract: A combination of CpG oligonucleotides and polymer microparticles is an extremely effective adjuvant for Neisserial antigens. The invention therefore provides a composition comprising: (a) a Neisserial antigen; (b) a CpG oligonucleotide; and (c) a biodegradable polymer microparticle.