Abstract: Disclosed are synthetic nanocarrier compositions, and related methods, comprising CD1d-restricted antigens and immunosuppressants that provide tolerogenic immune responses.

Abstract: The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated form of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.

Abstract: The present invention relates to the fields of microbiology and vaccine technology, and concerns the development of a vaccine capable of conferring immunity to group B Streptococcus infections. More particularly, the present invention relates to a novel fusion protein, comprising N-terminal region fragments of group B Streptococcus surface proteins, which confers immunity to invasive strains of the group B Streptococcus. It further pertains to an isolated nucleotide sequence encoding said fusion protein; a vector; a host cell; a vaccine; and a method for preventing or treating a group B Streptococcus infection.

Abstract: The present invention relates to enterococcal cell wall components and their uses in the prevention and therapy of bacterial infection.

Abstract: The present invention relates to immunogenic conjugates comprising S. aureus serotype 5 and 8 capsular polysaccharides conjugated to carrier proteins and methods for their preparation and use. Methods for making the immunogenic conjugates of the invention involve covalent conjugation of the capsular polysaccharides with the carrier proteins using conjugation chemistry involving either 1,1-carboyl-di-1,2,4-triazole (CDT) or 3-(2-pyridyldithio)-propionyl hydrazide (PDPH).

Abstract: The present specification discloses TEMs, compositions comprising such TEMs, compositions comprising such TEMs and Clostridial toxins, methods of treating a vagal nerve-based disorder in an individual using such compositions, use of such TEMs in manufacturing a medicament for treating a vagal nerve-based disorder, use of such TEMs and Clostridial toxins in manufacturing a medicament for treating a vagal nerve-based disorder, use of such TEMs in treating a vagal nerve-based disorder, and use of such TEMs and Clostridial toxins in treating a vagal nerve-based disorder.

Abstract: Compositions and methods are provided that are useful to treat respiratory diseases such as whooping cough. Further, compositions and methods of immunizing are provided.

Abstract: An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated to a carrier protein. The immunogenic composition, formulated as a vaccine, increases coverage against pneumococcal disease in infants and young children globally, and provides coverage for serotypes 6A and 19A that is not dependent on the limitations of serogroup cross-protection.

Abstract: GPC (gel permeation chromatography) and size exclusion chromatography with detection by multi-angle light-scattering photometry (SEC-MALS) can be used to accurately measure molecular size and molar mass, respectively, of saccharide conjugates. The invention provides (a) a process for measuring the molecular size of a conjugated saccharide antigen within a sample, comprising a step of analysing the sample by GPC, and (b) a process for measuring the molar mass of a conjugated saccharide antigen within a sample, comprising a step of analysing the sample by SEC-MALS.

Abstract: The present invention relates to immunogenic compositions comprising capsular polysaccharide or oligosaccharide of H. influenzae B (PRP) and methods of making such compositions.

Abstract: The present invention is in the field of pneumococcal capsular saccharide conjugate vaccines. Specifically, a multivalent Streptococcus pneumoniae immunogenic composition is provided with various (for instance 9 or more) conjugated capsular saccharides from different S. pneumoniae serotypes, wherein the composition comprises conjugated capsular saccharide 18C which is less than 80, 70, 60, 50, 40, 30, 20, 15 or 10% O-Acetylated.

Abstract: Disclosed herein are compositions for the treatment of a disease in an animal including yeast extract of Saccharomyces cerevisiae, Bacillus licheniformis or Bacillus subtilis spores, and a carrier. Also included are animal feed compositions including the composition for the prevention, control and/or treatment of a disease in an animal and an animal's food/feed. The compositions are useful to prevent, control, and treat diseases such as necrotic enteritis in poultry when used in combination with an anticoccidal ionophore or coccidiosis vaccine.

Abstract: The present invention provides methods for the treatment or prevention of allergic airways diseases, the suppression of allergic immune responses, and the induction protective immunity against allergic airways diseases wherein the methods comprise administering to subjects in need thereof an effective amount of a Streptococcus pneumoniae capsular polysaccharide and a Streptococcus pneumoniae exotoxin or exotoxoid, optionally together with one or more additional antigenic or immunomodulatory constituents, components or fractions of Streptococcus pneumoniae and/or immunopotentiators. Administration of individual components is also contemplated. Also provided are vaccine compositions suitable for use in accordance with methods disclosed herein.

Abstract: The present invention relates to the field of neisserial vaccine compositions, their manufacture, and the use of such compositions in medicine. More particularly it relates to processes of making novel engineered meningococcal strains which are more suitable for the production of neisserial, in particular meningococcal, outer-membrane vesicle (or bleb) vaccines. Advantageous processes and vaccine products are also described based on the use of novel LOS subunit or meningococcal outer-membrane vesicle (or bleb) vaccines which have been rendered safer and/or more effective for use in human subjects. In particular combinations of gene downregulations are described such as PorA and OpA, PorA and OpC, OpA and OpC, and PorA and OpA and OpC. Alternatively, or in addition, lgtB? is shown to be an optimal mutation for effectively and safely using L3 and/or L2 LOS in Neisseria vaccine compositions.

Abstract: The invention provides conjugates comprising an immune co-stimulatory polypeptide and an antigen or infectious agent. The conjugates are useful for generating or enhancing an immune response against the antigen or infectious agent. The invention also provides immune cells modified with a conjugate that are useful for generating or enhancing an immune response to an antigen or infectious agent. The invention also provides immunostimulatory moieties comprising an immune co-stimulatory polypeptide that are useful for stimulating an immune response. The invention also provides immunotherapy methods and methods of treating or preventing infections.

Abstract: The invention is based on methods that allow analysis of mixed meningococcal saccharides from multiple serogroups even though they share monosaccharide units. With a combination of saccharides from serogroups C, W135 and Y, the invention analyses sialic acid, glucose and galactose content. The glucose and galactose results are used to directly quantify saccharides from serogroups Y and W135, respectively, and the combined glucose and galactose content is subtracted from the sialic acid content to quantify saccharides from serogroup C. The three serogroups can thus be resolved even though their monosaccharide contents overlap. The three different monosaccharide analyses can be performed on the same material, without interference between the monosaccharides and without interference from any other saccharide materials in the composition (e.g. lyophilisation stabilisers).

Abstract: Helicobacter pylori, one of the most common human pathogens, is associated with the development of human chronic gastritis, peptic ulcers and gastric cancer. The invention relates to a ?1,6-glucan-containing Helicobacter pylori compound comprising the structure of Formula (I): wherein R is a ?-DDHep-3-?-L-Fuc-3-?-GlcNAc trisaccharide substituted with an ?1,6-glucan linked to an ?1,3-DD-heptan, and wherein the last DD-Hep residue of ?1,3-DD-heptan is capped with ?-GlcNAc residue. Compositions comprising the compound, uses of the compound, and antibodies raised against the compound are also described.

Abstract: The present invention is directed to methods and compositions for the treatment and diagnosis of neuroectodermally-derived tumors, such as gliomas. The inventive methods of treatment generally include local (e.g., intracavitary) administration of a chloroxotoxin moiety conjugated to a cytotoxic moiety to a patient. Also provided are diagnostic methods for screening neoplastic neuroectodermal tumors.

Abstract: This invention relates to conjugates of the Vi polysaccharide of S. typhi with the carrier Pseudomonas aeruginosa recombinant exoprotein A (rEPA), and compositions thereof, and to methods of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of, S. typhi bacterial infections. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies against S. typhi and are useful to prevent and/or treat illnesses caused by S. typhi.

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: The present invention provides a multivalent immunogenic composition having 15 distinct polysaccharide-protein conjugates. Each conjugate consists of a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F or 33F) conjugated to a carrier protein, preferably CRM197. The immunogenic composition, preferably formulated as a vaccine on an aluminum -based adjuvant, provides broad coverage against pneumococcal disease, particularly in infants and young children.

Abstract: This invention is directed to processes for reducing the level of free carbohydrate from a solution of protein-linked carbohydrate (conjugate) and non-linked carbohydrate. In this process, the conjugate is adsorbed to a hydrophobic membrane while the carbohydrate is not. The conjugate is then desorbed from the membrane, yielding a solution that is substantially reduced in free carbohydrate.

Abstract: The present invention pertains to a vaccine directed against porcine pleuropneumonia, comprising lipopolysaccharide, wherein the vaccine comprises a polymyxin to reduce symptoms of an endotoxic shock arising from the lipopolysaccharide. The invention also pertains to a method to obtain such a vaccine and a method for administering the vaccine to a subject animal.

Abstract: Calcium phosphate is used as an adjuvant, with a high degree of antigen adsorption to the adjuvant. The invention is particularly useful for adjuvanting conjugated capsular saccharide antigens. Buffers, such as phosphate or histidine buffers, can advantageously be used in combination with the calcium phosphate, and compositions may have a pH in the range of 5.5 to 7.5.

Abstract: The present invention provides recombinant Listeria strains comprising an angiogenic factor, recombinant polypeptides comprising an angiogenic factor operatively linked to a polypeptide comprising a PEST-like sequence, recombinant nucleotide molecules encoding same, related vaccines, and immunogenic and therapeutic methods utilizing same.

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: Methods for preparing complex multivalent immunogenic conjugates that include simultaneously reacting a plurality or immunogenic-distinct polysaccharides with at least one protein to make the complex multivalent immunogenic conjugates. The simultaneous reaction involves reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant.

Abstract: An effective Staphylococcus aureus vaccine may require several antigenic components, and so various combinations of S. aureus antigens are identified for use in immunisation. These polypeptides may optionally be used in combination with S. aureus saccharides.

Abstract: When preparing HBsAg for use in a combination vaccine, it us known to add a non-ionic detergent after the HBsAg has been purified. Adding detergents after purification of HBsAg is not optimal, however, as it requires a separate processing step during manufacture. Thus the invention uses them during HBsAg purification.

Abstract: The present invention relates to immunogenic compositions, comprising polypeptides and polysaccharides from Staphylococcus aureus. The present invention also relates to immunogenic compositions, comprising Staphylococcus aureus capsule polysaccharides conjugated to a carrier protein. In addition, the invention relates to methods of inducing an immune response in subjects against Staphylococcus aureus using immunogenic compositions of the Staphylococcus aureus polypeptides and capsule polysaccharides.

Abstract: Provided herein are combination vaccines comprising antigens for protecting a subject against at least diphtheria, tetanus, pertussis and Hib, wherein: (a) the antigen for protecting against Hib is a conjugate of a Hib capsular saccharide; (b) the concentration of the Hib conjugate in the vaccine is <15 ?g/ml; and (c) the Hib conjugate has never been lyophilised.

Abstract: This invention relates to conjugates of the O-specific polysaccharide of E. coli O157 with a carrier, and compositions thereof, and to methods of using of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in mammals, including responses which provide protection against, or reduce the severity of, bacterial infections. More particularly it relates to the use of polysaccharides containing the tetrasaccharide repeat unit: (?3)-?-DGalpNAc-(1?2)-?-D-PerpNAc-(1?3)-?-L-Fucp-(1?4)-?-D-Glcp-(1?), and conjugates thereof, to induce serum antibodies having bactericidal (killing) activity against hemolytic-uremic syndrome (HUS) causing E. coli, in particular E. coli O157. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies which have bactericidal or bacteriostatic activity against E. coli, in particular E. coli O157, and are useful to prevent and/or treat illnesses caused by E. coli O157.

Abstract: The present invention relates to protein antigens IcsP2 and SigA2 from Shigella that are common among numerous Shigella types and species and which can protect against shigellosis or other enteric infections when administered as vaccines. In addition, the present invention relates to antigens that are in common between Shigella species and enteroinvasive Escherichia coli (EIEC). The invention also relates to the use of antibodies raised against these antigens and of DNA probes for use in the diagnosis of Shigella and EIEC infections.

Abstract: An objective of the invention is to provide a drug delivery vehicle capable of allowing a vaccine or adjuvant to reach a target cell or tissue efficiently while being capable of improving the immunogenicity of the vaccine or capable of enhancing the immunostimulating effect of the adjuvant as well as a vaccine or adjuvant utilizing the same. Said drug delivery vehicle contains a multimeric protein having a coiled coil structure and a ligand molecule to a receptor of an immune cell.

Abstract: Staphylococcus aureus Hla polypeptides having various deletions, insertions, and/or mutations which are useful for immunisation are provided herein. Also provided herein are Hla heptamers which are non-haemolytic. Additionally, an effective Staphylococcus aureus vaccine may require several antigenic components, and so various combinations of S. aureus antigens, including Hla polypeptides having deletions, insertions, and/or mutations, are identified for use in immunisation. These polypeptides may optionally be used in combination with S. aureus saccharides.

Abstract: The invention provides an immunogenic composition comprising at least one antigen in association with microparticles, wherein the microparticles are in the same size range as viruses. In addition the invention also provides vaccine compositions and methods of eliciting immune responses in a subject.

Abstract: The present invention relates to protein antigens IcsP2 and SigA2 from Shigella that are common among numerous Shigella types and species and which can protect against shigellosis or other enteric infections when administered as vaccines. In addition, the present invention relates to antigens that are in common between Shigella species and enteroinvasive Escherichia coli (EIEC). The invention also relates to the use of antibodies raised against these antigens and of DNA probes for use in the diagnosis of Shigella and EIEC infections.

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: The present invention provides BoNT/A peptides as well as methods of predicting or determining immunoresistance to botulinum toxin therapy in an individual using BoNT/A peptides.

Abstract: Meningococcal lipooligosaccharide and pneumococcal serotype 14 capsular saccharide share an antigen that can cross-react with human tissue. The invention provides various ways of minimising the production of autoreactive antibodies when these two antigens are co-administered.

Abstract: This invention provides novel nitrocellulose-based or Hydrogel-based microarrays and methods of making and using them (1) to detect the presence of one or more agents in a sample, (2) to determine the amount of one or more agents in a sample, (3) to determine whether a subject is afflicted with a disorder, and (4) to determine whether an agent known to specifically bind to a first compound also specifically binds to a second compound. This invention also provides kits which comprise the instant microarrays. This invention further provides antibodies capable of specifically binding to a glycomer present both on the surface of a mammalian macrophage or intestinal epithelial cell, and on a bacterial cell. Finally, this invention provides diagnostic methods using the instant antibodies.

Abstract: The present invention provides an immunogenic conjugate comprising biologically deacylated gram-negative bacterial moieties linked to D. discoideum proteinase 1, as well as novel subunits thereof, and methods of making and using the conjugates in vaccines to treat sepsis and other infectious complications.

Abstract: An immunogenic composition comprising a siderophore covalently linked to a pharmaceutically acceptable carrier molecule wherein the antigenicity of the siderophore moiety is sufficient to stimulate an immuno-logic response to the siderophore when the composition is circulating in the bloodstream of a human or non-human animal and vaccine.

Abstract: The present invention relates to new pneumococcal vaccines. The invention also relates to vaccination of subjects, in particular immunocompromised subjects, against pneumococcal infections using said novel pneumococcal vaccines.

Abstract: A glycolipopeptide comprising a carbohydrate component, a peptide component and a lipid component, for use as a therapeutic or prophylactic vaccine. Also provided are monoclonal and polyclonal antibodies that recognize the glycolipopeptide of the invention, as well as uses thereof.

Abstract: The present invention relates to Neisseria ORF2086 proteins, crossreactive immunogenic proteins which can be isolated from nesserial strains or prepared recombinantly, including immunogenic portions thereof, biological equivalents thereof, antibodies that immunospecifically bind to the foregoing and nucleic acid sequences encoding each of the foregoing, as well as the use of same in immunogenic compositions that are effective against infection by Neisseria meningitidis serogroup B.

Abstract: The present invention provides methods of immunizing a subject against a tumor, inhibiting tumor growth, inhibiting tumor recurrence, treating, suppressing the growth of, or decreasing the incidence of a tumor, overcoming tolerance to a tumor vasculature marker (TVM) in a subject comprising the step of administering a vaccine comprising a TVM or a nucleic acid encoding a TVM and related vaccines. The present invention also provides a method of targeting a tumor vasculature in a subject having a tumor comprising the step of contacting said subject with a labeled compound that binds a) a tumor vasculature marker (TVM) or b) a nucleic acid molecule encoding said TVM.

Abstract: The present invention is drawn to a live, attenuated S. Paratyphi A strain, a live, attenuated S. Paratyphi A strain comprising a stabilized plasmid expression system, an S. Paratyphi conjugate vaccine, and methods of using these strains and conjugate vaccine.

Abstract: Methods for producing an immune response to Mycobacterium tuberculosis (Mtb) are disclosed herein. In several examples, the immune response is a protective immune response. In additional embodiments, methods are disclosed for preventing an infection with Mtb, or treating an infection with Mtb. Pharmaceutical compositions for the prevention and/or treatment of tuberculosis are also disclosed.

Abstract: This disclosure relates to vaccine formulations comprising an immunogenic composition for inducing antibodies to both S. pneumoniae and N. meningitides in a subject. In a preferred aspect, the immunogenic composition comprises covalently conjugated recombinant PsaA (“rPsaA”) from S. pneumoniae and capsular polysaccharide from N. meningitidis serogroup C. This disclosure further relates to methods for producing the immunogenic composition as well as methods for their use.