Abstract: The present invention provides Chlamydia proteins and compositions and methods of use in the treatment/prevention of chlamydial infection in a subject, for eliciting an immune response in a subject and for reducing the likelihood of infertility and reducing the incidence and/or degree of hydrosalpinx due to Chlamydia infection in a subject.

Abstract: A liquid D-T-Pa component is used to reconstitute a lyophilised meningococcal component, thereby producing a combined vaccine.

Abstract: The present invention relates to a method for purifying bacterial cytolysins such as pneumococcal pneumolysin. A single chromatography step produces excellent purification of the cytolysin by binding soluble aggregated cytolysin to a hydrophobic interaction chromatography material in the presence of detergent and high salt.

Abstract: Various improvements to vaccines that include a serogroup C meningococcal conjugate antigen, including: (a) co-administration with acellular B. pertussis antigen; (b) co-administration with an inactivated poliovirus antigen; (c) supply in a kit together with a separate pneumococcal conjugate component, which may be in a liquid form; and (d) use in combination with a pneumococcal conjugate antigen but without an aluminium phosphate adjuvant. A kit may have: (a) a first immunogenic component that comprises an aqueous formulation of a conjugated capsular saccharide from Streptococcus pneumoniae; and (b) a second immunogenic component that comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C.

Abstract: An aqueous immunogen formulation is used to reconstitute a lyophilised component including conjugates of capsular saccharides from Neisseria meningitidis serogroups A, C, W135 and Y, thereby producing a combined vaccine. The aqueous formulation can include various immunogens but does not include a Hib conjugate.

Abstract: Provided herein is a method for chemically programmed vaccination. Methods include inducing a covalent-binding polyclonal antibody response in a subject and programming the polyclonal response with a targeting compound.

Abstract: The present invention relates to methods and compositions for the treatment and prevention of diarrhea and diarrheal related diseases and disorders in both animals and humans. In some embodiments, the invention relates to the treatment of said diarrhea and diarrheal related diseases and disorders with a vaccine. In still further embodiments, the invention relates to the treatment of constipation using the disclosed methods and compositions.

Abstract: Immunogenic compositions, and method of using the compositions to elicit an immune response against Campylobacter jejuni. The compositions are isolated polysaccharide polymers derived from Campylobacter jejuni capsule.

Abstract: The invention relates to the finding that stimulation of antigen presenting cell (APC) activation using substances such as anti-CD40 antibodies or DNA oligomers rich in non-methylated C and G (CpGs) can dramatically enhance the specific T cell response obtained after vaccination with recombinant virus like particles (VLPs) coupled, fused or otherwise attached to antigens. While vaccination with recombinant VLPs fused to a cytotoxic T cell (CTL) epitope of lymphocytic choriomeningitis virus induced low levels cytolytic activity only and did not induce efficient anti-viral protection, VLPs injected together with anti-CD40 antibodies or CpGs induced strong CTL activity and full anti-viral protection. Thus, stimulation of APC-activation through antigen presenting cell activators such as anti-CD40 antibodies or CpGs can exhibit a potent adjuvant effect for vaccination with VLPs coupled, fused or attached otherwise to antigens.

Abstract: Active immunotherapy methods for treating a human patient having an amyloid disease characterized by the presence of amyloid fibrils comprising islet amyloid polypeptide (IAPP).

Abstract: An oligosaccharide useful for a Meningitidis A vaccine contains a first mannose unit having a spacer in the alpha configuration at C-1, which spacer is capable of conjugating to a protein, and which is connected to a second mannose unit through a 1,6-linkage which connects C-6 of the first unit to C-1 of the second unit, wherein the 1,6-linkage comprises a phosphonate. Related methods of making such compounds, analogous compounds, or intermediates thereof are also disclosed.

Abstract: A detoxified recombinant E. coli heat-labile enterotoxin mutant, LTS61K, is employed as a carrier protein to conjugate polysaccharide. The LTS61K contains a mutated mature sub-unit A (LTA) that includes lysine at amino acid position 61 and a wild-type mature sub-unit B (LTB). Various types of bacterial capsular polysaccharide antigens were chemically conjugated with the LTS61K protein by a reductive amination reaction. The conjugated polysaccharide-LTS61K products were physically, chemically and biochemically identified as soluble form. Rabbits were immunized intramuscularly to determine the immunogenicity of conjugated vaccines by ELISA to detect anti-polysaccharide antigen IgG titers and serum bactericidal assay thereby determining the functional activity of the antibodies. Study results show that conjugated polysaccharide-LTS61K vaccines induce higher polysaccharide-specific IgG titers and greater bactericidal activity in sera than that of polysaccharide alone or polysaccharide mixed with LTS61K.

Abstract: The present invention is drawn to attenuated Salmonella serovar strains S. Typhimurium and S. Enteritidis, conjugate vaccines derived from these attenuated strains of S. Typhimurium and S. Enteritidis, comprising an O polysaccharide covalently linked to a flagellin protein, and methods for inducing an immune response in a subject comprising administering the attenuated strains and/or the conjugate vaccines of the invention.

Abstract: The present invention concerns methods and compositions for treating or preventing a bacterial infection, particularly infection by a Staphylococcus bacterium. The invention provides methods and compositions for stimulating an immune response against the bacteria. In certain embodiments, the methods and compositions involve an Eap, Emp and/or AdsA amino acid sequence, or an agent that binds and inhibits the same.

Abstract: The present invention relates to methods and compositions for treatment of microbial infections and for the enhancement of resistance to infection. The invention comprises administration of an effective amount of a protein isolated from bacterial lysate compositions for the treatment of pathological conditions of microbial infections. The present invention can also be used to enhance the immune system to prevent infections by the administration of an effective amount of the compositions.

Abstract: Anthrax vaccine compositions comprise a segment of a PA toxin protein that stimulates a B cell immune response specific for a defined epitope on the protective antigen of B. anthracis, a pharmaceutical excipient and optionally, one or more other protein segments comprising epitopes that augment the B cell response by stimulating a T cell immune response. The pharmaceutical compositions are useful for vaccinating individuals so as to confer protection from disease caused by B. anthracis including anthrax disease resulting from anthrax spore inhalation.

Abstract: The efficient synthesis of phosphatidylinositol mono- to hexa-mannoside (PIM1 to PIM6) is reported. The invention relates to these phosphatidylinositol mono- to hexa-mannosides carrying a linker and a reactive functional group, e.g. the sulfhydryl group, a protein, a fluorescent probe, or a solid phase.

Abstract: The present invention provides compositions and methods for augmenting vaccine immunogenicity using mucin-immunoglobulin fusion proteins.

Abstract: The invention provides improved agents and methods for treatment of diseases associated with amyloid deposits of A? in the brain of a patient. Such methods entail administering agents that induce a beneficial immunogenic response against the amyloid deposit. The methods are useful for prophylactic and therapeutic treatment of Alzheimer's disease. Preferred agents including N-terminal fragments of A? and antibodies binding to the same.

Abstract: An object of the present invention is to provide a peptide vaccine for preventing and/or treating diseases caused by amyloid ?-peptide, such as Alzheimer's disease. The present invention solves the above object by providing a peptide vaccine constructed by inserting a peptide having an amino acid sequence of a cell attachment motif of a cell adhesive molecule to a peptide which consists of a peptide having an amino acid sequence of multiagretope type T-cell epitope, which has been generated immunological memory, or a peptide including the same; an linker peptide; and a peptide having an amino acid sequence of a B cell epitope which is a specific region of amyloid ?-peptide or a peptide including the same.

Abstract: Disclosed herein are various combinations of pneumococcal polypeptides for use in immunisation. Also disclosed herein are pneumococcal polypeptides that may be useful as single antigens. These polypeptides may optionally be used in combination with pneumococcal saccharides. The antigens may be used in pneumococcal vaccines, but may also be used as components in vaccines for immunising against multiple pathogens.

Abstract: The invention concerns a pharmaceutical composition for treating or preventing a certain number of infections caused by pathogenic agents such as bacteria, comprising as immunogen, one or several polyosides derived from one or several pathogenic agents. The polyosides are in the form of conjugates, coupled with a carrier protein. The composition contains at least two types of conjugates, each being at least characterised by a different protein carrier.

Abstract: The present invention relates to improved bacterial polysaccharide-polypeptide conjugate compositions, pharmaceutical compositions comprising such bacterial polysaccharide-polypeptide conjugate compositions, and the use of such compositions. Furthermore, the invention relates to the use of a combination of a peptide of the formula R1—XZXZNXZX—R2 and an immunostimulatory deoxynucleic acid containing deoxyinosine and/or deoxyuridine residues. The present invention also provides methods for the prevention of a bacterial infection, especially an infection with Streptococcus pneumoniae (S. pneumoniae).

Abstract: The removal of the glycosidic phosphate from the reducing end of the derived LPS molecule creates an aldehydo functionality which causes the formation of an immunologically dominant neo-epitope. Conjugation to the reducing end of a carbohydrate molecule following removal of the glycosidic phosphate traps the reducing glucosamine residue in an open-chain form which surprisingly was found to dominate the immune response. We therefore modified our conjugation strategy to avoid this open-chain form, by utilising the amino functionality created by the isolated amidase activity from Dictyostelium discoideum, concomitant with a unique blocking and un-blocking strategy to protect the immunologically important phosphoethanolamine inner core residue. These antigenic structures are useful in producing vaccines and compounds helpful in combating Gram-negative bacteria.

Abstract: The present invention relates to methods and compositions for treating urinary tract infections. In particular, the present invention relates to vaccines and immune modulators for treating urinary tract infections.

Abstract: Multicomponent vaccines are provided which aid in the prevention and treatment of staphylococcal infections and which include certain selected combinations of bacterial binding proteins or fragments thereof, or antibodies to those proteins or fragments. By careful selection of the proteins, fragments, or antibodies, a vaccine is provided that imparts protection against a broad spectrum of Staphylococcus and other bacterial strains and against proteins that are expressed at different stages of the logarithmic growth curve. In one embodiment of the invention, a composition is provided that includes a fibrinogen binding domain of a fibrinogen binding protein and a bacterial component such as a capsular polysaccharide, and both active and passive vaccines based on these components are also provided, along with methods of treating infection using these compositions and vaccines.

Abstract: Immunogenic compositions and methods for eliciting an immune response against S. epidermidis and other related staphylococci are provided. The immunogenic compositions can include immunogenic conjugates of poly-?-glutamic acid (such as ?DLPGA) polypeptides of S. epidermidis, or related staphylococci that express a ?PGA polypeptide. The ?PGA conjugates elicit an effective immune response against S. epidermidis, or other staphylococci, in subjects to which the conjugates are administered. A method of treating an infection caused by a Staphylococcus organism that expresses cap genes is also disclosed. The method can include selecting a subject who is at risk of or has been diagnosed with the infection by the Staphylococcus organism which expresses ?PGA from the cap genes. Further, the expression of a ?PGA polypeptide by the organism can then be altered.

Abstract: Disclosed are immunogenic conjugates and therapeutic compositions that include such immunogenic conjugates. Also disclosed are methods of treating and/or inhibiting an Shigella sonnei infection. The disclosed immunogenic conjugates have the general structure: Pr—Sr—O—N?C-Kdo-OS wherein Pr is a carrier protein, Sr is an optional spacer moiety, Kdo is an 3-deoxy-D-manno-octulosonic acid or a derivative thereof, and OS is an oligosaccharide or polysaccharide obtained from S. sonnei. In specific examples, the immunogenic conjugates include the core oligosaccharide obtained from S. sonnei having the structure: wherein R is between 1 and 10 disaccharide repeat units. In specific examples, the disaccharide repeat unit included in the immunogenic conjugate has the structure: ?-L-AltNAcA-3-?-FucNAc4N-4-.

Abstract: Combination vaccines for treating or preventing Neisseria meningitidis infection are described. The vaccines include Neisseria meningitidis serogroup B proteoliposomic vesicles and Neissera meningitidis serogroup C conjugated oligosaccharides.

Abstract: The present invention relates to methods and compositions for treatment of microbial infections and for the enhancement of resistance to infection. The invention comprises administration of an effective amount of bacterial lysate compositions for the treatment of pathological conditions of microbial infections. The present invention can also be used to enhance the immune system to prevent infections by the administration of an effective amount of the compositions.

Abstract: Various improvements to vaccines that include a serogroup C meningococcal conjugate antigen, including: (a) co-administration with acellular B. pertussis antigen; (b) co-administration with an inactivated poliovirus antigen; (c) supply in a kit together with a separate pneumococcal conjugate component, which may be in a liquid form; and (d) use in combination with a pneumococcal conjugate antigen but without an aluminum phosphate adjuvant. A kit may have: (a) a first immunogenic component that comprises an aqueous formulation of a conjugated capsular saccharide from Streptococcus pneumoniae; (b) a second immunogenic component that comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C.

Abstract: The present invention provides a method for the purification of complexes comprising a stress protein complexed to a peptide or peptide fragment, from a source mixture, typically a cell lysate. The improved method of the invention provides for protein complexes to be purified using ion exchange based methods, without the need to use chemicals such as chaotropes and ampholytes. The purified complexes can be used as the immunogenic determinant in vaccine compositions for the treatment or prevention of infectious diseases or cancerous conditions.

Abstract: The present invention relates to a combination vaccine comprising a mixture of antigens for protection against diseases such as diphtheria, tetanus, acellular pertussis, and infections caused by Haemophilus influenzae and polio viruses. The present invention also relates to inclusion of antigens for protection against infections caused Hepatitis virus and other pathogens, such that administration of the vaccine can simultaneously immunize a subject against more than one pathogen. The invention in particular relates to a fully liquid stable combination vaccine comprising the antigens as indicated above and the methods for manufacturing the same.

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.

Abstract: Antitoxin and vaccine compositions based on nodavirus VLPs are provided. Anthrax antitoxin and vaccine compositions are provided. Methods of treating toxins with VLP-based antitoxins are provided. Methods of raising an immune response with immunogen decorated VLPs are provided.

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: The present invention provides an immunogenic composition comprising an antigen or antigen composition and an adjuvant composition comprising an oil in water emulsion.

Abstract: While oil-in-water emulsions are excellent adjuvants for influenza vaccines, their efficacy can be improved by additionally including other immunostimulating agent(s) to improve cytokine responses, such as ?-interferon response. Thus, a vaccine comprises (i) an influenza virus antigen; (ii) an oil-in-water emulsion adjuvant; and (iii) a cytokine-inducing agent.

Abstract: The invention provides Ehrlichia canis antigens that can be used to detect E. canis infected animals regardless of whether the animals have been vaccinated for E. canis. The invention also provides compositions and methods for determining the presence of E. canis antigens and antibodies.

Abstract: The present invention relates to immunogenic compositions comprising a recombinant Neisseria gonorrhoeae OpcA and methods of eliciting an immune response in a mammal by administering a formulation comprising N. gonorrhoeae OpcA or a portion or fragment of N. gonorrhoeae OpcA. The invention also provides for methods and kits for diagnosing N. gonorrhoeae infection using said recombinant N. gonorrhoeae OpcA.

Abstract: The invention relates to a vaccine for the treatment of disease caused by Neisseria, the vaccine comprising o more immunogenic components for Neisseria serogroups, as well as antibodies to the immunogenic components and m preventing and treating Neisseria infections.

Abstract: A composition for mucosal delivery, comprising two or more of the following: (a) an antigen which induces an immune response against Haemophilus influenzae; (b) an antigen which induces an immune response against Neisseria meningitidis; and (c) an antigen which induces an immune response against Streptococcus pneumoniae. The combination allows a single dose for immunising against three separate causes of a common disease, namely bacterial meningitis.

Abstract: The degree of polymerisation (DP) is an important parameter for analysis of saccharide antigens, particularly in glycoconjugates. The invention provides methods that can be used to measure DP for capsular saccharides, particularly for meningococcal saccharides e.g. from serogroups W135 and Y. A preferred method is based on reduction of terminal sialic acid residues on saccharides, with DP then being calculated by comparing the molar ratio of total sialic acid to reduced sialic acid.

Abstract: The invention provides immunogenic compositions for mucosal delivery comprising capsular saccharides from at least two of serogroups A, C, W135 and Y of N. meningitidis. It is preferred that the capsular saccharides in the compositions of the invention are conjugated to carrier protein(s) and/or are oligosaccharides. Conjugated oligosaccharide antigens are particularly preferred. The invention also provides immunogenic compositions comprising (a) a capsular saccharide antigen from serogroup C of N. meningitidis, and (b) a chitosan adjuvant. The composition preferably comprises (c) one or more further antigens and/or (d) one or more further adjuvants. The compositions are particularly suitable for mucosal delivery, including intranasal delivery. The use of chitosan and/or detoxified ADP-ribosylating toxin adjuvants enhances anti-meningococcal mucosal immune responses and can shift the Th1/Th2 bias of the responses.

Abstract: Two Vi conjugates have been prepared by carbodiimide-mediated synthesis, using adipic acid dihydrazide derivatized CRM197 (a non-toxic variant of diphtheria toxin) and tetanus toxoid, as carrier proteins.

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. Methods for making an immunogenic conjugate comprising Streptococcus pneumoniae serotype 19A polysaccharide are also provided in which the serotype 19A polysaccharide is co-lyophilized with a carrier protein and conjugation is carried out in dimethyl sulfoxide (DMSO) via a reductive amination mechanism.

Abstract: Provided herein are self-assembling pharmaceutical compositions comprising a heat shock protein fused to a biotin-binding protein, wherein the biotin-binding protein is non-covalently bound to four biotinylated components, and further wherein at least two of the four biotinylated components are not identical.

Abstract: The invention concerns a pharmaceutical composition for treating or preventing a certain number of infections caused by pathogenic agents such as bacteria, comprising as immunogen, one or several polyosides derived from one or several pathogenic agents. The polyosides are in the form of conjugates, coupled with a carrier protein. The composition contains at least two types of conjugates, each being at least characterised by a different protein carrier.

Abstract: Recombinant fragments of Factor C are disclosed. These proteins and peptides show great potency in recognizing, binding to, neutralizing and removing endotoxin. These molecules can thus be used for anti-microbial, anti-endotoxin, and anti-sepsis therapy. SSCrFCES is a 38 kDa protein representing the LPS-binding domain of Factor C. The ability of SSCrFCES to bind lipid A was analyzed using an ELISA-based assay as well as surface plasmon resonance. Surface plasmon resonance similarly carried out for SSCrFC-sushi-1,2,3-GFP, SSCrFC-sushi-1GFP, and SSCrFC-sushi-3GFP confirmed their superior affinity for endotoxin. The 50% endotoxin-neutralizing concentration of SSCrFCES against 200 EU of endotoxin is 0.069 ?M, suggesting that SSCrFCES is an effective inhibitor of LAL coagulation cascade. Although partially attenuated by human serum, as low as 1 ?M of SSCrFCES inhibits the LPS-induced secretion of hTNF-? and hIL-8 by THP-1 and human pheripheral blood mononuclear cells with a potency more superior than polymyxin B.

Abstract: The present invention is directed to a bioconjugate vaccine, such as an 01-bioconjugate vaccine, comprising: a protein carrier comprising a protein carrier containing at least one consensus sequence, D/E-X—N—Z—S/T, wherein X and Z may be any natural amino acid except proline; at least one antigenic polysaccharide from at least one pathogenic bacterium, linked to the protein carrier; and, optionally, an adjuvant. In another aspect, the present invention is directed to a method of producing an O1-bioconjugate in a bioreactor comprising a number steps.