Abstract: The present invention describes a combined vaccine that offers broad protection against meningococcal disease caused by the pathogenic bacteria Neisseria meningitidis. The vaccine is comprised of four distinct polysaccharide-protein conjugates that are formulated as a single dose of vaccine. Purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y are chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains in children as well as adults.

Abstract: A vaccine is provided wherein a polypeptide or combination of peptides from M. tuberculosis is administered to a subject to elicit an immune response. The polypeptide vaccine is administered as part of a prime-boost strategy with BCG vaccine to increase the immunoprotection in a subject such that prevention or elimination of disease is achieved. Finally, a pharmaceutical package is provided that encompasses a polypeptide vaccine for M. tuberculosis that when administered to a subject elicits immunoprotection.

Abstract: The present invention describes a combined vaccine that offers broad protection against meningococcal disease caused by the pathogenic bacteria Neisseria meningitidis. The vaccine is comprised of four distinct polysaccharide-protein conjugates that are formulated as a single dose of vaccine. Purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y are chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains in children as well as adults.

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: Combination vaccine compositions as well as methods for their manufacture have a relatively low amount of antigen and/or a relatively low amount of aluminium, but they can nevertheless have immunogenicity which is comparable to combination vaccines with a relatively high amount of antigen and/or a relatively high amount of aluminium. Aluminium-free combination vaccine compositions are also provided e.g. compositions which are adjuvanted with an oil-in-water emulsion adjuvant.

Abstract: Formulation of vaccine antigens, containing as main components: a—) one or several DNA expressing one or several proteins in the immunized individuals and b—) a viral antigen, in appropriate proportions. Development of new formulations, minimizing the number of components that enhance and diversify the spectrum of immune response against different pathogenic entities and generating combined vaccines against pathogens. These formulations can be applied in the pharmaceutical industry for preventive and-or therapeutic use in human.

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: Disclosed are compositions, kits, and methods for inducing an immune response against disease. The dosage of antigen contained or utilized in the presently disclosed compositions, kits, and methods is substantially lower than dosages conventionally used in the field. The compositions, kits, and methods may be utilized to induce a cell-mediated response, such as a T-helper cell response, and/or a humoral response against a pathogen or a disease. In some embodiments, the compositions, kits, and methods may be utilized to induce preferentially a Th1 response versus other types of immune responses such as a Th2 response.

Abstract: A recombinant avian infectious coryza vaccine and a process for preparing the same are provided. A process for preparing a recombinant avian infectious coryza vaccine which comprises step of constructing E. coli that may produce as an inclusion body a fusion peptide consisting of peptides derived from outer-membrane protein of Avibacterium paragarinarum serotype A and serotype C, step of culturing said E. coli and collecting and purifying inclusion body from culture, and step of preparing a preparation comprising said purified inclusion body, and an avian infectious coryza vaccine comprising as an active ingredient the fusion peptide. A linker sequence may be inserted between the respective peptides comprising the fusion peptide. For the peptide derived from the serotypes A and C, an amino acid sequence region of Region 2 or its vicinity responsible for protection from infection may be used.

Abstract: The present invention relates to a product named “immunogenical complex”, which comprises an adjuvant characterized by solid particles of highly ordinated nanostructured mesoporous silica, preferably, SBA-15 Silica, and vaccinal antigens of several natures, encapsulated in the referred to adjuvants. The immunogenical complex of the present invention allows the presentation of the antigens that compose it to lymphocytes, in a safe, gradual and extended way, which leads to a more efficient immunological memory, increases the immunogenicity of the antigen and improves the production of antibodies. This ensures an efficient immunological protection with fewer amounts of antigens and/or less repetitions of vaccinal doses. In addition, the characteristics of the immunogenical complex of the present invention promotes effective immunity induction, homogeneous in “god and bad respondent” individuals.

Abstract: The methods and compositions of the present invention are directed to a vaccine against Vibrio cholerae comprised of V. cholerae outer membrane vesicles (OMVs). Such vaccines are relatively stable, facilitating distribution. Inventive methods generally include administration of a vaccine against Vibrio cholerae by intranasal, intraperitoneal, oral or intragastric routes. Such vaccines confer immunity to the individual, and when administered to pregnant subjects, can be conferred to the offspring of individuals.

Abstract: The present invention relates to the field of vaccines for protecting against tetanus, and in particular processes for the production of vaccines comprising tetanus toxoid adsorbed onto aluminium salts. Processes are provided whereby tetanus toxoid is absorbed onto aluminium salt adjuvant having defined characteristics for optimal results.

Abstract: The present invention provides a composition and an improved single dose vaccine against E. rhusiopathiae and an improved single dose vaccine against E. rhusiopathiae and H. parasuis which provides one or more of the following: 1) confers effective immunity against E. rhusiopathiae and/or H. parasuis; 2) decreases the risk of developing clinical signs of E. rhusiopathiae and/or H. parasuis infection; 3) induces an immune response against E. rhusiopathiae and/or H. parasuis; and 4) has a DOI against E. rhusiopathiae and/or H. parasuis of at least four months. The composition or E. rhusiopathiae vaccine as well as the combined E. rhusiopathiae-H. parasuis composition or vaccine each includes a bacterial component of inactivated E. rhusiopathiae bacteria and a suitable adjuvant. The combined E. rhusiopathiae-H. parasuis composition or vaccine further includes an amount of H. parasuis antigen. The vaccines can be administered to animals in any conventional manner.

Abstract: The invention provides a diphtheria, tetanus and pertussis vaccine comprising a low dose of each of diphtheria toxoid (D), tetanus toxoid (T), pertussis toxin (PT), filamentous haemagglutinin (FHA) and pertactin (69K). The vaccine maintains an ability to prevent pertussis while showing exceptionally low reactogenicity. Combination vaccines comprising additional antigens are also provided.

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: 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: Bordetella pertussis p69 antigen is purified by immobilized metal affinity chromatography.

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 invention provides compositions (e.g., peptide compositions) useful for the detection of antibodies that bind to Borrelia antigens. The peptide compositions comprise polypeptide sequences comprising variants in the IR6 domain of the Borrelia VlsE protein. The invention also provides devices, methods, and kits comprising such peptide compositions and useful for the detection of antibodies that bind to Borrelia antigens and the diagnosis of Lyme disease.

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 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 relates to a pharmaceutical vaccine composition comprising: (a) a pathogen-derived antigen selected from the group consisting of Mycobacterium tuberculosis antigen, Bacillus anthracis antigen, HAV (hepatitis A virus) antigen, HBV (hepatitis B virus) antigen, HCV (hepatitis C virus) antigen, HIV (human immunodeficiency virus) antigen, influenza virus antigen, HSV (herpes simplex virus) antigen, Hib (Haemophilus influenzae type b) antigen, Neisseria meningitidis antigen, Corynebacterium diphtheriae antigen, Bordetella pertussis antigen, Clostridium tetani antigen and Varicella virus antigen; (b) a deacylated non-toxic LOS (lipooligosaccharide); and (c) a pharmaceutically acceptable carrier.

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: 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: The present invention relates to synergistic immunogenic compositions for preventing whooping cough and infections caused by Streptococcus pneumoniae. Additionally, the compositions according to the present invention may protect against infections caused by other pathogenic agents by means of a synergistic combination of antigens thereof. In particular, the present invention provides synergistic immunogenic compositions that comprise at least one cell antigen of inactivated Bordetella pertussis and at least one protein antigen comprising one or more surface proteins A (PspA) of Streptococcus penumoniae or fragments thereof. The present invention further provides synergistic immunogenic compositions comprising at least one cell antigen of inactivated Bordetella pertussis, at least one protein antigen comprising one or more surface proteins A (PspA) of Streptococcus penumoniae or fragments thereof, and one or more diphtheria and/or tetanus toxins.

Abstract: The invention improves TdaP vaccines by including a TLR agonist in them. This agonist can provide stronger protection, longer-lasting protection, and/or can reduce the amount of antigen which is required to achieve a particular immune response.

Abstract: The invention provides, inter alia, immunogenic compositions comprising a first antigen, at least two adjuvants, wherein a first adjuvant comprises a polymer derived from poly(lactides) and/or poly(lactide-co-glycolides), and wherein a second adjuvant comprises an imidazoquinoline, wherein said first antigen is encapsulated within, adsorbed or conjugated to, co-lyophilized or mixed with said first adjuvant, and a pharmaceutically acceptable excipient, wherein said composition elicits a cellular immune response when administered to a vertebrate subject. The invention also provides methods of producing immunogenic compositions, methods for producing a cytotoxic-T lymphocyte (CTL) response in a vertebrate subject, and methods of immunization.

Abstract: This invention provides an isolated nucleic acid encoding a polypeptide comprising amino acid sequences of a streptococcal matrix adhesion E (EmaE) polypeptide. Antibodies to the EmaE polypeptide and immunogenic fragments thereof are also provided. This invention provides pharmaceutical compositions, immunogenic compositions, vaccines, and diagnostic and therapeutic methods of use of the isolated polypeptide, antibodies thereto, and nucleic acids.

Abstract: Conjugated meningococcal capsular saccharides will be introduced into immunization schedules in the near future, but the phenomenon of “carrier suppression” must first be addressed, particularly where multiple conjugates are to be used. In the invention, tetanus toxoid is used as the carrier protein, even where multiple meningococcal conjugates are administered at the same time and where a patient has previously been exposed to the carrier protein, either in the form of a previous immunogen (e.g. in a DTP vaccine) or as a previous carrier protein (e.g. in a Hib or pneumococcal conjugate vaccine). The invention provides a method for immunizing a patient, comprising administering multiple conjugates of meningococcal capsular saccharides, wherein each conjugate comprises a tetanus toxoid carrier protein, and the capsular saccharide, and wherein the patient has been pre-immunized with a tetanus toxoid.

Abstract: A composition and dosage regime including a vaccine and levamisole for the treatment of clostridial diseases and helminthiasis. New methods of administration relating to particular dosage regimes of such a composition are also claimed.

Abstract: The present invention relates to a fermentation medium for cultivating Corynebacterium diphtheriae. The present invention also relates to the use of the fermentation medium in processes for obtaining diphtheria toxin from the Corynebacterium diphtheriae bacteria being cultivated and the preparation of vaccines using the diphtheria toxin obtained in the processes. The present invention further relates to a purification and detoxification processes specifically adapted for preparing a diphtheria toxoid for inclusion into a vaccine.

Abstract: The invention provides proteins from group B streptococcus (Streptococcus agalactiae) and group A streptococcus (Streptococcus pyogenes), including amino acid sequences and the corresponding nucleotide sequences. Data are given to show that the proteins are useful antigens for vaccines, immunogenic compositions, and/or diagnostics. The proteins are also targets for antibiotics.

Abstract: The present invention provides improved vaccine compositions having enhanced immunogenicity and methods of using same. The compositions and methods include immunogenic conjugates containing peptide carriers derived from heat shock protein 60 (HSP60). The known synthetic peptide carrier, p458, provides significantly improved immunogenicity when provided as a multimeric conjugate comprising a plurality of peptide carrier units conjugated to each antigen. Cell vaccine compositions comprising antigen presenting cells loaded with multimeric p458 conjugates are also provided.

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 relates to therapeutic and prophylactic methods for treating or preventing an infectious disease in a subject by stimulating or enhancing an immune response against an infectious agent causing the disease. The methods comprise administering to the subject a plurality of compositions, each composition being administered to a different site of the subject, wherein each site is, or substantially drains to, an anatomically distinct lymph node, a group of lymph nodes, a nonencapsulated cluster of lymphoid tissue, or the spleen. Each composition comprises at least one antigenic molecule having one or more epitopes of the same infectious agent or a strain thereof. The antigenic molecules of each composition comprise in aggregate a set of epitopes distinct from that of any other composition that is administered to the subject.

Abstract: An immunogenic regimen is provided. The regimen involves sequential administration of a recombinant adenoviral vector and a recombinant adeno-associated viral vector, each of which delivers a heterologous expression cassette encoding the same immunogenic product, or a cross-reactive immunogenic product. Also provided are products containing the vectors for use in the regimen of the invention.

Abstract: The present invention pertains to the use of Haemophilus parasuis bacteria of serotype 5 expressing an iron-restriction protein visible on a Western-blot when reacted with serum of a convalescent animal which has recovered from an infection by Haemophilus parasuis bacteria of serotype 4, the said protein not being visible on a Western-blot when Haemophilus parasuis bacteria of serotype 5 grown under iron-replete conditions, are reacted under the same conditions, in a vaccine to protect a subject animal against a disorder arising from Haemophilus parasuis serotype 4 bacteria.

Abstract: A composition comprising (a) Neisseria meningitidis serogroup B outer membrane vesicles (OMVs), and (b) an immunogenic component selected from other Neisseria proteins, or immunogenic fragments thereof. Component (b) preferably includes a protein from a different NmB strain from that from which the OMV of component (a) is derived. The OMVs are preferably obtained by deoxycholate extraction. Optionally, the composition may also comprise a protective antigen against other pathogens.

Abstract: The invention relates to Salmonella typhi Ty21a comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2 and species homologs thereof; b) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2, and species homologs thereof; and c) DNA encoding a O antigen biosynthesis gene product that hybridizes under moderately stringent conditions to the DNA of (a) or (b); and related sequences, compositions of matter, vaccines, methods of using, and methods of making.

Abstract: The invention provides methods of modulating an immune response to a second antigen which entail administration of a first antigen and an immunostimulatory polynucleotide. Modulation of the immune response is generally manifested as stimulation of a Th1 response.

Abstract: Vaccine formulations effective against Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA) are disclosed, as well as methods of using the vaccine formulations in the treatment, prevention and prophylaxis of Staphylococcus aureus infections in a subject.

Abstract: The present invention relates to compositions comprising at least one purified PorA protein antigen and at least one purified FetA protein antigen. In particular, said PorA/FetA antigens are antigenically variable antigens comprising the variable regions of PorA/FetA. Specific combinations of PorA/FetA epitopes are presented for example in Table 3. The invention also relates to methods of immunization comprising administering said compositions, and to methods for producing compositions. Preferably the compositions are purified protein compositions. Preferably the compositions are vaccine compositions.

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: Bordetella pertussis p69 antigen is purified by immobilised metal affinity chromatography.

Abstract: A composition comprising (a) Neisseria meningitidis serogroup B outer membrane vesicles (OMVs), and (b) an immunogenic component selected from other Neisseria proteins, or immunogenic fragments thereof. Component (b) preferably includes a protein from a different NmB strain from that from which the OMV of component (a) is derived. The OMVs are preferably obtained by deoxycholate extraction. Optionally, the composition may also comprise a protective antigen against other pathogens.

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 application relates to a composition comprising extracellular membrane vesicles derived from indoor air. In addition, the present application provides a method for diagnosing, preventing and/or treating an inflammatory respiratory disease, lung cancer and the like using the extracellular membrane vesicles. In detail, the present application involves injecting extracellular membrane vesicles present in indoor air into an animal in order to prepare an animal respiratory disease model, and enables the search and/or discovery of drug candidates for preventing or treating respiratory diseases using the animal model.

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 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 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.