Abstract: Immunogenic compositions comprising one or more inactivated dengue viruses and one or more inactivated non-dengue flaviviruses and methods of making and using thereof are provided.

Abstract: Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

Abstract: An assay method is described, which comprises the steps of immobilizing a binding partner (e.g., an antigen or antibody) for an analyte to be detected (e.g., an antibody or antigen) on a portion of a surface of a microfluidic chamber; passing a fluid sample over the surface and allowing the analyte to bind to the binding partner; allowing a metal colloid, e.g., a gold-conjugated antibody, to associate with the bound analyte; flowing a metal solution, e.g., a silver solution, over the surface such as to form an opaque metallic layer; and detecting the presence of said metallic layer, e.g., by visual inspection or by measuring light transmission through the layer, conductivity or resistance of the layer, or metal concentration in the metal solution after flowing the metal solution over the surface.

Abstract: The present invention relates to the construction of a new class of Targeted Secretion Inhibitors (TSIs), which comprise a non-cytotoxic protease, translocation peptide and a targeting moiety peptide, wherein the targeting moiety peptide has a free N-terminal domain and a free C-terminal domain; to a single-chain fusion protein precursor thereof, and to a method of activating said single-chain fusion protein precursor.

Abstract: Aqueous gel formulations, including an immune response modifier (IRM), such as those chosen from imidazoquinoline amines, tetrahydroimidazoquinoline amines, imidazopyridine amines, 6,7-fused cycloalkylimidazopyridine amines, 1,2-bridged imidazoquinoline amines, imidazonaphthyridine amines, imidazotetrahydronaphthyridine amines, oxazoloquinoline amines, thiazoloquinoline amines, oxazolopyridine amines, thiazolopyridine amines, oxazolonaphthyridine amines, thiazolonaphthyridine amines, pyrazolopyridine amines, pyrazoloquinoline amines, tetrahydropyrazoloquinoline amines, pyrazolonaphthyridine amines, tetrahydropyrazolonaphthyridine amines, and 1H-imidazo dimers fused to pyridine amines, quinoline amines, tetrahydroquinoline amines, naphthyridine amines, or tetrahydronaphthyridine amines, are provided. Methods of use and kits are also provided.

Abstract: The present invention discloses methods and materials for delivering a cargo compound into a brain cancer cell and/or across the blood-brain barrier. Delivery of the cargo compound is accomplished by the use of protein transport peptides derived from Neisseria outer membrane proteins, such as Laz. The invention also provides synthetic transit peptides comprised of the pentapeptide AAEAP. The invention further discloses methods for treating cancer, and specifically brain cancer, as well as other brain-related conditions. Further, the invention provides methods of imaging and diagnosing cancer, particular brain cancer.

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 a therapeutic compound comprising: an agent that inhibits the activity of at least one gene selected from the group consisting of MAF, MEOX2, SIX2 and homologs thereof having at least 50% identity with said genes and/or an agent that enhances the activity of at least one gene selected from the group consisting of CREB5, E2F1, EGR2, HIC1, IRF7, JUN, MYC, SRF, STAT4, TCF4, FOXS1, GLI1, SOX9 and homologs thereof having at least 50% identity with said gene for use in the treatment of wounds, preferably chronic wounds.

Abstract: This document provides methods and materials related to treating glaucoma, ocular hypertension, cardiovascular diseases, and renal diseases. For example, this document provides isolated nucleic acid molecules and viral vectors (e.g., lentiviral vectors) containing isolated nucleic acid molecules. Methods for reducing intraocular pressure as well as symptoms and progression of cardiovascular and renal diseases also are provided.

Abstract: Provided is an immunogenic composition comprising 15 different polysaccharide-protein conjugates. Each of the conjugates comprises a capsular polysaccharide prepared from different serotype Streptococcus pneumoniae conjugated to a carrier protein, that is, serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 9N, 9V, 14, 18C, 19A, 19F and 23F. An immunogenic composition formulated into a vaccine comprising an aluminum-based adjuvant increases application range with respect to pneumococcal diseases in infants and children.

Abstract: A liquid pharmaceutical composition having a conjugated erythropoietin, buffer, sugar, tonicity modifier and amino acid as an aggregation inhibitor. The liquid pharmaceutical composition provides a stable pharmaceutical composition which encompasses conjugated erythropoietin, acetate buffer, sucrose, arginine and sodium chloride which is maintained at a pH of about 4.9 to 5.3.

Abstract: The invention relates to amino sphingoglycolipid analogues and peptide derivatives thereof, compositions comprising these compounds and methods of treating or preventing diseases or conditions using such compounds, especially diseases or conditions relating to cancer, infection, atopic disorders, autoimmune disease or diabetes.

Abstract: The invention provides, inter alia, populations of large mesenchymal stem cells (MSC)(as well as conditioned medium from these cells) with enhanced regenerative potential, as well as methods of culturing and using these populations, such as therapeutic methods of mediating tissue repair or enhancing homing and engraftment of hematopoietic stem cells. These large MSC populations can, in certain embodiments, be produced by biophysically sorting an MSC-containing population.

Abstract: The present disclosure is related to immunomodulatory bacterial minicells and methods of using the minicells.

Abstract: Provided is an immunogenic composition comprising 15 different polysaccharide-protein conjugates. Each of the conjugates comprises a capsular polysaccharide prepared from different serotype Streptococcus pneumoniae conjugated to a carrier protein, that is, serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 9N, 9V, 14, 18C, 19A, 19F and 23F. An immunogenic composition formulated into a vaccine comprising an aluminum-based adjuvant increases application range with respect to pneumococcal diseases in infants and children.

Abstract: The present application relates to highly concentrated antibody and protein formulations with reduced viscosity that are stable, relatively isotonic and are of low turbidity. The formulations are particularly suitable for subcutaneous administration. The application further describes articles of manufacture containing such formulations and method for using them to treat disorders treatable by the formulated antibody or protein.

Abstract: Disclosed are novel immunogenic proteins derived from Staphylococcus aureus, as well as methods for their use in conferring protective immunity against S. aureus infections. Also disclosed are nucleic acids encoding the proteins and methods of use of these nucleic acids.

Abstract: The invention relates to a method to encapsulate nanoparticles into a protein cage by inserting the nanoparticles into the core through holes. Currently commercially available nanoparticles can be functionalized using the inventive method. The inventive hybrids have applications in biosensing and bioimaging. The use of an affinity between poly-histidine chains and nitrilotriacetic acid as chelating reagent to obtain the inventive cages and hybrid assemblies by the method according to the invention is shown in FIG. 1.

Abstract: Methods of detecting influenza, including differentiating between type and subtype are disclosed, for example to detect, type, and/or subtype an influenza infection. A sample suspected of containing a nucleic acid of an influenza virus, is screened for the presence or absence of that nucleic acid. The presence of the influenza virus nucleic acid indicates the presence of influenza virus. Determining whether the influenza virus nucleic acid is present in the sample can be accomplished by detecting hybridization between an influenza specific probe, influenza type specific probe, and/or subtype specific probe and an influenza nucleic acid. Probes and primers for the detection, typing and/or subtyping of influenza virus are also disclosed. Kits and arrays that contain the disclosed probes and/or primers also are disclosed.

Abstract: The invention relates to a method for determining the presence of at least one distinct polypeptide in a biological sample comprising contacting the biological sample with a hydrolyzing agent, wherein the hydrolyzing agent is capable of hydrolyzing the distinct polypeptide in a sequence-specific manner such that at least one distinct peptide having a predetermined peptide measured accurate mass would result if the at least one distinct polypeptide were present in the biological sample, to obtain a hydrolyzed sample; bringing the hydrolyzed sample in contact with a substrate comprising at least one immobilized binding partner, wherein the at least one immobilized binding partner is capable of specifically binding the distinct peptide; removing the hydrolyzed sample from the substrate in a manner such that the distinct peptide would remain bound to the immobilized binding partner; contacting the substrate with an elution solution, wherein the distinct peptide would dissociate from the immobilized binding partne

Abstract: Methods for enhancing or stimulating hematopoiesis including the step of administering Interleukin-12 (IL-12) to yield hematopoietic recovery in a mammal in need. Preferred methods include the step of administering IL-12 as an adjuvant therapy to alleviate the hematopoietic toxicities associated with one or more treatment regimens used to combat a disease state. Other methods include administering IL-12 to ameliorate various hematopoietic deficiencies. Still other methods are directed to uses of IL-12 for in-vivo proliferation of hematopoietic repopulating cells, hematopoietic progenitor cells and hematopoietic stem cells. Other disclosed methods are directed to uses of Il-12 for bone marrow preservation or recovery.

Abstract: An objective of the present invention is to provide stable antibody-containing formulations which are suitable for subcutaneous administration and in which aggregation formation is suppressed during long-term storage. The present inventors discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid as a counter ion species in histidine buffer or tris(hydroxymethyl)aminomethane, specifically by using histidine-aspartate buffer or histidine-glutamate buffer, or tris(hydroxymethyl)aminomethane-aspartate or tris(hydroxymethyl)aminomethane-glutamate as a buffer. The present inventors also discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid, as a counter ion species to a basic amino acid such as arginine, specifically by using arginine-aspartate or arginine-glutamate.

Abstract: Disclosed are compositions and methods for treatment of breast cancer. Disclosed methods and compositions include dendritic cells loaded with cyclin B1 and WT-1 peptide antigens for immunotherapy. These dendritic cell vaccines are administered alone or in combination with other cancer therapies to improve outcomes. Disclosed methods also involve the use of therapeutic agents, such as anakinra, that block the IL-1 inflammation pathway. These agents are used in combination with chemotherapy and/or immunotherapy in treating breast cancer.

Abstract: The present invention relates to a method for generating immunoglobulin sequences against cell-associated antigens, more particularly, antigens that are membrane-anchored. The invention also provides immunoglobulin sequences obtainable by the method of the invention. Specifically, the present invention relates to the generation of immunoglobulin sequences by use of DNA vaccination. More specifically, the present invention relates to generation of immunoglobulin sequences in camelids, preferably directed against cell-associated antigens, in particular antigens with multiple transmembrane spanning domains, including GPCRs and ion channels, by DNA vaccination. Furthermore, the present invention relates to said immunoglobulin sequences against cell-associated antigens, more particularly, antigens that are membrane-anchored, such as e.g. GPCRs and ion channels, more preferably ion channels.

Abstract: Embodiments of the invention comprise an improved vaccine for generating an immune response and preventing or treating mycobacterial diseases such as tuberculosis in humans and animals. Embodiments of the invention also comprise a method for using the vaccine against such mycobacterial diseases.

Abstract: The invention relates to a novel use of a Bordetella adenylcyclase toxin in the manufacturing of vectors for targeting in vivo a molecule of interest, specifically to CD11b expressing cells. The invention also relates to an immunogenic composition that primes immune responses, to pharmaceutical compositions and to a new vector for molecule delivery to CD11b expressing cells.

Abstract: The present invention provides an immune response modifier (IRM) composition that includes an IRM moiety and a second active moiety covalently linked to the IRM moiety, wherein the covalent link comprises a labile bond directly attached to the IRM moiety.

Abstract: The invention relates to composite antigens comprising a peptide with contiguous amino acid sequence derived from a plurality of antigenic epitopes of one or more pathogens that induces an immune response in a mammal that is protective against infection by the one or more pathogens. In addition, the invention relates to vaccines comprising composite antigens and to method for treating and preventing an infection.

Abstract: A method of diagnosing tuberculosis (TB) disease and distinguishing between active TB and latent TB infection in a subject is described herein. A sample from the subject is stimulated with at least one Mycobacterium tuberculosis (M.tb) infection phase-dependent antigen selected from Rv0081, Rv2032, Rv1737c, Rv2389c, Rv0867c, TB18.2, Rv2099c, Rv1733c, M.tb PPD, PHA and ESAT-6/CFP-10 and the presence of at least one host marker in the sample is detected, the host marker being selected from EGF, TGF-?, TNF-?, VEGF, RANTES, IL-12(p40), IL-12(p70), IL-10, IP-10, IFN-?2, fractalkine, IFN-?, IL-13, IL-1Ra, IL-3, IL-4, IL-5, MIP-1?, ENA-78, BCA-1, TARC, X6-Ckine, eotaxin, eotaxin-2, SCF, APOA-1, APOE, HPALBN, HCF, Serum amyloid protein A (SAA), C-reactive protein (CRP), serum amyloid protein P (SAP), TIMP-1, MIP-1?, IL-6, GM-CSF, IL-1?, MMP-9, MMP-2, MCP-1, TRAIL, IL-15, IL-17F, IL-22, TNF-?, MCP-2 and MCP-4. Additional host markers may also be detected in an unstimulated sample from the subject.

Abstract: Provided herein are compositions and methods for the treatment or prevention of pathogenic infections.

Abstract: The present invention includes a method of introducing a pathogenic infection into one or more peripheral lymph nodes of an animal for testing of meat, comprising: inoculating at one or more peripheral lymph node drainage areas the animal with a known amount of a known pathogen; harvesting one or more peripheral lymph nodes from the animal; grinding meat or meat trimmings and the one or more peripheral lymph nodes into ground meat; and determining a ratio of a number of peripheral lymph nodes infected to the weight of the meat or meat trimmings used to create the ground meat, wherein the infected ground meat can be used to test interventions against the known pathogen in a grinding process.

Abstract: The present invention pertains inter alia to a method for analyzing a sample comprising biomolecules, which comprises the following steps: A a) lysing the sample to provide a lysed sample and optionally clearing the lysed sample; b) contacting at least a portion of the lysed sample with a dry composition comprising reagents for performing the analytical method, thereby providing a reconstituted composition; c) performing an analytical method using the reconstituted composition; or B a) contacting the sample with a lysis solution thereby providing a lysis mixture; b) using the lysis mixture to reconstitute a dry composition comprising reagents for performing the analytical method, thereby providing a reconstituted composition; c) performing an analytical method using the reconstituted composition, wherein the reconstituted composition is optionally cleared and wherein subsequent to step b) at least one step is performed which supports the lysis of the sample.

Abstract: Disclosed are methods for isolating, cultivating, and/or cells including regulatory T cells (Tregs). The methods typically include cultivating cells including Tregs in a culture media comprising a ligand for programmed cell death receptor (PD-1) conjugated to a solid support. Suitable ligands may include PD-L1 and suitable solid supports may include magnetic or paramagnetic beads where the methods further include removing the PD-L1/bead conjugates after the Tregs have been isolated, cultured, and/or expanded.

Abstract: The present invention relates to vaccines comprising a ShK domain of a filarial nematode protein. These vaccines may be used for the prevention and/or treatment of filarial nematode infections. The invention also relates to novel proteins comprising a ShK domain of a filarial nematode protein and pharmaceutical compositions. The invention may be used for the prevention and/or treatment of filarial nematode infections in canine subjects, and also in human subjects.

Abstract: The invention described herein relates to a Haemophilus influenzae (H. influenzae) regulon encoding type IV pili. In particular, the invention relates to type IV pili from nontypeable H. influenzae (NTHi) and from H. influenzae strains a, b, c, e and f. The invention provides isolated H. influenzae pilus polynucleotides and polypeptides encoded by the polynucleotides as well as polynucleotides and polypeptides encoded by the polynucleotides involved in the assembly/disassembly of the structure. The invention also relates to uses of these polynucleotides and/or polypeptides including methods for eliciting an immune response to H. influenzae and methods of treating and preventing H. influenzae related pathological conditions.

Abstract: The invention provides compositions comprising bacterial strains for treating and preventing inflammatory and autoimmune diseases.

Abstract: Disclosed are immunotherapeutic compositions and methods for preventing and/or treating hepatitis delta virus (HDV) infection, including yeast-based HDV immunotherapeutic compositions and methods of use of such compositions to prevent and/or treat HDV infection and symptoms and sequela thereof.

Abstract: The present invention provides methods and compositions to confer and/or augment immune responses mediated by cellular immunotherapy, such as by adoptively transferring genetically modified tumor specific CD8+ T cells in the presence of tumor-specific, subset specific genetically modified CD4+ T cells, wherein the CD4+ T cells confer and/or augment a CD8+ T cells ability to sustain anti-tumor reactivity and increase and/or maximize tumor-specific proliferation of the tumor-specific CD8+ T cells of interest. Pharmaceutical formulations produced by the method, and methods of using the same, are also described.

Abstract: There is provided an antigenic composition comprising (a) a first mycobacterial antigenic polypeptide or a first mycobacterial polynucleotide; and (b) a second mycobacterial antigenic polypeptide or a second mycobacterial polynucleotide; wherein: (i) said first mycobacterial antigenic polypeptide comprises a polypeptide sequence having at least 70% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 1 or 7, or a fragment thereof having at least 7 consecutive amino acids thereof; (ii) said first mycobacterial polynucleotide comprises a polynucleotide sequence encoding said first mycobacterial antigenic polypeptide; (iii) said second mycobacterial antigenic polypeptide comprises a polypeptide sequence having at least 70% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 5, or a fragment thereof having at least 7 consecutive amino acids thereof; and (iv) said second mycobacterial polynucleotide comprises a polynucleotide sequence encoding said second mycobacterial polypeptid

Abstract: An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated to a carrier protein. The immunogenic composition, formulated as a vaccine, increases coverage against pneumococcal disease in infants and young children globally, and provides coverage for serotypes 6A and 19A that is not dependent on the limitations of serogroup cross-protection.

Abstract: The present invention provides methods and compositions for the stimulation of immune responses. In particular, the present invention provides nanoemulsion compositions and methods of using the same for the induction of immune responses (e.g., innate and adaptive immune responses (e.g., for generation of host immunity against an environmental pathogen)). Compositions and methods of the present invention find use in, among other things, clinical (e.g. therapeutic and preventative medicine (e.g., vaccination)) and research applications.

Abstract: Provided are tri-component matrices having collagen, hyaluronan, and chondroitin sulfate. Also provided are processes for producing a tri-component matrix. Additionally, provided are processes for providing cells capable of producing cartilage to a bone or cartilage defects.

Abstract: The present invention relates to compositions and methods for the prevention and treatment of Borrelia infection. Particularly, the present invention relates to a polypeptide comprising a hybrid C-terminal fragment of an outer surface protein A (OspA), a nucleic acid coding the same, an antibody specifically binding the same, a pharmaceutical composition (particularly for use as a medicament or in a method of treating or preventing a Borrelia infection) comprising the polypeptide and/or the nucleic acid and/or the antibody, a method of treating or preventing a Borrelia infection and a method of immunizing a subject.

Abstract: The present invention aims at providing an injectable vaccine composition that is safe, useful as a prophylactic or therapeutic agent for cancers or infectious diseases, and capable of inducing the systemic immune response safely and effectively.

Abstract: The present invention relates to novel peptide compounds derived from flagellin originating from Salmonelle enterica that exhibit an in vivo immune adjuvant activity.

Abstract: Disclosed is a device and method for treating a neurodegenerative disease or condition associated with neuroinflammation induced by a leukotriene. The device is a film unit dosage form having a film layer and a safe and effective amount of a leukotriene receptor antagonist or leukotriene synthesis inhibitor. The device is configured and formulated to achieve transmucosal and/or enteral delivery of the leukotriene receptor antagonist or leukotriene synthesis inhibitor. The method includes transmucosally and/or enterally delivering to an animal in need of treatment, a safe and effective amount of a leukotriene blocker capable of crossing the blood-brain barrier.

Abstract: A kit having instructions for use for performing uterine lavage in a female patient includes a uterine lavage catheter configured for insertion into a woman's uterus to remove viable blastocysts from the uterus, and one or more first containers having a sufficient dosage amount of a GnRH antagonist to cause desynchronization of the endometrium of the patient prior to, during and/or following recovery of viable blastocysts from the uterus.

Abstract: Peptides and peptide analogs that selectively inhibit angiotensin II are described. Additionally, a method for making and using the peptides and peptide analogs are also described.

Abstract: Provided are oligonucleotides that are capable of detecting KRAS and PIK3CA mutations in both cancer patients and healthy individuals with high specificity in kPCR assays. When the oligonucleotides are used as forward primers in conjunction with a defined genotyping algorithm spreadsheet, the primers are capable of enhancing detection of KRAS codon 12, 13, and 61 and PIK3CA codon 542, 545, and 1047 single nucleotide polymorphisms (SNPs) in a background of wild-type sequences. The oligonucleotides of the present invention are also capable of preventing pseudogene amplification when the oligonucleotides are hybridized as reverse primers or detection probes to the mismatch sequences.

Abstract: The present invention concerns: a) an isolated peptide comprising an amino acid sequence which is at least 90% identical to the VP4 amino acid sequence of a rhinovirus, or an isolated polynucleotide comprising a nucleic acid sequence encoding said peptide, placed under the control of the elements necessary for its expression in a mammalian cell; and/or b) an isolated peptide comprising an amino acid sequence of at least 100 amino acids which is at least 90% identical to an amino acid sequence located in the last 363 C-terminal amino acids of the RNA polymerase of a rhinovirus, or an isolated polynucleotide comprising a nucleic acid sequence encoding said peptide, placed under the control of the elements necessary for its expression in a mammalian cell; and c) a Th1 adjuvant when said immunogenic composition comprises one or more of said isolated peptides.