Abstract: Compositions and methods for the detection, prevention, or treatment of anthrax or other infectious diseases. In one aspect, the present invention provides methods for immunizing humans or animals against Bacillus anthracis or other capsulated pathogens. The methods include administering a capsular polypeptide of a pathogen of interest and a CD40 agonist to a human or animal. The capsular polypeptide or the CD40 agonist is administered in such an amount or frequency that an immunoprotective response can be elicited in the human or animal against the pathogen of interest. In another aspect, the present invention provides methods of using passive immunization with anti-capsular polypeptide antibodies to prevent or treat infections caused by Bacillus anthracis or other pathogens. In yet another aspect, the present invention provides methods useful for diagnosis of anthrax by detection of capsular polypeptide in serum or other biological samples.

Abstract: Monoclonal antibodies, and antigen binding fragments thereof, which bind to Protein A of Staphylococcus aureus are provided.

Abstract: The invention fully humanized monoclonal antibodies that neutralize Bacillus anthracis. Also provided are methods of treating or preventing a Bacillus anthracis infection. The invention also provides methods of passive vaccination of a subject against Bacillus anthracis.

Abstract: The characterization and isolation of F20G75, F20G76 and F20G77, anti-PA monoclonal antibodies which also have neutralizing activities is described. The monoclonal antibodies may be used as a pharmaceutical composition for treating individuals suspected of or at risk of or having a Bacillus anthracis infection. The monoclonal antibodies bind to a specific region comprising amino acids 311-316 of PA, ASFFDI or a larger fragment comprising amino acids 301-330 of PA, SEVHGNAEVHASFFDIGSSVSAGFSNSNSS. Vaccines comprising these peptides may be used to immunize individuals against Bacillus anthracis infection.

Abstract: This invention provides antibodies that specifically bind to and neutralize botulinum neurotoxin type A (BoNT/A) and the epitopes bound by those antibodies. The antibodies and derivatives thereof and/or other antibodies that specifically bind to the neutralizing epitopes provided herein can be used to neutralize botulinum neurotoxin and are therefore also useful in the treatment of botulism.

Abstract: A pharmaceutical composition comprising (i) a first specific binding agent selected from an antibody or a large binding fragment of an antibody which specifically binds a target toxin, and (ii) a second specific binding agent which comprises a small binding fragment of an antibody which binds said toxin. The compositions are used in the treatment of toxin poisoning, for example following exposure to toxins such as Botulinum toxins.

Abstract: A bioinformatic method is provided for identifying and isolating proteins with MSCRAMM®—like characteristics from Gram positive bacteria, such as Enterococcus, Staphylococcus, Streptococcus and Bacillus bacteria, which can then be utilized in methods to prevent and treat infections caused by Gram-positive bacteria. The method involves identifying from sequence information those proteins with a putative C-terminal LPXTG (SEQ ID NO:1) cell wall sorting signal and other structural similarities to MSCRAMM® proteins having the LPXTG-anchored cell wall proteins. The MSCRAMM® proteins and immunogenic regions therein that are identified and isolated using the present invention may be used to generate antibodies useful in the diagnosis, treatment or prevention of Gram positive bacterial infections.

Abstract: A pharmaceutical composition includes a purified antibody and a pharmaceutically acceptable carrier. The antibody is enriched for immunoglobulins having both an antigen-binding portion that binds a Staphylococcus aureus capsular polysaccharide antigen and a constant region that does not bind staphylococcal protein A.

Abstract: The present invention provides a method for the treatment and/or prevention of bacterial infection in central nervous system and/or peripheral blood circulation in a mammal by administering effective amount of outer membrane protein A (OmpA) or its derivatives to a mammal. Also provided is an antibody binding to OmpA that can assay OmpA levels in a biological sample and detect or diagnose bacterial infection in central nervous system and/or peripheral blood circulation.

Abstract: The present invention is concerned with compounds, medicaments and treatments for Clostridium difficile infection, together with novel isolated antibodies and their use in same. The present invention is also concerned with the treatment and prophylaxis of E. faecium and E. faecalis infection and provides medicaments and treatments for same.

Abstract: Purified antibodies that bind to M. tuberculosis ERP protein are disclosed. In one embodiment, a purified antibody, which binds specifically with a polypeptide comprising SEQ ID NO: 39 or SEQ ID NO: 41 is provided. In some embodiments the polypeptide has a theoretical molecular weight of about 28 kDa. In other embodiments the polypeptide has an observed molecular weight of about 36 kDa, as determined by denaturing polyacrylamide gel electrophoresis (SDS-PAGE). The purified antibody may be a monoclonal or a polyclonal antibody. Further embodiments provide antibodies that does not bind specifically with M. leprae P28 protein. The antibodies of the invention have many uses including the identification of M. tuberculosis.

Abstract: Disclosed herein are novel methods for screening for compounds useful in treating or preventing tuberculosis. In exemplary embodiments, screening methods are based on the implementation or manipulation of triacylglycerol hydrolase like polypeptides or polynucleotides encoding the same. The methods are useful in identifying agents active against TB infection.

Abstract: The present application relates to a human monoclonal antibody specific for the serotype IATS 06 of P. aeruginosa, a hybridoma producing it, nucleic acids encoding it, and host cells transfected therewith. Further, the present invention relates to methods for producing said monoclonal antibody. In addition, the present invention relates to pharmaceutical compositions comprising at least one antibody or at least one nucleic acid encoding said antibody.

Abstract: A composition for treating a subject is provided. The composition includes dimeric or polymeric secretory IgA therapeutic. Formulating agents are mixed with the dimeric or polymeric secretory IgA to yield a dosing form of a capsule, tablet, and a suppository. A process for manufacturing a medicament for the treatment of C. difficile associated disease in a human is also provided wherein dimeric or polymeric IgA is modified with secretory component to form a dimeric or polymeric secretory IgA therapeutic. The dimeric or polymeric secretory IgA therapeutic is then mixed with formulating agents to create a capsule, tablet, or suppository dosing form. The therapeutic is amenable to enrobement directly through microencapsulation or the dosing form is coated with an enteric coating. A method of C. difficile treatment with the therapeutic is also provided that is amenable to supplementation with concurrent or prior antibiotic administration.

Abstract: The invention concerns Mycobacterium strains whereof the erp gene is modified and a vaccine composition containing same. The modification of the erp gene decreases the virulence and the persistence of the Mycobacterium strains.

Abstract: The invention provides isolated polypeptide and nucleic acid sequences derived from Staphylococcus epidermidis that are useful in diagnosis and therapy of pathological conditions; antibodies against the polypeptides; and methods for the production of the polypeptides. The invention also provides methods for the detection, prevention and treatment of pathological conditions resulting from bacterial infection.

Abstract: A protein from Streptococcus pyogenes, serotype Ml has been characterized. This protein, called protein SIC, plays a role in S. pyogenes pathogenicity and virulence. It inhibits hemolysis by interacting with the plasma proteins clusterin, and members of the cystatin protein super family such as histidine rich glycoprotein (HRG). The protein, comprises at least one of the following partial amino acid sequences: (a) glu thr tyr thr ser arg asn phe; (b) asp trp ser gly asp asp trp pro glu asp asp trp; Cc) arg ser gly val gly leu ser gln tyr gly trp ser; (d) trp ser ser asp lys lys asp glu thr glu asp lys thr; (e) gly thr gly tyr glu lys arg asp asp trp gly gly pro gly; (f) lys arg asp asp trp arg gly pro gly his ile pro lys pro. The protein and antibodies specific for the protein can be used in analytical procedures for determining the presence of virulent Streptococcus pyo genes in a sample. The protein can also be used in vaccine compositions.

Abstract: The present invention describes a detoxified Gram negative J5 core lipopolysaccharide/group B meningococcal outer membrane protein complex vaccine given in conjunction with CpG 7909 adjuvant. This vaccine composition can be used for either active or passive immunization of mammals for the prevention or treatment of sepsis and infection with Gram negative bacteria. The addition of CpG to the vaccine was shown to markedly increase the antibody response in mice. Furthermore, the ability of the endotoxin vaccine in protecting against Gram-negative bacteria such as Francisella tularensis in vivo is also demonstrated herein.

Abstract: Anti-?-1,3-glucan antibodies have been found to be protective against systemic fungal infection with Candida albicans. The present invention provides monoclonal antibodies that bind to ?-1,3-glucan, hybridoma cell lines producing the antibodies, compositions comprising the antibodies and methods of using such antibodies for treatment of microbial infections, particularly against Candida albicans and Aspergillus fumigatis infections. The antibodies of the present invention are not specific for ?-1,6-glucan.

Abstract: Disclosed herein are novel methods for screening for compounds useful in treating or preventing tuberculosis. In exemplary embodiments, screening methods are based on the implementation or manipulation of triacylglycerol synthase like polypeptides or polynucleotides encoding the same. The methods are useful in identifying agents active against TB infection.

Abstract: The use of (i) an antibody specific for Yersinia pestis F1-antigen, or a binding fragment thereof, or (ii) an antibody specific for Yersinia pestis V-antigen, or a binding fragment thereof, or a combination of (i) and (ii), in the production of a medicament for the treatment of infection by Yersinia pestis. It has been found that such treatments are effective therapies for Yersinia pestis infection. In addition, the combination produces a synergistic effect when used prophylactically.

Abstract: The present invention provides a novel class of monoclonal antibodies which have a high affinity, broad spectrum neutralizing reactivity to flagellin from various Gram-negative bacteria including, but not limited to, E. coli, Salmonella, Serratia, Proteus, Enterobacter, Citrobacter, Campylobacter and Pseudomonas. The present invention further provides methods of treating inflammatory bowel disease (IBD) and methods of treating enterobacterial infections using anti-flagellin antibodies in humans, other animals and birds.

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 provides an assay for detection of M. bovis-infected animals. A tracer, comprising a peptide of M. bovis protein MPB70 conjugated to a fluorophore, is added to a serum sample from an animal to form a mixture. The fluorescence polarization of the mixture in then measured and compared to the fluorescence polarization of a control. The present invention further provides a tracer for use in fluorescence polarization assay to detect antibodies specific for M. bovis. The tracer comprises a peptide of M. bovis protein MPB70 conjugated to a fluorophore, such that the tracer is able to bind to antibodies specific for M. bovis to produce a detectable change in fluorescence polarization.

Abstract: A method for improving body weight gain and increasing feed conversion efficiency of in animals by feeding the animals a diet containing antibodies against anti-nutritional factors in food.

Abstract: The invention relates to Leptospiral surface proteins, and the nucleic acid molecules which encode them. Various uses are described, including immunoprophylactic, diagnostic and therapeutic methods.

Abstract: A negatively-charged Staphylococcus antigen contains amino acids and a N-acetylated hexosamine as a major carbohydrate component. The antigen is common to many coagulase-negative strains of Staphylococcus, including S. epidermidis, S. haemolyticus, and S. hominis. Staphylococcus strains that carry the antigen include many clinically significant strains of Staphylococcus. The antigen and antibodies to the antigen are useful in kits and assays for diagnosing Staphylococcus infection. Vaccines of the antigen and of whole cells that carry the antigen also are disclosed.

Abstract: Antibodies that bind to the M. tuberculosis Des protein are provided.

Abstract: Vaccines comprising an S. aureus alpha-toxin antigen and a pharmaceutically acceptable carrier are provided, and are useful for treating and preventing infections. The S. aureus alpha-toxin antigen may contain at least two alterations that reduce its toxicity and/or may be conjugated to or co-administered with another bacterial antigen. The vaccines may comprise one or more other bacterial antigens. Antibody compositions comprising antibodies to alpha-toxin and optionally one or more other bacterial antigens also are provided, and are useful for treating and preventing infections.

Abstract: A method of inhibiting, moderating or diagnosing Pseudomonas aeruginosa infection is disclosed. In one embodiment, this method comprises inoculating a patient with an effective amount of PcrV antigen.

Abstract: B-cell epitope peptides of HSP 65, particularly the peptides comprising the amino acid sequence substantially as denoted by SEQ ID: Nos. 1-5 and their biologically functional homologues and derivatives thereof. Also included are polyclonal and monoclonal antibodies directed against them and their compositions for passive immunization against inflammatory and autoimmune diseases and in the treatment of inflammatory and autoimmune diseases. Also encompassed are diagnostic uses of these antibodies, for identifying people at risk of developing arthritis or diabetes, and a method of monitoring progress of the disease conditions and disease prognosis.

Abstract: The present invention provides compositions, including pharmaceutical compositions, comprising an amount of an antibody, antibody fragment or antibody conjugate sufficient to treat Group A streptococcus (GAS) infection or complication thereof in a subject or a disease or complication associated with GAS infection in a subject wherein said antibody, antibody fragment or antibody conjugate binds immunospecifically to a B-cell epitope of GAS M-protein. The present invention also provides methods for the prophylactic or therapeutic treatment of infection by GAS and complications thereof comprising administering the compositions to a subject in need thereof.

Abstract: The present invention provides methods and compositions for said inhibition of drug resistance. In one embodiment, said invention provides methods and compositions for said inhibition of antibiotic resistance. The invention generally involves said administration of achaogens, agents that inhibit said mutational process, to inhibit said evolution of drug resistance. Also, described herein are compositions that are suitable for use as achaogens.

Abstract: Isolated human monoclonal antibodies which bind to Anthrax protective antigen are disclosed. The human antibodies can be produced in a non-human transgenic animal, e.g., a transgenic mouse, capable of producing multiple isotypes of human monoclonal antibodies by undergoing V-D-J recombination and isotype switching. Also disclosed are derivatives of the human antibodies (e.g., bispecific antibodies and immunoconjugates), pharmaceutical compositions comprising the human antibodies, non-human transgenic animals and hybridomas which produce the human antibodies, and therapeutic and diagnostic methods for using the human antibodies.

Abstract: A highly efficient method for generating human antibodies using recall technology is provided. In one aspect, human antibodies which are specific to the anthrax toxin are provided. In one aspect, human peripheral blood cells that have been pre-exposed to anthrax toxin are used in the SCID mouse model. This method results in high human antibody titers which are primarily of the IgG isotype and which contain antibodies of high specificity and affinity to desired antigens. The antibodies generated by this method can be used therapeutically and prophylactically for preventing or treating mammals exposed to anthrax. Thus, in one embodiment, a prophylactic or therapeutic agent used to counter the effects of anthrax toxin, released as a mechanism of bioterrorism, is provided. In one embodiment, a formulation and method for preventing and/or treating anthrax infection comprising a binding agent that prevents the assembly of the PA63 heptamer is also provided.

Abstract: A highly efficient method for generating human antibodies using recall technology is provided. In one aspect, human antibodies which are specific to the anthrax toxin are provided. In one aspect, human peripheral blood cells that have been pre-exposed to anthrax toxin are used in the SCID mouse model. This method results in high human antibody titers which are primarily of the IgG isotype and which contain antibodies of high specificity and affinity to desired antigens. The antibodies generated by this method can be used therapeutically and prophylactically for preventing or treating mammals exposed to anthrax. Thus, in one embodiment, a prophylactic or therapeutic agent used to counter the effects of anthrax toxin, released as a mechanism of bioterrorism, is provided. In one embodiment, a formulation and method for preventing and/or treating anthrax infection comprising a binding agent that prevents the assembly of the PA63 heptamer is also provided.

Abstract: The present invention relates to a bi-specific antibody or antibody fragment having at least one arm that is reactive against a targeted tissue and at least one other arm that is reactive against a linker moiety. The linker moiety encompasses a hapten to which antibodies have been prepared. The antigenic linker is conjugated to one or more therapeutic or diagnostic agents or enzymes. The invention provides constructs and methods for producing the bispecific antibodies or antibody fragments, as well as methods for using them.

Abstract: A novel Helicobacter pylori blood group antigen binding (BAB) adhesin protein was isolated and purified, whereby said protein or fractions thereof bind specifically to fucosylated blood group antigens. The protein sequence of said adhesin is disclosed in this application. Simultaneously the DNA sequences for two genes, babA and babB, producing highly similar proteins, are disclosed. Said adhesin and/or DNA is useful for diagnose and therapy and/or prophylaxis directed against H. pylori induced infections, e.g. gastritis and acid peptic disease, i.e. active vaccination. A new immunoglobulin composition, which exhibits specific activity to a Lewisb antigen binding Helicobacter pylori adhesin, or preferably, monoclonal and/or polyclonal antibodies to said adhesin offer a new and more efficient method of treatment and/or prevention of gastrointestinal diseases, caused by Helicobacter pylori or other Helicobacter species, i.e. passive vaccination.

Abstract: ELISA, Western Blot, and a peptide-based ELISA were applied to clinical specimens from patients with clinical symptoms of tick borne diseases, including Lyme disease. Peptides from different components of Borrelia during different cycles, including peptides from outer surface protein, leukocyte function associated antigens, immunodominant antigens, variable major proteins, and peptides from decorin-binding proteins of Borrelial subspecies (B. sensu stricto. B. afzelii, B. garinii) were used. Antibodies against specific peptides from Babesia and Ehrlichia were also measured.

Abstract: The present invention relates to a monoclonal antibody binding specifically to the p60 protein of Listeria monocytogenes, a hybridoma cell producing the monoclonal antibody, a test kit comprising the monoclonal antibody, and a method for detecting Listeria monocytogenes using the monoclonal antibody. The inventive monoclonal selectively recognizes only Listeria monocytogenes, so that the use of such an antibody allows for rapid determination of the food contamination with these bacteria pathogenic to humans.

Abstract: The bacterial protein OpuCA, an intracellular part of an ABC transporter, has been shown to interact directly with TRAP. The present invention provides methods and compositions directed at interfering with the interaction between OpuCA and TRAP. The resulting inhibition of TRAP advantageously will reduce pathogenesis of all bacteria that utilize this pathway. The present invention further provides methods and compositions directed at interfering with the interaction between TRAP and the extracellular substrate binding protein OpuCC, or the membrane-associated proteins OpuCB and OpuCD, which, like OpuCA, are encoded by the bacterial OpuC operon. Accordingly, the present methods and compositions will be useful in treating diseases caused by such bacteria.

Abstract: A conjugate molecule comprising an oligo- or polysaccharide covalently bound to a carrier and its use as potential vaccine against infection by S. Flexneri.

Abstract: The isolation of genes and proteins from Staphylococcus aureus is provided, and the nucleic acids coding for specific regions of the S. aureus CIfA protein are described. The nucleic acids encode proteins that can be useful as vaccines or in pharmaceutical compositions for application to prevent infection, promotion of wound healing, blocking adherence to indwelling medical devices, or diagnosis of infection.

Abstract: Monoclonal antibodies which can bind to the ClfA protein and which are generated from binding subdomains or active fragments of the ClfA protein from Staphylococcus aureus, including the active fragments proteins from its fibrinogen binding domain such as Clf40 protein, the Clf33 protein, or ClfA N3, are provided which can be useful in the treatment and protection against infection from staphylococcal bacteria such as Staphylococcus aureus. In addition, medical instruments can be treated using the monoclonal antibodies of the invention in order to reduce or eliminate the possibility of their becoming infected or further spreading the infection. In particular, the antibodies of the present invention are advantageous because they can prevent adherence of the bacteria to host cells by impairing or inhibiting the ability of S. aureus ClfA to bind to fibrinogen or fibrin, and thus can be utilized in methods or treating or preventing staphylococcal inventions.

Abstract: The invention relates to Leptospiral surface proteins, and the nucleic acid molecules which encode them. Various uses are described, including immunoprophylactic, diagnostic and therapeutic methods.

Abstract: Novel proteins and their corresponding nucleotide sequences in enteroaggregative Escherichia coli (EAEC) are provided. In particular, Aap and the five gene cluster (aat) of the AA probe region of the pAA plasmid of EAEC 042 have been identified, sequenced, and further characterized. The use of these novel proteins and their corresponding nucleotide sequences for diagnosis, therapy, and prevention of EAEC infections is also provided.

Abstract: Novel proteins and their corresponding nucleotide sequences in enteroaggregative Escherichia coli (EAEC) are provided. In particular, Aap and the five gene cluster (aat) of the AA probe region of the pAA plasmid of EAEC 042 have been identified, sequenced, and further characterized. The use of these novel proteins and their corresponding nucleotide sequences for diagnosis, therapy, and prevention of EAEC infections is also provided.

Abstract: The present invention encompasses monoclonal antibodies that bind to lipoteichoic acid (LTA) of Gram positive bacteria. The antibodies also bind to whole bacteria and enhance phagocytosis and killing of the bacteria in vitro. The invention also provides antibodies having human sequences (chimeric, humanized and human antibodies). The invention also sets forth the variable regions of three antibodies within the invention and presents the striking homology between them.

Abstract: Antibodies to the CNA protein and to other regions from the collagen binding domain, including domain CNA19, are provided, and antibodies produced in this manner have been shown to be cross reactive to both Staphylococcus aureus and Staphylococcus epidermidis bacteria and which can thus be used in the prevention and treatment of infections caused by both of these types of bacteria. In addition, medical instruments can be treated using the antibodies of the invention in order to reduce or eliminate the possibility of their becoming infected or further spreading the infection. In particular, the proteins are advantageous because they are cross-reactive and may thus be administered to patients so as to reduce or prevent severe infection by staphylococcal bacteria of more than one species.

Abstract: The present invention relates to peptides, particularly human monoclonal antibodies, that bind specifically to P. aeruginosa mucoid exopolysaccharide. The invention further provides methods for using these peptides in the diagnosis, prophylaxis and therapy of P. aeruginosa infection and related disorders (e.g., cystic fibrosis). Some antibodies of the invention enhance opsonophagocytic killing of multiple mucoid strains of P. aeruginosa. Compositions of these peptides, including pharmaceutical compositions, are also provided, as are functionally equivalent variants of such peptides.