Abstract: The present invention provides combination vaccines that comprise an immunological agent effective for reducing the incidence of or lessening the severity of PPE caused by L. intracellularis, and one or more immunological active components effective in treatment and/or prophylaxis of at least one further disease-causing organism for swine. Moreover, the present invention also relates to a kit that comprises an immunological agent effective for reducing the incidence of or lessening the severity of PPE caused by L. intracellularis, and one or more immunological active components effective in treatment and/or prophylaxis of at least one further disease-causing organism for swine.

Abstract: The present disclosure relates to surface proteins of Moraxella catarrhalis and their ability to interact with epithelial cells via cell-associated fibronectin and laminin, and also to their ability to inhibit the complement system. These surface proteins are useful in the preparation of vaccines. The present disclosure also provides peptides interacting with fibronectin, laminin and the complement system.

Abstract: The invention is directed to isolated Tilapia Lake Virus or TiLV, and isolated nucleic acids sequences and polypeptides thereof. The invention also relates to probes and primers, and to antibodies against antigens from TiLV, and use of these reagents for detecting the presence or absence of TiLV in an animal. The invention also relates to iRNAs which target nucleic acid sequences of TiLV. The invention is also related to immunogenic compositions, including antibodies and vaccines, for inducing an immune response against TiLV in an animal. The invention is also related to gene constructs and cells comprising TiLV and isolated nucleic acids sequences and polypeptides thereof for use in developing prophylactic and therapeutic agents.

Abstract: The present disclosure provides immunogenic compositions useful in prevention and treatment of Staphylococcus aureus infection. In particular, the disclosure provides delta toxin and phenol-soluble modulin peptides as well as mutants, fragments, variants or derivatives thereof. The disclosure further provides multivalent oligopeptides, fusion proteins comprising two or more staphylococcal proteins, e.g., DT, PSM, alpha hemolysin, leukocidin, superantigen, or any fragments, variants, derivatives, or mutants thereof fused together as a single polypeptide in any order.

Abstract: The present invention is directed to novel multivalent DNA vaccine compositions for inhibiting/blocking one or more virulence antigenic factors of Yersinia pestis in an individual via compositions containing fusion proteins derived from Yersinia pestis fused to the CD40 ligand. Specifically, it involves the administering of expression vectors carrying transcription units that encode fusion proteins comprising a Yersinia pestis antigenic factor fused to the aminoterminal end of the extracellular domain (ecd) of the CD40 ligand (CD40L). The first antigenic factor is a 30 amino acid region (amino acids 196-226) of LcrV outer protein and the second antigenic factor is a 127 amino acid region (amino acids 22-149) of F1 outer protein. The composition may additionally incorporate two secretable fusion proteins (amino acids 196-226 of LcrV and amino acids 22-149 of F1) or multiple antigenic factors (YpkA, YopD, YscF, YadC, OppA) in an effort to reduce the probability of immunological escape.

Abstract: The present invention relates to immunogenic compositions comprising a Clostridium difficile (C. difficile) polypeptide and an aluminum-free adjuvant.

Abstract: This invention describes novel adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37° C. that can be produced at remarkably low costs. This invention describes novel vaccine compositions and formulations to treat and prevent urinary tract infections caused by gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli. This invention also describes methods of administration of said novel vaccine compositions and formulations and methods of treatment to prevent and treat urinary tract infections caused by gram-negative bacteria including E. coli and multi-drug resistant E. coli.

Abstract: The present invention relates to chimeric protein vaccines and methods of use thereof in the treatment of Staphylococcus aureus. One embodiment of the present invention provides a method of generating an immune response in a mammal, that includes administering to the mammal, a composition having a chimeric protein having at least one of: a portion of a cholera toxin, a portion of a heat-labile toxin, and a portion of a shiga toxin; and an antigen having at least one of: an antigenic material from S. aureus and an antigenic material from a S. aureus-specific polypeptide.

Abstract: Recombinant Mycobacteria (rMyc) which contain sequences encoding a heparin-binding hemagglutinin (HBHA) fusion protein are provided, as are methods of making and using the rMyc and the fusion protein. The fusion protein includes an amino terminal mycobacterial antigen Ag85B leader peptide and transcription of the fusion protein is driven by an Ag85B promoter sequence. The recombinant fusion protein is produced in abundance by the rMyc, is post-translationally methylated, and is highly antigenic.

Abstract: Non-naturally occurring factor H binding proteins derived from variant 3 fHbp that can elicit antibodies that are bactericidal for at least one strain of N. meningitidis, and methods of use of such proteins, are provided. In certain embodiments, a non-naturally occurring factor H binding protein (fHbp) derived from a naturally occurring variant 3 fHbp is disclosed. The non-naturally fHbp may include a substitution of the histidine at position 223 of the naturally occurring variant 3 fHbp with an amino acid selected from the group consisting of arginine, lysine, phenylalanine, tyrosine, or tryptophan, wherein the numbering of position 223 is based on the numbering of the mature fHbp ID 1. The non-naturally occurring fHbp may have a lower affinity for human factor H (fH) than fHbp ID 79.

Abstract: This disclosure generally relates to antibodies or fragments thereof which interact with the bacterial protein MprF. The disclosure further discloses antibodies, which bind to specific extracellular motifs of MprF. The disclosure further relates to therapeutics comprising MprF-specific antibodies and methods of treatment using MprF-specific antibodies or fragments thereof.

Abstract: The invention provides a chaperone/usher family polymer comprising at least one chaperone/usher family polypeptide monomer, wherein said at least one chaperone/usher family polypeptide monomer comprises an exogenous bioactive sequence.

Abstract: The present invention relates to methods and compositions for the stimulation of immune responses. Specifically, the present invention provides methods of inducing an immune response to human immunodeficiency virus (HIV) in a subject (e.g., a human subject) and compositions useful in such methods (e.g., a nanoemulsion comprising HIV or antigenic portion thereof).

Abstract: Factor H binding proteins that can elicit antibodies that are bactericidal for at least one strain of N. meningitidis, and methods of use of such proteins, are provided.

Abstract: In one aspect, the invention relates to a composition including a first polypeptide having the sequence set forth in SEQ ID NO: 1 and a second polypeptide having the sequence set forth in SEQ ID NO: 2. In one embodiment, the composition includes about 120 ?g/ml of a first polypeptide including the amino acid sequence set forth in SEQ ID NO: 1, 120 ?g/ml of a second polypeptide including the amino acid sequence set forth in SEQ ID NO: 2, about 2.8 molar ratio polysorbate-80 to the first polypeptide, about 2.8 molar ratio polysorbate-80 to the second polypeptide, about 0.5 mg/ml aluminum, about 10 mM histidine, and about 150 mM sodium chloride. In one embodiment, a dose of the composition is about 0.5 ml in total volume. In one embodiment, two-doses of the composition induce a bactericidal titer against diverse heterologous subfamily A and subfamily B strains in a human.

Abstract: The present invention relates to methods for the rapid detection of the presence or absence of Staphylococcus aureus in a biological or nonbiological sample. The present invention includes methods of detection comprising performing an amplifying step, a hybridizing step, and a detecting step. Furthermore, the present invention relates to primers, probes, and kits that are designed for the detection of Staphylococcus aureus.

Abstract: The present invention relates to methods for the rapid detection of the presence or absence of Staphylococcus aureus in a biological or nonbiological sample. The present invention includes methods of detection comprising performing an amplifying step, a hybridizing step, and a detecting step. Furthermore, the present invention relates to primers, probes, and kits that are designed for the detection of Staphylococcus aureus.

Abstract: The present invention relates to methods for the rapid detection of the presence or absence of Staphylococcus aureus in a biological or nonbiological sample. The present invention includes methods of detection comprising performing an amplifying step, a hybridizing step, and a detecting step. Furthermore, the present invention relates to primers, probes, and kits that are designed for the detection of Staphylococcus aureus.

Abstract: In one aspect, the invention relates to an immunogenic composition that includes a mutant Clostridium difficile toxin A and/or a mutant Clostridium difficile toxin B. Each mutant toxin includes a glucosyltransferase domain having at least one mutation and a cysteine protease domain having at least one mutation, relative to the corresponding wild-type C. difficile toxin. The mutant toxins may further include at least one amino acid that is chemically crosslinked. In another aspect, the invention relates to antibodies or binding fragments thereof that binds to said immunogenic compositions. In further aspects, the invention relates to isolated nucleotide sequences that encode any of the foregoing, and methods of use of any of the foregoing compositions.

Abstract: Compounds of general formula (I): Ri—Wn—Xm-AAi-AA2-AA3-AA4-AA5-AA6-Yp—Zq—R2 (I) their stereoisomers, mixtures thereof and/or their cosmetically or pharmaceutically acceptable salts, preparation processes, cosmetic and/or pharmaceutical compositions which contain them and their use in medicine, particularly in the treatment and/or prevention of pain, inflammation, itching, pigmentation disorders and angiogenic skin disorders, and in processes of treatment and/or care of the skin and/or mucous membranes.

Abstract: The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine).

Abstract: The invention provides peptide compositions and mixtures useful for the detection of antibodies that bind to Ehrlichia antigens. The peptide compositions and mixtures comprise polypeptide sequences based on an immunogenic fragment of the Ehrlichia Outer Membrane Protein 1 (OMP-1) protein. The invention also provides devices, methods, and kits comprising such peptide compositions and mixtures useful for the detection of antibodies that bind to Ehrlichia antigens and the diagnosis of monocytic and/or granulocytic ehrlichiosis.

Abstract: Products and methods are disclosed for reducing the production of unwanted odors from the pudendum. The products include an acidifying composition comprising one or more carboxylic acids such as mandelic acid or salts thereof and xanthine compounds such as caffeine or salts thereof. The methods include application of the products to the pudendum in any of a variety of ways to effectively reduce unwanted odors.

Abstract: The present disclosure relates to surface proteins of Moraxella catarrhalis and their ability to interact with epithelial cells via cell-associated fibronectin and laminin, and also to their ability to inhibit the complement system. These surface proteins are useful in the preparation of vaccines. The present disclosure also provides peptides interacting with fibronectin, laminin and the complement system.

Abstract: A vaccine for protection against multiple serotypes of Shigella sp., comprising a putative heat shock protein (EL PGI II), and Hypothetical Protein (EL PGIV) is provided.

Abstract: The invention relates to a modified V2 fHbp having increased stability over a wild type V2 fHbp; a modified V2 fHbp having an amino acid sequence with at least 85% identity to the sequence of Seq ID No: 1, wherein both Ser137 and Gly138 are mutated or both Val112 and Leu114 are mutated; immunogenic, pharmaceutical and vaccine compositions; nucleic acid and a host cell; and methods of use of such compositions.

Abstract: Rapid methods that identify sepsis-causing bacteria or yeast aid the physician in critical therapeutic decision-making, thus decreasing patient mortality rates. The methods described herein employ plating microorganisms directly on to a MALDI-MS plate, adding concentrated formic acid, and identifying the microorganism by mass spectrometry. Optionally, an organic solvent may be combined with the formic acid, or added to the sample before or after the concentrated formic acid is added thereto. The methods enable direct extraction of proteins from microorganisms without the need for liquid protein extraction methods and yields positive identification results for gram-positive bacteria, gram-negative bacteria and yeast in minutes.

Abstract: The invention is directed to ?-defensin-derived peptides and their use in modulating the activity of hematopoietic cells, particularly hematopoietic stem cells and progenitor cells. Specifically, the invention provides compositions and methods useful for promoting mobilization and transplantation of hematopoietic stem cells and progenitor cells. The invention further provides compositions and methods useful in the treatment of cancer.

Abstract: The instant invention provides an immunogenic composition comprising an antigenic fragment of OspA protein of Borrelia burgdorferi and a chimeric protein containing antigenic fragments of different phylotypes of OspC protein of Borrelia burgdorferi. Vaccines incorporating the immunogenic composition of the invention, as well as methods of preventing Lyme disease in dogs and/or protecting dogs from Lyme disease using the vaccines are also provided.

Abstract: The present invention relates to immunogenic compositions comprising one or more Streptococcus pneumoniae capsular saccharide conjugates and a protein component comprising Protein E and/or PilA from Haemophilus influenzae.

Abstract: In one aspect, the invention relates to an isolated polypeptide comprising an amino acid sequence that is at least 95% identical to SEQ ID NO: 71. In another aspect, the invention relates to an immunogenic composition including an isolated non-lipidated, non-pyruvylated ORF2086 polypeptide from Neisseria meningitidis serogroup B, and at least one conjugated capsular saccharide from a meningococcal serogroup.

Abstract: The invention relates to the field of vaccines against microbial infections and especially bacterial vaccines, in particular to pneumococcal vaccines. More in particular, the invention relates to means and methods to identify, select and isolate a vaccine component for passive and/or active immunization against a microorganism that can be killed by opsonophagocytic cells. The invention relates to a method to identify an opsonophagocytosis inducing antigen as a vaccine component for immunization against a microorganism. The invention describes three pneumococcal proteins SlrA, IgA1 proteinase, and PsaA, and their use as a vaccine component with or without PpmA. The invention also discloses the use of antibodies against said proteins for passive immunization and diagnosis.

Abstract: Antigenic polypeptides comprising linear immunodominant epitopes of Borrelia outer surface protein A (OspA) or Borrelia outer surface protein C (OspC) are useful as vaccines against Lyme disease, and as diagnostics for detecting Borrelia infections. The OspA and OspC antigenic polypeptides typically comprise a plurality of peptides representing epitope containing regions from multiple distinct phyletic groups. The antigenic polypeptides may also include epitopes from both Borrelia OspA and Borrelia OspC.

Abstract: This invention describes novel adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37° C. that can be produced at remarkably low costs. This invention describes novel vaccine compositions and formulations to treat and prevent urinary tract infections caused by gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli. This invention also describes methods of administration of said novel vaccine compositions and formulations and methods of treatment to prevent and treat urinary tract infections caused by gram-negative bacteria including E. coli and multi-drug resistant E. coli.

Abstract: The invention provides an endoglycosidase, referred to as EndoS49 and having the amino acid sequence of SEQ ID NO: 1. EndoS49 was isolated from Streptococcus pyogenes strain NZ131 and is a homolog of EndoS. EndoS49 has specific endoglycosidase activity on native IgG and cleaves a larger variety of Fc glycans than EndoS. A mutant thereof where the glutamic acid at position 186 of SEQ ID NO: 1 was substituted was produced: said mutant lacks endoglycosidase activity but is capable of binding to IgG. Methods using EndoS49, deletions thereof and said mutant, especially for assessing glycosylation of IgG or for isolating IgG are disclosed.

Abstract: Broad-based, cross-protective, O-serotype independent vaccines against Shigella and related pathogenic organisms are provided. The vaccines comprise one or more of the type III secretion (TTS) apparatus needle proteins IpaD and IpaB, and/or the IpaB cognate chaperone protein IpgC. Chimeric proteins of IpaD and IpaB, and/or IpgC are also encompassed.

Abstract: This invention describes novel adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37° C. that can be produced at remarkably low costs. This invention describes novel vaccine compositions and formulations to treat and prevent urinary tract infections caused by gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli. This invention also describes methods of administration of said novel vaccine compositions and formulations and methods of treatment to prevent and treat urinary tract infections caused by gram-negative bacteria including E. coli and multi-drug resistant E. coli.

Abstract: The present invention relates to a peptide capable of forming a covalent complex consisting either of the Jo peptide, a derivative or a fragment thereof, or of the In peptide, a derivative or a fragment thereof. The present invention relates to the various uses thereof.

Abstract: The present invention provides for recombinant Endo-S mutants that exhibit reduced hydrolysis activity and increased transglycosylation activity for the synthesis of glycoproteins wherein a desired sialylated oxazoline or synthetic oligosaccharide oxazoline is added to a core fucosylated or nonfucosylated GlcNAc-protein acceptor. Such recombinant Endo-S mutants are useful for efficient glycosylation remodeling of IgG1-Fc domain to provide different antibody glycoforms carrying structurally well-defined Fc N-glycans.

Abstract: The present invention relates to pathogen detection and identification by use of DNA resequencing microarrays. The present invention also provides resequencing microarray chips for differential diagnosis and serotyping of pathogens present in a biological sample. The present invention further provides methods of detecting the presence and identity of pathogens present in a biological sample.

Abstract: The present invention relates to generation and high level expression of recombinant non-toxic of epsilon toxin of Clostridium perfringens as a recombinant vaccine against Clostridium perfringens infection and a process for producing the vaccine involving amplifying, cloning, transforming, incubating and purifying the recombinant non-toxic epsilon toxin protein. Thus in this invention, substitution mutation Y71G was executed in recombinant Etx and the recombinant EtxY71G protein was over-expressed in soluble form. Expressed protein was purified near homogeneity by DEAE sepharose anion exchange chromatography with high yield. Potential of rEtxY71G as a vaccine candidate was evaluated and found to be highly specific and immunogenic. The present invention is the first report for high level expression of non toxic rEtxY71G mutant protein of Clostridium perfringens. Upto 100 mg/L of highly immunogenic and homogeneous recombinant EtxY71G protein of 31 kDa was produced.

Abstract: The present invention provides compositions comprising a Chlamydial major outer membrane protein (referenced herein as “MOMP”), from at least one Chlamydial serovar and an adjuvant, characterized in that the adjuvant comprises the product E6020 having CAS Number 287180-63-6. The composition may further comprise at least one carrier system (e.g., emulsion, mineral particle). The MOMP protein may be derived from any species of Chlamydia (e.g., C. trachomatis, C. pneumoniae, C. psittaci, or C. trachomatis MoPn). In preferred embodiments, the composition comprises one or more major outer membrane proteins each derived from different serovars of C. trachomatis. The invention also provides methods of inducing an immune response to a Chlamydia species (e.g., C. trachomatis) in a subject, by administering to the subject a composition of the invention.

Abstract: Compositions and methods for preventing and treating pneumococcal infections are provided. Compositions include novel polypeptides comprising an amino acid sequence corresponding to the R21 or R22 domain of CbpA or a consensus sequence of one of these domains, and variants and fragments thereof, wherein the polypeptide is stabilized in a desired conformation, particularly a loop conformation. The polypeptides of the invention may be engineered to comprise a first and a second cysteine residue, thereby resulting in the formation of a disulfide bond that stabilizes the polypeptide in the desired conformation. Alternatively, a polypeptide of the invention may be modified to create a synthetic linkage between a first and second amino acid residue present within the polypeptide, wherein the synthetic linkage stabilizes the polypeptide in the desired conformation. The polypeptides of the invention may further comprise an amino acid sequence for a T cell epitope.

Abstract: Described are compositions and methods for detecting or monitoring the ability of an individual to mount a cell mediated immune response to a target antigen. Methods rely in part upon the physical association, e.g., by fusion, of a Lethal Factor (LF) polypeptide with a target antigen. The LF polypeptide moiety, including, for example, an LFn polypeptide moiety, serves as a transport factor to deliver target antigens, including full length target polypeptides, to the cytosol of an intact, living immune cell from an individual. Measurement of a cytokine response by the immune cell from the individual provides a read out of a cell mediated immune response. The methods and compositions described provide diagnostic as well as prognostic information and can guide the direction of therapy.

Abstract: The present invention provides vectors that contain and express in vivo or in vitro sand fly Lu. longipalpis salivary antigens that elicit an immune response in animal or human against Leishmania, vaccine compositions comprising said vectors and/or Lu. longipalpis salivary polypeptides, methods of vaccination against Leishmania, and kits for use with such methods and compositions.

Abstract: Compositions and methods are provided for the prevention and treatment of bacterial infections, including pneumococal infections. Compositions provided herein comprise a variety of immunogenic fusion proteins, wherein at least one polypeptide component of a given fusion protein comprises a CbpA polypeptide and/or a cytolysoid polypeptide, or an active variant or fragment thereof. Methods are provided for the prevention and treatment of bacterial infections, including pneumococcal infections by employing the various immunogenic fusion proteins having at least one polypeptide component comprising a CbpA polypeptide and/or a cytolysoid polypeptide, or an active variant or fragment thereof.

Abstract: Disclosed are methods of identifying an individual having a predisposition to the development of a cardiovascular disease, and administering a suitable prophylactic agent to the identified individual to prevent disease. Methods of screening and identifying agents that inhibit bacterial collagen binding protein (CBP)-mediated cell invasion are also disclosed.

Abstract: Lectin compositions and methods for reducing tumor cell growth and preventing or treating cancer are provided.

Abstract: The use of flagellin and flagellin related polypeptides for the protection of mammals from the effects of apoptosis is described.

Abstract: Vaccination with the combination of Ag85B-TB10.4 and IC31® adjuvant generated a high amount of polyfunctional CD4+T cells expressing high levels of IFN-?, TNF-?, and IL-2. This in turn led to significant protection against infection with M. tuberculosis in the mouse aerosol challenge model of tuberculosis. Both the immunogenicity of the vaccine and its ability to protect against TB infection was highly dependent on the antigen dose. Thus, whereas the standard antigen dose of 5 ?g, as well as 15 ?g, did not induce significant protection against M. tuberculosis, reducing the dose to 0.5 ?g increased both the immunogenicity of the vaccine as well as its protective efficacy to a level comparable to that observed in BCG vaccinated mice. Thus, the IC31® adjuvant, with the specified antigen dose, can induce a strong protective Th1 response against M. tuberculosis.