Abstract: The present invention relates to a composition comprising at least one mimotope of an epitope of alpha-synuclein for use in a method for preventing and/or treating ?-amyloidoses including Alzheimer's disease, wherein said at least one mimotope is coupled or fused to a pharmaceutically acceptable carrier protein selected from the group consisting of a non-toxic diphtheria toxin mutant, keyhole limpet hemocyanin (KLH), diphtheria toxin (DT), tetanus toxid (TT) and Haemophilus influenzae protein D (protein D).

Abstract: The present invention relates to the use of a therapeutically effective amount of abscisic acid (ABA) or its analogs to treat or prevent inflammation induced by exposure to lipopolysaccharide (LPS) or respiratory inflammation. The invention also relates to methods and composition for enhancing vaccine efficacy using ABA.

Abstract: This invention provides a method of treating a subject afflicted with active lupus arthritis comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the subject. This invention also provides laquinimod or pharmaceutically acceptable salt thereof for use in treating a subject afflicted with active lupus arthritis. This invention further provides a pharmaceutical composition comprising an amount of laquinimod or pharmaceutically acceptable salt thereof for use in treating a subject afflicted with lupus arthritis.

Abstract: Embodiments of the present invention relate to compositions and methods of treating type 1 or type 2 diabetes mellitus or other conditions relating to metabolic dysfunction that may impact insulin secretion or action by administering an islet neogenesis agent in combination with an agent or agents that selectively inhibits, blocks or destroys the autoimmune destruction of pancreatic cells or agents that optimize function within existing islets in patients with type 1 diabetes, type 2 diabetes and related conditions.

Abstract: Shigella vaccine strains whose primary attenuating feature is deletion of the virG(icsA) gene and additional two or more deletions in setAB(shET1), senA(shET2), senB(shET2-2), stxAB, and msbB2 genes. Thus, the vaccine strain will have three or more deletions in the identified genes, will be safer, and will reduce or eliminate symptoms of fever and diarrhea in humans. The following specific vaccine strains have been constructed: WRSS3 (?senA, ?senB, ?virG, ?msbB2), WRSf2G15 (?virG, ?setAB, ?senA, ?senB, ?msbB2), and WRSd5 (?virG, ?stxAB, ?senA, ?senB, ?msbB2).

Abstract: This invention concerns a liposome comprising lipids and at least one active ingredient, wherein at least one of the lipids is a cationic lipid; said liposome exhibiting a net positive charge at physiological conditions at which said liposome preferentially adheres to monocytes in freshly drawn blood when compared to adherence to granulocytes, T-lymphocytes, B-lymphocytes and/or NK cells in freshly drawn blood, to a lipid-based pharmaceutical composition comprising said liposomes and their use in monocytic associated prophylaxis, treatment or amelioration of a condition such as cancer, an infectious disease, an inflammatory disease, an autoimmune disease or allergy.

Abstract: Emulsion vaccine formulations containing an antigen and an adjuvant in the aqueous phase are used for the vaccination of animals wherein the adjuvant is an acrylic polymer and/or dimethyl dioctadecyl ammonium bromide (DDA). These formulations can be prepared by mixing an aqueous phase containing the antigen and adjuvant with an oil phase in the presence of an emulsifier.

Abstract: The purpose of the present invention is to provide a better intestine immunomodulator. The intestine immunomodulator of the present invention comprises bacterial cells or a bacterial component of a Lactobacillus paracasei K71 strain having an international deposit No.: FERM BP-11098 as an active ingredient. Preferably, the intestine immunomodulator is used to facilitate production of secretory immunoglobulin A or to activate natural killer cells.

Abstract: The present invention describes vaccines that comprise C. perfringens Type alpha toxoids, antigenic fragments thereof, inactivated antigenic fragments of C. perfringens Type alpha toxins, or any combination thereof. The present invention further describes methods of using with these vaccines to protect animals against clostridial diseases. The present invention also describes methods of making these vaccines.

Abstract: Immune-stimulatory compositions and methods of manufacture are described with an unexpectedly greater immunostimulatory effect on the immune system than the individual components alone. The compositions include a combination of arabinogalactan protein (AGP) compounds, particularly those derived from honey or with similar activity to honey derived AGP's along with apisimin proteins, peptides or functional fragments thereof, particularly those isolated from royal jelly or apisimin produced via recombinant methods.

Abstract: An adjuvant for transdermal or transmucosal administration which comprises at least one substance selected from an aliphatic alcohol, a free fatty acid and a fatty acid derivative but does not contain a substance represented by the following formula: wherein R3 and R4 may together form a cyclic ring, and R1 and R2 independently represent an alkyl side chain having 1 to 16 carbon atoms.

Abstract: Glycosphingolipids (GSLs) bearing ?-glucose (?-Glc) that preferentially stimulate human invariant NKT (iNKT) cells are provided. GSLs with ?-glucose (?-Glc) that exhibit stronger induction in humans (but weaker in mice) of cytokines and chemokines and expansion and/or activation of immune cells than those with ?-galactose (?-Gal) are disclosed. GSLs bearing ?-glucose (?-Glc) and derivatives of ?-Glc with F at the 4 and/or 6 positions are provided. Methods for iNKT-independent induction of chemokines by the GSL with ?-Glc and derivatives thereof are disclosed. Methods for immune stimulation in humans using GSLs with ?-Glc and derivatives thereof are provided.

Abstract: The present disclosure relates to nutritional compositions for pediatric subjects, such as children's nutritional products and infant formulas, comprising a protein source, a fat source, and a source of ?-1,3-glucan.

Abstract: The present invention is directed to methods of suppressing an immune response in a subject in need thereof comprising administering a therapeutically effective amount of a compound having the following formula: to the subject in need thereof, wherein R1-5 represents from one to five substituents independently selected from hydrogen, nitro, cyano, C1-C3-alkyl, halogen, carboxy, amino, trifluoromethyl, hydroxy, C1-C3-alkoxy groups, X is hydrogen, halo, N3, SH, ?O, ?CH2, an aromatic, preferably phenyl, ring optionally substituted by R1-5 groups as defined above, amino, mono- or disubstituted amino groups wherein the substituents are selected from C1-C4 alkyl, phenyl or benzyl groups optionally substituted by R1-5 groups as defined above Y is hydrogen, allyl C1-C4, amino, or a group of formula —(CH2)0-1A wherein A is an aromatic, preferably phenyl, ring optionally substituted by R1-5 groups as defined above with the proviso that when X and Y are hydrogen, R1-5 cannot represent a 4-hydroxy or 4-alkoxy groups

Abstract: Disclosed are methods of enhancing cell-mediated immunity in an individual using nutritional compositions including human milk oligosaccharides. The human milk oligosaccharides are sialylated human milk oligosaccharides, fucosylated human milk oligosaccharides, or a combination of both. The human milk oligosaccharides may enhance T-cell mediated responses and T-cell regulatory responses.

Abstract: The current invention pertains to an aqueous composition containing a biological antigen and an acrylic acid polymer, wherein the composition comprises an electrolyte to provide an osmolarity higher than the osmolarity of a 0.9% (w/v) sodium chloride solution in water. The invention also pertains to the acrylic acid polymer for use in a one shot vaccine against porcine circo virus 2 (PCV2) and optionally Mycoplasma hyopneumoniae and in an aqueous composition for reducing fever induced by the biological antigens present in the aqueous composition when the composition is administered to a subject animal.

Abstract: The present invention is directed to a polymeric carrier cargo complex, comprising as a cargo at least one nucleic acid (molecule) and disulfide-crosslinked cationic components as a (preferably non-toxic and non-immunogenic) polymeric carrier. The inventive polymeric carrier cargo complex allows for both efficient transfection of nucleic acids into cells in vivo and in vitro and/or for induction of an (innate and/or adaptive) immune response, preferably dependent on the nucleic acid to be transported as a cargo. The present invention also provides, pharmaceutical compositions, particularly vaccines and adjuvants, comprising the inventive polymeric carrier cargo complex and optionally an antigen, as well as the use of such the inventive polymeric carrier cargo complex and optionally an antigen for transfecting a cell, a tissue or an organism, for (gene-)therapeutic purposes as disclosed herein, and/or as an immunostimulating agent or adjuvant, e.g.

Abstract: Provided are compositions and methods for delivering biological moieties such as modified nucleic acids into cells to kill or reduce the growth of microorganisms. Such compositions and methods include the use of modified messenger RNAs, and are useful to treat or prevent microbial infection, or to improve a subject's heath or wellbeing.

Abstract: A mucosal vaccine for the prevention or treatment of microbial infections is described that is capable of inducing vaccine antigen-specific immune responses in an organism without the addition of a mucosal adjuvant. The mucosal vaccine comprises a composite of a nanogel comprising a hydrophilic polysaccharide having a cationic functional group and a hydrophobic cholesterol added thereto as a side chain and a vaccine antigen. The vaccine is administered via a mucosal route.

Abstract: The invention relates to therapy and methods of applying the therapy to cancer patients. The invention includes introducing intratumorally cytotoxic T lymphocyte and/or NKT cells, and prior to, coincident with, or following introducing intratumorally the cytotoxic T lymphocyte and/or NKT cells, introducing intratumorally anti-TNF and/or anti-IL-10 to the patient. The cytotoxic T lymphocyte and/or NKT cells can be induced by the intratumoral introduction of immature dendritic cells to the patient. This therapy of the invention can be effective to regress, reduce or eliminate tumor cells in tumor tissue of the patients in the absence of radiation therapy.

Abstract: A composition for diet supplementation to improve gut microflora is disclosed. The composition includes a prebiotic source and source of nucleotides, such as an extract of yeast. Also disclosed are methods of diet supplementation that include administering compositions of the invention to an individual.

Abstract: The present invention relates to a use of at least one glycosylated tetrafunctional amphiphilic block copolymer, as immune adjuvant.

Abstract: Provided are electrokinetically-altered fluids (gas-enriched electrokinetic fluids) comprising an ionic aqueous solution of charge-stabilized oxygen-containing nanostructures in an amount sufficient to provide modulation of at least one of cellular membrane potential and cellular membrane conductivity, and therapeutic compositions and methods for use in treating diabetes and diabetes-associated conditions or disorders (e.g., insulin resistance), or symptoms thereof. Provided are electrokinetically-altered ioinic aqueous fluids optionally in combination with other therapeutic agents. Particular aspects provide for regulating or modulating intracellular signal transduction associated with said responses by modulation of at least one of cellular membranes, membrane potential, membrane proteins such as membrane receptors, including but not limited to G-Protein Coupled Receptors (GPCR), and intercellular junctions (e.g., tight junctions, gap junctions, zona adherins and desmasomes).

Abstract: The present disclosure encompasses QS-21-based structurally-defined adjuvants to address the need for stronger, safer, and easier-to-access adjuvants. The new compositions can provide tools for addressing long-standing mechanistic questions concerning saponin immune-potentiation through structure-activity-relationship (SAR) studies. Most advantageously, the compounds of the disclosure may be formulated into pharmaceutically acceptable compositions, including vaccines that may be delivered to a subject human or animal subject. The compounds can then act as, for example, an adjuvant to augment an immunological response to a vaccine immunogen.

Abstract: The present invention relates to a method of inducing the production in a patient of anti-HIV antibodies. The method comprises administering to a patient in need thereof an amount of at least one liposome-peptide conjugate in an amount sufficient to effect that induction. The peptide comprises a membrane external proximal region (MPER) epitope and the liposome comprises lysophosphorylcholine or phosphatidylserine.

Abstract: Methods are provided for preparing and delivering an adjuvant for vaccines including lecithin, polymer and one or more additives. The polymer is preferably polyacrylic acid-based. The additive is preferably one or more of a glycoside and a sterol. The method of preparation includes hydrating lecithin and a polymer in saline or water and mixing the lecithin and polymer to form the adjuvant. Additives can be included prior to or after hydration of the lecithin and polymer.

Abstract: For the first time, an O-specific polysaccharide antigen that is a Shigella sonnei, phase I, exopolysaccharide has been produced and characterized, said exopolysaccharide being an authentic natural compound in the form of a bacterial capsular polysaccharide. The exopolysaccharide contains a non-toxic lipid component, namely non-hydroxylated fatty acids, and exhibits low pyrogenicity and high immunogenicity. Effective, highly specific and safe vaccines for the prophylaxis and/or treatment of Shigella sonnei shigellosis are developed on the basis of the above-mentioned exopolysaccharide, as well as pharmaceutical compositions with a broad spectrum of action, in particular, in modulating immune response.

Abstract: Methods for enhancing the suppressive function of myeloid derived suppressor cells (MDSCs) for the treatment of autoimmune diseases using small compounds are disclosed. In certain aspects, the small compounds are glatiramer acetate and mitogen activated protein (MAP) kinase inhibitors. In other aspects, these methods include the administration of exogenous MDSCs or the use of endogenous MDSCs mobilized using stem cell mobilizers. In yet other aspects, compositions containing MDSCs and small compounds of the invention are provided.

Abstract: This disclosure relates to modified Streptococcus pneumonia pneumolysm (PLY) proteins which lack hemolytic activity and can be used as immunogens in an immunogenic composition or vaccine against invasive pneumococcol diseases caused by S. pneumonia The modified pneumolysm proteins comprise amino acid substitutions at threonine 65, glycine 293 and cysteine 428 Nucleic acids, polypeptides encoded thereby, compositions containing the same, methods for using such nucleic acids, polypeptides and compositions are also provided.

Abstract: The invention relates to the identification, sequencing, and isolation of an A25 bacteriophage lysin gene that expresses a protein involved in the lysis of bacterial cells during the phage life cycle. The invention further relates to methods for lysing certain bacteria using lysin, which are useful for example in a diagnostic procedure designed to detect these bacteria.

Abstract: This invention relates to a method for vaccination which is effective for eliciting an enhanced antigen-specific immune response in a mammal, fish or bird. The method is particularly effective for protecting a mammal, fish or bird from a disease including cancer, a disease associated with allergic inflammation, or an infectious disease. Also disclosed are therapeutic compositions useful in such a method.

Abstract: The invention provides immunostimulatory oligonucleotides having at least one CpG dinucleotide and a secondary structure at the 5?- or 3?-end. These oligonucleotides have either reduced or improved immunostimulatory properties. The invention establishes that 5?-terminal secondary structures affect immunostimulatory activity significantly more than those at the 3?-end. The invention also provides methods for increasing or decreasing the immunostimulatory activity of a CpG-containing nucleic acid.

Abstract: The invention provides a method for increasing the bioactivity (e.g. the biosafety and efficacy) of a therapeutic IgE antibody of the invention in the treatment of a patient. Methods of the invention include: i) administering to the patient a therapeutic IgE antibody in combination with at least one bioactivity-enhancing agent, ii) strategic treatment regimens and protocols for the dosing and administration of a therapeutic IgE antibody of the invention, and iii) the use of a therapeutic IgE antibody having a variable region comprising at least one antigen binding region specific for binding an epitope of an antigen wherein the epitope is not highly repetitive or is non-repetitive.

Abstract: The present disclosure generally relates to genetic engineering of bacteria. More particularly, the present disclosure relates to genetic engineering of Gram-negative bacteria expressing different species of lipid A on their surface. In one embodiment, the present disclosure provides for an engineered strain of E. coli according to Table 1. In another embodiment, the present disclosure provides for a lipopolysaccharide purified from an engineered strain of E. coli according to Table 1.

Abstract: Described is an immunostimulatory oligodeoxynucleic acid molecule (ODN) having the structure according to formula (I), wherein any NMP is a 2? deoxynucleoside monophosphate or monothiophosphate, selected from the group consisting of deoxyadenosine-, deoxyguanosine-, deoxyinosine-, deoxycytosine-, deoxyuridine-, deoxythymidine-, 2-methyl-deoxyinosine-, 5-methyl-deoxycytosine-, deoxypseudouridine-, deoxyribosepurine-, 2-amino-deoxyribosepurine-, -6-S-deoxyguanine-, 2-dimethyl-deoxyguanosine- or N-isopentenyl-deoxyadenosine-monophosphate or -monothiophosphate, NUC is a 2? deoxynucleoside, selected from the group consisting of deoxyadenosine-, deoxyguanosine-, deoxyinosine-, deoxycytosine-, deoxyuridine-, deoxythymidine-, 2-methyl-deoxyinosine-, 5-methyl-deoxycytosine-, deoxypseudouridine-, deoxyribosepurine-, 2-amino-deoxyribosepurine-, 6-S-deoxyguanine-, 2-dimethyl-deoxyguanosine- or N-isopentenyl-deoxyadenosine, any X is O or S, a and b are integers from 0 to 100 with the proviso that a+b is between 4 and 150,

Abstract: The application relates to compositions and methods of regulating an immune response comprising inhibitors of TLR7 and/or TLR9, such as immunoregulatory polynucleotides and/or immunoregulatory compounds. The application also relates to compositions and methods for predicting and/or determining responsiveness of a disease to treatment comprising inhibitors of TLR7 and/or TLR9.

Abstract: The invention provides methods for treating asthma by using multiple rounds of administration of ISS over a period of time to confer long term disease modification.

Abstract: Methods of stimulating or enhancing an immune response in a host are disclosed. The methods include contacting a monocyte with 15 kD granulysin thereby producing a monocyte-derived dendritic cell. In one example, the method further includes contacting the monocyte or monocyte-derived dendritic cell with a target antigen, such as a tumor antigen or an autoimmune antigen. In another embodiment, the method includes contacting the monocyte with an additional agent that enhances maturation of dendritic cells or induces immunological tolerance. The methods are of use in vivo, in vitro and ex vivo. In another aspect, the disclosure relates to compositions and methods for the treatment of tumors.

Abstract: Archaeal lipid adjuvants are synthesized by chemically coupling various carbohydrates or anionic polar groups to the free hydroxyl(s) of archaeal lipid cores. Chemically stable lipid cores such as saturated archaeol and caldarchaeol are obtained from appropriate Archaea. Archaeosome lipid vesicles are formulated from the synthetic lipids selected to serve as antigen carriers that target antigen-presenting cells and promote an appropriate immune response to the antigen.

Abstract: Provided herein are immunogenic compositions comprising fusion proteins, the fusion proteins comprising lentivirus gp41 or a fragment thereof, a trimerization or oligomerization motif and an immunoenhancer that elicit potent and broad HIV neutralizing antibody responses in the immunized hosts. Also disclosed are methods of making and using the immunogenic compositions.

Abstract: Provided are formulations, compositions and methods for delivering biological moieties such as modified nucleic acids into cells to modulate protein expression. Such compositions and methods include the delivery of biological moieties, and are useful for production of proteins.

Abstract: The present invention is drawn to methods of predicting prognosis of, and therapeutic response in, carcinoma of the lung.

Abstract: Immunogenic compositions are disclosed which comprise microparticles that comprise a biodegradable polymer, an immunological adjuvant and a tocol-family compound. Methods of making and using such microparticle compositions are also disclosed.

Abstract: Recombinant immunogenic compositions, and methods for the manufacture and use, are provided for the prevention and treatment of intracellular pathogen diseases in humans and animals. The recombinant immunogenic compositions express high levels of recombinant proteins in vectors that do not harbor an antibiotic resistance marker (“unmarked”).

Abstract: The present invention provides compositions and systems for delivery of nanocarriers to cells of the immune system. The invention provides nanocarriers capable of stimulating an immune response in T cells and/or in B cells. The invention provides nanocarriers that comprise an immunofeature surface having a plurality of nicotine moieties. The invention provides pharmaceutical compositions comprising nanocarriers. The present invention provides methods of designing, manufacturing, and using nanocarriers and pharmaceutical compositions thereof. For example, the present invention describes nanocarriers capable of eliciting an immune response and the production of anti-nicotine antibodies.

Abstract: Compositions comprising NKT cell agonist compounds and a physiologically acceptable vehicle are provided. Methods of stimulating an NKT cell and enhancing an immune response are also disclosed. Further provided are vaccine preparations comprising NKT cell agonist compounds.

Abstract: The invention provides a method for treating or preventing preterm labor in pregnant female subjects. The method comprises the step of administering a therapeutically effective amount of a Toll-like Receptor 9 antagonist sufficient to prevent the activation of Toll-like Receptor 9 by fetal DNA. The invention further provides compositions comprising a Toll-like Receptor 9 antagonist for use in the methods of the invention. The compositions and methods of the present invention enhance gestation and therefore improve neonatal morbidity and mortality.

Abstract: Antimicrobial and/or anti-inflammatory peptide compositions and therapeutic uses thereof are provided. The peptides and analogs or derivatives thereof may be used as an antimicrobial agent and/or as an anti-inflammatory agent. In certain embodiments, the peptides are cationic peptides. The peptides are useful for the treatment of inflammatory diseases, such as microorganism-caused infections, acne, and psoriasis. The peptides and peptide formulations may be used topically or parenterally.

Abstract: The inventions provided herein generally relate to compositions and methods for controlling response of immune cells to at least one stimulus or condition (e.g., but not limited to, tissue damage, an implantable device and/or a cytokine) in vitro or in vivo. The compositions described herein comprise a biomaterial (e.g., a silk fibroin-based matrix) comprising at least one immune cell-modulating agent in an effective amount sufficient to selectively alter activation state of at least one type of immune cells (e.g., but not limited to macrophages and dendritic cells). Accordingly, in some embodiments, the compositions and methods described herein can be used to selectively skew macrophages to M1 phenotype and/or M2 phenotype and thereby control the inflammatory and/or regenerative responses of the macrophages, e.g., to repair and/or regenerate a target tissue.

Abstract: The present invention is directed to the examination of the pattern of immunodominant T cell epitopes in the E6 protein of Human Papilloma virus and its further characterization in terms of its amino acid sequence and Human Leukocyte Antigen restriction. These epitopes are identified based on their ability to induce specific T cell responses and therefore, are important as sources of antigens for immunotherapies to treat cervical and other cancers. The present invention contemplates identifying a number of similar epitopes restricted by a wide variety of Human Leukocyte Antigen types so that they can be used together to develop preventative or therapeutic vaccines, which can be used for the general human population. The present invention also contemplates using E6 peptides of Human Papilloma virus as a diagnosis method to predict the probability of developing persistent cervical neoplasia in an individual.