Abstract: This invention relates to a method for treating or preventing (including immunising against) post-wearing multisystemic wasting syndrome (PMWS) and/or porcine dermatitis and nephropathy syndrome (PDNS) in a subject comprising administering an effective amount of a pharmaceutical composition or immune modulator composition comprising a whole cell of a bacterium from one or more of the genera Rhodococcus, Gordonia, Nocardia, Dietzia, Tsukamurella and Nocardioides, to said subject. In addition the method relates to the use of an immune modulator composition or a pharmaceutical composition comprising a whole cell of a bacterium from the genera Rhodococcus, Gordonia, Nocardia, Dietzia, Tsukamurella and Nocardioides, in the manufacture of a medicament for the treatment or prevention of post-wearing multisystemic wasting syndrome (PMWS) and/or porcine dermatitis and nephropathy syndrome (PDNS).

Abstract: An antigen composition for stimulating an immune response in an inoculated avian species to at least one intestinal pathogenic organism includes seven field strains of E. coli, Pseudomona aeruginosa, Aerobacter aerogenes, Salmonella enteritidis, Salmonella typhimurium, Salmonella agona, and Salmonella Kentucky. The antigen, composition can be used alone or in combination with a Marek's Disease vaccine to reduce shedding of E. coli and/or Salmonella bacteria.

Abstract: This invention provides a method for identifying strains of nontypeable Haemophilus influenzae that can be used as immunogenic compositions having specificity against a plurality of Haemophilus influenzae strains. The invention also provides compositions comprising whole cell bacteria or outer membrane protein P2 obtained from the strains for use as vaccines.

Abstract: The present invention is directed to an immunogenic composition for inducing an immune response against lysine decarboxylase for treating or preventing periodontitis in a subject. The present invention is also directed to methods for inducing an immunogenic response in a subject by administering such immunogenic composition.

Abstract: The invention of novel, effective vaccines against Mycoplasma bovis for use in cattle is described. These vaccines demonstrate no undesirable side effects and protect against M. bovis related disease, such as contagious mastitis, respiratory pneumonia, joint infections, keratoconjunctivitis and middle ear infections. The novel vaccines also lessen the effect of M. bovis infections on milk production, weight gain and animal health. Methods of diagnosing, characterizing and treating M. bovis infections as specific biotypes are also disclosed. Vaccine compositions made in accordance with the invention may be either of the attenuated or inactivated variety. Vaccines may also include antigens from other pathogens so as to provide a protective immunogenic response to diseases other than those caused by M. bovis.

Abstract: The invention provides a vaccine for immunizing poultry and other animals against infection by a gram-negative bacteria, and a method of immunizing an animal using the vaccine. The vaccine may contain purified siderophore receptor proteins derived from a single strain or species of gram-negative bacteria or other organism, which are cross-reactive with siderophores produced by two or more strains, species or genera of gram-negative bacteria. The invention further provides a process for isolating and purifying the siderophore receptor proteins, and for preparing a vaccine containing the proteins. Also provided is a method for diagnosing gram-negative sepsis.

Abstract: A composition is prepared from a mixture of different vesicles, such as outer membrane vesicles (OMVs) and vaccines are based thereon. Another composition comprises in a single vesicle a combination of antigens and/or other vesicle components deriving from separate vesicles; again vaccines are prepared therefrom.

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: The present invention provides a mycoplasma vaccine, its preparation and application thereof. The foregoing mycoplasma vaccine comprises inactivated Mycoplasma hyorhinis ATIT-7 only or the mixture of inactivated Mycoplasma hyorhinis ATIT-7 and inactivated Mycoplasma hyopneumoniae, which effectively prevents the infection of swine enzootic pneumonia in pigs.

Abstract: Methods and compositions for increasing antibody titer in egg yolks and for using the antibodies are disclosed.

Abstract: Mutant cholera holotoxins having single or double amino acid substitutions or insertions have reduced toxicity compared to the wild-type cholera holotoxin. The mutant cholera holotoxins are useful as adjuvants in antigenic compositions to enhance the immune response in a vertebrate host to a selected antigen from a pathogenic bacterium, virus, fungus, or parasite, a cancer cell, a tumor cell, an allergen, or a self-molecule.

Abstract: Immunogenic compositions and subunit vaccines for dental caries are described which comprise peptide subunits of glucan binding protein-B and peptide subunits of glucan binding protein-B in combination with peptide subunits of glucosyltransferase. Methods of provoking an immune response to S. mutans glucan binding protein-B or glucosyltransferase. Methods of immunizing a mammal against dental caries are also described, along with antibodies which bind particular epitopes of glucan binding protein-B or glucosyltransferase.

Abstract: Inactivated scours vaccines for immunization and protection of bovine animals from disease caused by infection with bovine rotavirus and bovine coronavirus, which comprise and effective amount of at least one inactivated viral strain are described. Polyvalent inactivated vaccines further comprising an effective amount of an antigenic component which is protective against one or more additional pathogenic organisms or viruses are also disclosed. Said vaccines are prepared from one or more strains of rota- and coronavirus, C. perfringens Type C bacteria and E. coli bacteria, and combinations thereof. Preferably, a polyvalent inactivated vaccine is provided for parenteral administration. Passive immunity is achieved in neonatal calves via immunization of pregnant cows prior to birth.

Abstract: Compositions and methods for stimulating an immune response against a secreted enterohemorragic Escherichia coli (EHEC) antigen are disclosed. The compositions comprise EHEC cell culture supernatants.

Abstract: There is provided a vaccine composition comprising a combination of a genetic deletion mutant S. typhimurium microorganism and a genetic deletion mutant E. coli microorganism, suitable for mass application to poultry. Also provided is a safe and effective method to protect poultry against the ravages of E. coli and Salmonella infection and disease.

Abstract: Mucosal DTPa vaccines, especially intranasal vaccines, comprising (a) a diphtheria antigen, a tetanus antigen and an acellular pertussis antigen, and (b) a detoxified mutant of cholera toxin (CT) or E. coli heat labile toxin (LT). Component (b) acts as a mucosal adjuvant. The acellular pertussis antigen preferably comprises pertussis holotoxin (PT) and filamentous haemagglutinin (FHA) and, optionally, pertactin. The mucosally-delivered combined DTPa formulation is capable of generating a level of protection against B. pertussis infection equivalent to that observed by alum-adjuvanted parenteral administration.

Abstract: Compositions and methods for making and using therapeutic formulations of multivalent hybrid polypeptides comprising immunogenic peptides of M proteins from various different serotypes of group A streptococci and antibodies thereto are provided. Also provided are nucleic acids encoding such hybrid polypeptides. The hybrid polypeptide formulations may be used, for example, in methods for treating or preventing a microbial infection and eliciting a protective immune response having broadly protective opsonic antibodies in the absence of tissue cross-reactive antibodies.

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 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 coccidia strains and, in one embodiment, to microbiological cultures comprising such strains. In preferred embodiments, the coccidia strains are selected for tolerance to one group of coccidiostatic drugs, sensitivity to a second group of coccidiostatic drugs, and decreased proliferative capacity. Another embodiment of the invention relates to vaccines based on the coccidia strains according to the invention.

Abstract: The present invention is concerned with a fragment of IgA1-protease having 40 to 200 amino acid residues and comprising at least 40 amino acids of an amino acid sequence as shown in SEQ ID NO:1, beginning with the amino acid in any one of positions 1 to 5 and ending with an amino acid in any one of positions 40 to 104 or a homologous sequence, its use as a carrier for a conjugate, particularly in combination with a polysaccharide, and a process for producing the peptide as well as vaccines comprising said peptide.

Abstract: Immununological compositions and methods for making and using them. The compositions contain at least one antigen and at least one lipoprotein and optionally an adjuvant. The lipoprotein can itself be antigenic or immunogenic. The antigen can be influenza HA and the lipoprotein a recombinantly expressed product having an OspA leader for lipidation and PspA for the protein portion. The antigen can be OspC and the lipoprotein OspA. The components of the composition are co-administered. A potentiated immunological response is obtained by the compositions and methods.

Abstract: A method is provided for identifying, isolating, and producing htrB mutants of gram-negative bacterial pathogens. The method comprises mutating the htrB gene of a gram-negative bacterial pathogen so that there is a lack of a functional HtrB protein, resulting in a mutant that lacks one or more secondary acyl chains and displays substantially reduced toxicity as compared to the wild type strain. Also, the present invention provides methods for using a vaccine formulation containing the htrB mutant, or the endotoxin isolated therefrom, to immunize an individual against infections caused by gram-negative bacterial pathogens by administering a prophylactically effective amount of the vaccine formulation.

Abstract: The present invention pertains generally to novel Neisseria meningitidis serogroup B glycoconjugates. More particularly, the invention pertains to glycoconjugates formed from a Neisseria meningitidis serogroup B capsular oligosaccharide derivative (MenB OS derivative) in which sialic acid residue N-acetyl groups are replaced with N-acyl groups. The invention also pertains to vaccine formulations containing the glycoconjugates, methods of making the vaccine formulations, and methods of using the vaccine formulations to treat or prevent Neisseria meningitidis serogroup B or E. coli K1 disease in a mammalian subject.

Abstract: The invention provides an improved Mycoplasma hyopneumoniae bacterin vaccine composition, which advantageously provides immunity from infection after a single administration. The composition comprises an inactivated Mycoplasma hyopneumoniae bacterin and an adjuvant mixture, which, in combination, provide immunity from Mycoplasma hyopneumoniae infection after a single administration, and elicit an immune response specific to Mycoplasma hyopneumoniae bacterin and including cell-mediated immunity and local (secretory IgA) immunity. In a preferred embodiment, the adjuvant mixture comprises an acrylic acid polymer, most preferably CARBOPOL®, and a mixture of a metabolizable oil such as one or more unsaturated terpene hydrocarbons, preferably squalene or squalane, and a polyoxyethylene-polyoxypropylene block copolymer such as PLURONIC®. The vaccine composition may optionally include a preservative, preferably thimerosol and/or EDTA.

Abstract: Immunogenic compositions and subunit vaccines for dental caries are described which comprise peptide subunits of glucan binding protein-B and peptide subunits of glucan binding protein-B in combination with peptide subunits of glucosyltransferase. Methods of provoking an immune response to S. mutans glucan binding protein-B or glucosyltransferase. Methods of immunizing a mammal against dental caries are also described, along with antibodies which bind particular epitopes of glucan binding protein-B or glucosyltransferase.

Abstract: The present invention provides methods for making compositions including siderophore receptor polypeptides and porins from gram negative microbes. The methods include providing a gram negative microbe, disrupting the microbe, solubilizing the disrupted microbe, and isolating the polypeptides.

Abstract: The present invention provides methods for treating an animal having a high somatic cell count. The methods include administering compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter.

Abstract: Vaccines and methods against M. haemolytica infections in cattle. The vaccine compositions include a recombinant outer membrane protein of M. haemolytica designated PlpE and/or subunits thereof, alone or in combination with other antigenic components, and a carrier or diluent. The methods involve administering an effective immunizing amount of the vaccines to susceptible bovine.

Abstract: The present invention provides compositions including at least two siderophore receptor polypeptides and at least two porins from a gram negative microbe, and preferably, lipopolysaccharide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of makino and methods of using such compositions.

Abstract: The present invention provides methods for treating an animal for low milk production. The methods include administering compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter.

Abstract: The invention is directed to a suppository based vaccine delivery system for immunizing against urogenital and anorectally transmitted infectious disease in humans and animals and a method for treating the same. More particularly, this invention is directed to a suppository based vaccine delivery system for the prophylaxis against or treatment of urogenital or anorectal transmitted infectious diseases, such as from viral or microbial pathogens.

Abstract: This invention provides isolated nucleic acids encoding polypeptides comprising amino acid sequences of streptococcal matrix adhesion (Ema) polypeptides. The invention provides nucleic acids encoding Group B streptococcal Ema polypeptides EmaA, EmaB, EmaC, EmaD and EmaE. The present invention provides isolated polypeptides comprising amino acid sequences of Group B streptococcal polypeptides EmaA, EmaB, EmaC, EmaD and EmaE, including analogs, variants, mutants, derivatives and fragments thereof. Ema homologous polypeptides from additional bacterial species, including S. pneumoniae, S. pyogenes, E. faecalis and C. diptheriae are also provided. Antibodies to the Ema polypeptides and immunogenic fragments thereof are also provided. The present invention relates to the identification and prevention of infections by virulent forms of streptococci.

Abstract: An immunogenic complex, essentially consisting of neisserial outer membrane protein proteosomes hydrophobically complexed to native purified bacterial lipopolysaccaride and formulated in accordance with the current invention for mucosal delivery such as via the oral or intranasal route is used as a vaccine. Specifically, a vaccine using shigella lipopolysaccharides complexed to proteosomes for such mucosal administration induces IgG and IgA antibodies in sera and in respiratory and intestinal fluids. Furthermore, such antibodies are associated with protection against shigella infection and these vaccines are herein demonstrated to protect against mucosal infection with shigella.

Abstract: Mycobacterium tuberculosis protein having a molecular weight of 28 779 Da, and hybrid proteins containing at least portions of its sequence. These proteins may in particular be used in vaccines or for the detection of specific tuberculosis antibodies.

Abstract: The present invention provides glucan-based compositions and methods for stimulating an immune response against mutans streptococci components and vaccines and methods for the treatment and prevention of dental caries. In a preferred embodiment, a glucan polymer, preferably WSG, is covalently bound to one or more T cell-dependent antigens to form a conjugate vaccine. The T cell-dependent antigen preferably contains epitopes of one or more mutans streptococcal proteins, such as a glucosyltransferase. Moreover, one or more moieties, including haptens, may be conjugated to the glucan-T cell-dependent composition. In a preferred embodiment, these moieties are peptides which contain immunogenic epitopes corresponding to components of a mutans streptococcus.

Abstract: A method of inducing either a TH1 polarized immune response, a TH2 polarized immune response or a combined TH1 and TH2 response to an antigen and associated vaccine formulations are disclosed. A method is provided for inducing a polarized TH1 response by parenteral administration of microparticles sized such that at least 50% of the microparticles are less than 5 ?m. The microparticles containing antigen entrapped or encapsulated by a biodegradable polymer. Additionally, a method is provided for inducing a polarized TH2 response by parenteral administration of nanoparticles sized such that at least 50% of the nanoparticles are less than 600 nm, the nanoparticles containing antigen entrapped or encapsulated by a biodegradable polymer. Vaccine formulations containing the B. pertussis antigens PTd, FHA or a combination of PTd and FHA are provided.

Abstract: Methods and compositions for the treatment of microbial infection, and in particular meningococcal disease, comprise a commensal Neisseria or an extract of a commensal Neisseria. Further methods and compositions comprise conimensal Neisseria which express genes from virulent strains of Neisseria and/or heterologous gene products from non-Neisserial sources. Such compositions are used in vaccine preparations for the treatment of microbial infection.

Abstract: Recombinant hybrid streptococcal M protein antigens are provided which elicit protective antibodies against Group A streptococci and prevent rheumatic fever. Recombinant hybrid genes which encode the antigen are provided. Vaccine compositions and methods of administering the compositions are provided to elicit immunity against Group A streptococci.

Abstract: Pertactin (PRN) is an outer membrane protein expressed by Bordetella pertussis, Bordetella parapertussis, and Bordetella bronchiseptica, which induces protective immunity to Bordetella infections. The immunodominant and immunoprotective epitopes of pertactin include two repeated regions, I and II. Comparison of these two repeated regions showed the pertactin of B. parapertussis is invariant, whereas the pertactin of B. pertussis varies mostly in region I and B. bronchiseptica varies in both the repeated regions I and II. Compositions containing pertactins and pertactin fragments containing variant sequences in these regions are useful as immunogenic compositions.

Abstract: Methods for improving binding of a proteinaceous substance to cell-wall material of a Gram-positive bacterium are disclosed. The proteinaceous substance includes an AcmA cell-wall binding domain, homolog or functional derivative thereof. The method includes treating the cell-wall material with a solution capable of removing a cell-wall component such as a protein, lipoteichoic acid or carbohydrate from the cell-wall material and contacting the proteinaceous substance with the cell-wall material.

Abstract: The present invention provides a novel composition which is a hybrid heat labile enterotoxin comprising the A-subunit of the heat labile toxin of Escherichia coli (LT-A) and the B-subunit of the cholera enterotoxin of Vibrio cholerae (CT-B). The hybrid toxin is designated LT-A/CT-B. The LT-A subunit, the CT-B subunit, or both subunits of the hybrid toxin may be mutant subunits, e.g., differing from wild-type subunits by amino acid substitutions, deletions or additions. Also provided are methods of using the novel LT-A/CT-B comprising compositions of the invention as adjuvants for vaccines, methods of making the LT-A/CT-B hybrid holotoxin, and kits.

Abstract: The present invention is drawn to an immunogenic composition comprising OspC polypeptides from Lyme Disease causing Borrelia. In one embodiment, the immunogenic composition of the present invention comprises at least one OspC polypeptide or immunogenic fragment thereof from each of Borrelia burgdorferi OspC families A, B, I and K. In another embodiment, the immunogenic composition of the present invention comprises at least one OspC polypeptide or immunogenic fragment thereof from each of Borrelia afzelii OspC families A and B.

Abstract: The present invention provides a method of treating or preventing inflammation in a subject, comprising administering to the subject an effective amount of cholera toxin subunit B. The present invention also provides a method of decreasing the activity of interferon gamma in a subject, comprising administering to the subject an effective amount of cholera toxin subunit B. Further provided is a method of decreasing the activity of IL-12 in a subject, comprising administering to the subject an effective amount of cholera toxin subunit B. Additionally, the present invention provides a method of treating or preventing a Th1 T-cell mediated autoimmune disorder in a subject, comprising administering to the subject an effective amount of cholera toxin subunit B.

Abstract: The invention provides an improved Mycoplasma hyopneumoniae bacterin vaccine composition, which advantageously provides immunity from infection after a single administration. The composition comprises an inactivated Mycoplasma hyopneumoniae bacterin and an adjuvant mixture, which, in combination, provide immunity from Mycoplasma hyopneumoniae infection after a single administration, and elicit an immune response specific to Mycoplasma hyopneumoniae bacterin and including cell-mediated immunity and local (secretory IgA) immunity. In a preferred embodiment, the adjuvant mixture comprises an acrylic acid polymer, most preferably CARBOPOL®, and a mixture of a metabolizable oil such as one or more unsaturated terpene hydrocarbons, preferably squalene or squalane, and a polyoxyethylene-polyoxypropylene block copolymer such as PLURONIC®. The vaccine composition may optionally include a preservative, preferably thimerosol and/or EDTA.

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: A method of immunization, and compositions therefor, are provided for substantially preventing or reducing the symptoms of at least one infectious disease and at least one chronic immune mediated disorder. An immunogenic challenge which supplements the normal childhood immunization schedule can help ensure the proper maturation of the immune system and prevent the development of chronic immune mediated disorders, such as immune-mediated diabetes or SLE.

Abstract: An isolated, biologically active 33 kDa hemagglutinin purified from the type A Clostridium botulinum neurotoxin complex and its uses are described.

Abstract: Immunological compositions and methods for making and using them. The compositions contain at least one antigen and at least one lipoprotein and optionally an adjuvant. The lipoprotein can itself be antigenic or immunogenic. The antigen can be influenza HA and the lipoprotein a recombinantly expressed product having an OspA leader for lipidation and PspA for the protein portion. The antigen can be OspC and the lipoprotein OspA. The components of the composition are co-administered. A potentiated immunological response is obtained by the compositions and methods.

Abstract: Inactivated scours vaccines for immunization and protection of bovine animals from disease caused by infection with bovine rotavirus and bovine coronavirus, which comprise and effective amount of at least one inactivated viral strain are described. Polyvalent inactivated vaccines further comprising an effective amount of an antigenic component which is protective against one or more additional pathogenic organisms or viruses are also disclosed. Said vaccines are prepared from one or more strains of rota- and coronavirus, C. perfringens Type C bacteria and E. coli bacteria, and combinations thereof. Preferably, a polyvalent inactivated vaccine is provided for parenteral administration. Passive immunity is achieved in neonatal calves via immunization of pregnant cows prior to birth.

Abstract: The invention relates to a method for making an inactivated vaccine of Mycoplasma hyopneumoniae by inactivating the bacteria with Thimerosal. The resulting bacterin is mixed with an adjuvant of aluminum hydroxide and DEAE dextran and injected into pigs. The resulting bacterin and adjuvant mixture can also be mixed with other bacteria such as Bordetella and Pasteurella, for further adjuvant effect. Protective immunity against mycoplasmal pneumonia is elicited in swine using these vaccines.