Abstract: The present invention encompasses vaccines or compositions comprising the chimeric KSAC protein that possesses immunogenic and protective properties, and methods of use including administering to an animal the antigenic KSAC protein thereof to protect animals. The invention also encompasses methods for making and producing the soluble, disaggregated, refolded or active proteins from inclusion bodies produced from prokaryotes or eukaryotes.

Abstract: An isolated protein or peptide selected from the group consisting of Bordetella colonization factor A (BcfA) protein and antigenic fragments thereof is described, along with an isolated nucleic acid encoding the same, antibodies that bind to the same, methods of producing an immune response in a mammalian subject in need thereof by administering the proteins, peptides or antibodies, and pharmaceutical compositions comprising the same.

Abstract: Provided herein are methods for immunizing children under six months of age by administering to the child a pharmaceutical composition comprising at least one antigen derived from an influenza virus.

Abstract: An aqueous composition having increased protein stability is obtained by: a. determining a pH at which the protein has stability at the desired temperature; b. adding to the composition at least one displacement buffer wherein the displacement buffer has a pKa that is at least 1 unit greater or less than the pH of step (a); and c. adjusting the pH of the composition to the pH of step (a); wherein the aqueous composition does not comprise a conventional buffer at a concentration greater than about 2 mM and wherein the conventional buffer has a pKa that is within 1 unit of the pH of step (a).

Abstract: The present invention relates to the field of vaccines for protecting against polio, and in particular to combination vaccines for protecting against polio, diphtheria, tetanus, and pertussis diseases. Specifically, vaccines comprising reduced dose inactivated poliovirus are provided.

Abstract: Described are acellular pertussis (aP) vaccine compositions comprising Bordetella pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), and fimbriae types 2 and 3 (FIM), and optionally pertactin (PRN), wherein FIM is present in an amount of 12-100 ?g per human dose.

Abstract: A vaccine adjuvant composition comprising: a lipid selected from the group consisting of: dipalmitoyl phosphatidicholine (DPPC), dipalmitoyl phosphatidylglycerol (DPPG), dioleoyl phosphatidylcholine (DOPC), and cholesterol and containing a positively or negatively charged lipid with associated/entrapped protein antigen.

Abstract: In one aspect, the present disclosure provides compounds of formulae (I) and (II). In another aspect, a compound of formula (I) or (II) is formulated into compositions with an antigen, optionally with a vesicle. In some embodiments, compositions are administered intramuscularly.

Abstract: The present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: Provided herein are methods and compositions for stabilization of active agents. The active agents are distributed, mixed or embedded in a silk fibroin matrix, thereby retaining the bioactivity of the active agents upon storage and/or transportation. In some embodiments, the storage-stable vaccine-silk compositions are also provided herein.

Abstract: The invention provides compositions comprising liposomes, an antigen capable of inducing a humoral immune response, a carrier comprising a continuous phase of a hydrophobic substance, and an adjuvant that activates or increases the activity of TLR2. The invention also provides uses for such compositions in inducing a humoral response and methods for their use in the treatment of a disease, disorder or ailment ameliorated by a humoral immune response.

Abstract: The present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: The invention relates to hyperbaric devices for inactivating microorganisms and viruses while retaining their immunogenicity and for making and producing the soluble, disaggregated, refolded or active immunogenic or therapeutic proteins from inclusion bodies produced from prokaryotes or eukaryotes. The invention encompasses hyperbaric methods for inactivating pathogenic organisms, and methods for producing vaccine compositions using the inactivated pathogens. The hyperbarically inactivated microorganisms are safer and more immunogenic than chemically inactivated microorganisms. Similarly, the solubilized proteins have superior properties compared to more heavily aggregated proteins, including reduced non-specific immune reactions.

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

Abstract: The invention provides BASB232 polypeptides and polynucleotides encoding BASB232 polypeptides and methods for producing such polypeptides by recombinant techniques. Also provided are diagnostic, prophylactic and therapeutic uses. The invention further provides immunogenic compositions comprising a plurality of antigens selected from at least two different categories of antigen, having different functions within Bordetella. Examples of such categories of antigen are autotransporter proteins, iron acquisition proteins, lipoproteins, adhesins and toxins/invasins.

Abstract: The present invention is related with the field of Biomedicine. It comprises the engineering of the Pertactin protein (Prn) and using it as part of bacterial vaccines, and more precisely, as part of acellular vaccines against Bordetella pertusis. The engineered Prn molecules comprise on their structure polimorfisms from different B. pertussis strains, and induce immune responses with protective capacity and opsonophagocytic activity when assayed as vaccines, higher than that generated by other pre-existing vaccines. The engineered Prn variants of the present invention are applicable in human and veterinary medicine.

Abstract: The present invention relates to the field of vaccines and in particular to combination vaccines and co-administration schedules. The present inventors disclose that overuse of CRM in paediatric vaccines can result in bystander immune interference to certain antigens and provide solutions to this problem.

Abstract: The present invention relates to a life attenuated Bordetella pertussis vaccine which is deficient for tracheal cytotoxin (TCT), pertussis toxin (PTX), and dermonecrotic toxin (DNT) for prophylaxis or treatment of an allergen-driven airway pathology.

Abstract: An objective of the present invention is to provide a whole-cell bacterial vaccine composition for preventing whooping cough caused by Bordetella parapertussis, comprising whole cells, whole-cell homogenate, or cell lysate of B. parapertussis as an immunogen, and methods for producing them.

Abstract: Immunogenic compositions are described herein which comprise microparticles that further comprise a biodegradable polymer. The microparticle compositions also comprise a cationic polysaccharide and an immunological species selected from an antigen, an immunological adjuvant and a combination thereof. Also described are methods of making such compositions and methods of administering such compositions. Methods of modulating the release rate of immunological species from microparticles are also described. These methods comprise varying the ratio of the cationic polysaccharide relative to the biodegradable polymer within the microparticles.

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

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

Abstract: The invention relates to compositions and vaccines that include a mutated Bordetella strain for treating or preventing an influenza infection in a mammal. In addition, the invention further provides methods for protecting a mammal against infection by influenza and/or eliciting an immune response against an influenza virus in a mammal using the composition or vaccine.

Abstract: Various nucleic acid-based matrixes are provided, comprising nucleic acid monomers as building blocks, as well as nucleic acids encoding proteins, so as to produce novel biomaterials. The nucleic acids are used to form dendrimers that are useful as supports, vectors, carriers or delivery vehicles for a variety of compounds in biomedical and biotechnological applications. In particular, the macromolecules may be used for the delivery of drugs, genetic material, imaging components or other functional molecule to which they can be conjugated. An additional feature of the macromolecules is their ability to be targeted for certain organs, tumors, or types of tissues. Methods of utilizing such biomaterials include delivery of functional molecules to cells.

Abstract: Adjuvant for mucosal vaccines which modulates the effects of substances, including vaccine antigens in contact with mucosal body surfaces.

Abstract: The current invention provides new Gram negative polypeptides exhibiting lipid A 3-O-deacylase activity and are capable of modifying and/or detoxifying gram negative LPS. The present invention also provides Gram negative bacteria, Gram negative bacterial lipopolysaccharides (LPS) and compositions comprising LPS, which are provided with or treated with a 3-O-deacylase activity according to the invention and which may be used for pharmaceutical and/or veterinary purposes, in particular for the preparation of whole cell or acellular vaccines against pathogenic Gram negatives such as Bordetella pertussis, Bordetella parapertussis and Bordetella bronchiseptica.

Abstract: Liquid pharmaceutical compositions for administration to a mucosal surface, including a therapeutic agent and a pectin with a low degree of esterification are described. Such compositions gel, or can be adapted to gel, at the site of application in the absence of an extraneous source of divalent metal ions.

Abstract: The invention provides novel adjuvants and pharmaceutical composition comprising of an adjuvant alone. The invention also provides novel vaccine compositions comprising of an antigen and a novel adjuvant. The novel adjuvant as per present invention is farnesoid-X-receptor (FXR) antagonist. The invention also relates to an adjuvant for variety of antigens. The adjuvant improves antibody production specific to incorporated antigen. The adjuvant also induces cell mediated immune response.

Abstract: The present invention relates to a surface exposed protein, which can be detected in Moraxella catarrhalis, having an amino acid sequence as described in SEQ ID NO: 1, an apparent molecular weight of 200 kDa and a capacity of selectively binding membrane bound or soluble IgD, to an immunogenic or IgD-binding fragment of said surface exposed protein, and to an immunogenic and adhesive fragment of said surface exposed protein. DNA segments, vaccines, plasmids and phages, non human hosts, recombinant DNA molecules and plants, fusion proteins and polypeptides and fusion products are also described. A method of detecting IgD, a method of separating IgD, a method of isolation of a surface exposed protein of Moraxella catarrhalis and a method for treatment of an autoimmune disease are also disclosed.

Abstract: The present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: The invention provides, inter alia, immunogenic compositions that comprise (a) a first antigen, (b) at least first and second adjuvants, wherein the first adjuvant comprises microparticles and wherein the second adjuvant comprises an imidazoquinoline compound, and (c) a pharmaceutically acceptable excipient, which compositions elicits an immune response when administered to a vertebrate subject. The invention also provides methods of producing immunogenic compositions and methods for using immunogenic compositions (e.g., for treatment), among other benefits.

Abstract: The present invention is related with the field of Biomedicine. It comprises the engineering of the Pertactin protein (Prn) and using it as part of bacterial vaccines, and more precisely, as part of acellular vaccines against Bordetella pertusis. The engineered Prn molecules comprise on their structure polimorfisms from different B. pertussis strains, and induce immune responses with protective capacity and opsonophagocytic activity when assayed as vaccines, higher than that generated by other pre-existing vaccines. The engineered Prn variants of the present invention are applicable in human and veterinary medicine.

Abstract: An isolated protein or peptide selected from the group consisting of Bordetella colonization factor A (BcfA) protein and antigenic fragments thereof is described, along with an isolated nucleic acid encoding the same, antibodies that bind to the same, methods of producing an immune response in a mammalian subject in need thereof by administering the proteins, peptides or antibodies, and pharmaceutical compositions comprising the same.

Abstract: The invention relates to an improved vaccine against pertussis wherein mutants of Bordetella pertussis having a modified LPS molecule or the obtainable LPS molecules are used. These mutants or the obtainable LPS molecules may further be used as an adjuvant.

Abstract: The present invention provides a Withania somnifera fraction rich in withanolides and a vaccine comprising a “Withania somnifera fraction” as an adjuvant.

Abstract: Disclosed herein are sterile-filtered lyophilized nanoparticle compositions which contain at least one biodegradable polymer, at least one surfactant, at least one cryoprotective agent and at least one antigen. Also disclosed are methods of making and using such compositions and kits supplying such compositions.

Abstract: An objective of the present invention is to provide a whole-cell bacterial vaccine composition for preventing whooping cough caused by Bordetella parapertussis, comprising whole cells, whole-cell homogenate, or cell lysate of B. parapertussis as an immunogen, and methods for producing them.

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: The invention relates to an immunogenic composition, characterized in that it comprises an adenyl cyclase-hemolysin (AC-Hly) protein, or an immunogenic portion of this AC-Hly, of a strain of Bordetella chosen from B. pertussis, B. parapertussis or B. bronchiseptica, and in that it comprises, in addition, a bacterial extract containing the expression products of the vrg genes of a strain of Bordetella chosen from B. pertussis, B. parapertussis or B. bronchiseptica, or a portion of these expression products which is sufficient to induce an immune response in a host to which the extract might be administered.

Abstract: To provide a method of efficiently separate protective components of Bordetella pertussis. On the basis of differences in adsorbability to calcium phosphate gel formed by adding calcium ions to a Bordetella pertussis culture in the presence of excess phosphate ions, protective components of Bordetella pertussis are separated from the Bordetella pertussis culture. Traditionally, protective components of Bordetella pertussis have been separated using different purification methods for the respective components. According to the present invention, the use of the same means of purification for all subject components makes it possible to purify each component with high efficiency and high recovery rate, an aspect very advantageous for industrial production. It is also possible to efficiently produce an improved purified pertussis component vaccine comprising an effective combination of pertussis filamentous hemagglutinin (FHA), pertactin (PRN, 69K-OMP), pertussis fimbriae (FIM) and pertussis toxin (PT).

Abstract: The invention provides proteins from Staphylococcus aureus, including amino acid sequences and corresponding nucleotide sequences. The proteins are useful for vaccines, immunogenic compositions, diagnostics, enzymatic studies, and as targets for antibiotics.

Abstract: Trichoderma spp. strains with high capacity for fungus biological control in wide ranges of temperature and pH are described, such strains being compatible with each other. Likewise, a process of selection of such strains through molecular markers is described. The described process reduce the number of necessary experiments to determine if a Trichoderma strain, not previously described, can display a biological activity more acceptable than those well known.

Abstract: New pertussis toxin (PT) mutants are described being immunologically active and having reduced or no toxicity, characterized in that at least one of the amino acid residues Glu129, Asp11, Trp26, Arg9, Phe50, Asp1, Arg13, Tyr130, Gly86, Ile88, Tyr89, Tyr8, Gly44, Thr53 and Gly80 of subunit S1 amino acid sequence is deleted and substituted by a different amino acid residue selected in the group of natural amino acids; Bordetella strains capable of providing and secreting said PT mutants and means and methods for obtaining them are also described. The Bordetella strains and the PT mutants produced by them are particularly suitable for the preparation of effective cellular and acellular antipertussis vaccines.

Abstract: Disclosed herein are immunogenic compositions comprising a multilayer film comprising two or more layers of polyelectrolytes, wherein adjacent layers comprise oppositely charged polyelectrolytes. A first layer polyelectrolyte comprises an antigenic polypeptide comprising one or more surface adsorption regions covalently linked to one or more antigenic determinant regions, wherein the antigenic polypeptide and the one or more surface adsorption regions have the same polarity. The immunogenic compositions may be employed in methods of eliciting an immune response in a vertebrate organism.

Abstract: The present invention provides materials and methods to facilitate the pulmonary delivery of therapeutic agents. In some embodiments, agonists of tight junctions (e.g., zonulin agonists) are used in compositions to facilitate the uptake of therapeutic agents from the pulmonary mucosa.

Abstract: The present invention relates to an immuno-therapeutic and prophylactic vaccine comprising monocytes or immature myeloid cells (IMCs) loaded with the ligand of natural killer T cell and an antigen for the prevention and treatment of infectious disease or cancer, more precisely, an immuno-therapeutic and prophylactic vaccine comprising monocytes or IMCs loaded with ?-galactosylceramide (?GalCer), a kind of glycolipid and a natural killer T cell ligand, and antigen. Monocytes or immature myeloid cells (IMCs) therein, which are easily obtainable, unlike dendritic cells, not only induce a significant level of cytotoxic T lymphocyte responses but also have a prophylactic and therapeutic effect on malignant tumor. Therefore, the immuno-therapeutic and prophylactic vaccine of the present invention can be effectively used as an immunotherapeutic agent.

Abstract: The present invention describes derivatized polysaccharide-protein conjugates, a composition comprising one or more of such derivatized polysaccharide-protein conjugates and methods of immunizing human patients with the same. The derivatized polysaccharide-protein conjugates are purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y, derivatized 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.

Abstract: Immunogenic compositions are described herein which comprise microparticles that further comprise a biodegradable polymer. The microparticle compositions also comprise a cationic polysaccharide and an immunological species selected from an antigen, an immunological adjuvant and a combination thereof. Also described are methods of making such compositions and methods of administering such compositions. Methods of modulating the release rate of immunological species from microparticles are also described. These methods comprise varying the ratio of the cationic polysaccharide relative to the biodegradable polymer within the microparticles.

Abstract: Improved vaccine compositions and methods of use thereof are described that elicit production of antibodies in an individual to the individual's own endogenous cholesteryl ester transfer protein (CETP).

Abstract: An immunogenic composition comprising a recombinant protein comprising a Bordetella CyaA, or a fragment thereof, and a peptide that corresponds to a tumor antigen is provided as a cancer treatment. Methods of treatment with this immunogenic composition are also provided. In an embodiment, the therapeutic composition is a treatment for melanoma, and comprises epitopes from the HLA*0201 epitope. These epitopes include Tyr or GnT-V, and are present in the recombinant proteins CyaA-E5-Tyr and CyaA-E5-GnT-V.