Abstract: Pesticidal proteins exhibiting inhibitory, suppressive, and toxic activity against Lepidopteran pest species are disclosed, and include, but are not limited to, TIC4064 and TIC4064 amino acid sequence variants. DNA constructs are provided which contain a recombinant nucleic acid sequence encoding one or more of the disclosed pesticidal proteins. Transgenic plants, plant cells, seed, and plant parts resistant to Lepidopteran infestation are provided which contain recombinant nucleic acid sequences encoding the pesticidal proteins of the present invention. Methods for detecting the presence of the recombinant nucleic acid sequences or the proteins of the present invention in a biological sample, and methods of controlling Lepidopteran species pests using any of the TIC4064 and TIC4064 amino acid sequence variant pesticidal proteins are also provided.

Abstract: The present invention relates to the field of bacterial Surface (S)-layer proteins, in particular to compounds capable of disrupting the bacterial S-Layer, specifically the S-Layer of Bacillus anthracis. More particularly, the invention provides for single domain antibodies for diagnosis and treatment of infection caused by pathogens with an S-Layer, in particular of Bacillus anthracis infection. The invention relates to S-Layer protein binding agents inhibiting bacterial growth and interrupting S-Layer assembly, useful in the treatment of bacterial infection, more specifically treatment of anthrax disease.

Abstract: The present subject matter provides, inter alia, compositions and methods comprising inactivated, non-viable, or dead Bacillus coagulans bacteria such as whole dead bacterial spores and/or cells and/or particles that comprise inactivated, non-viable, or dead Bacillus coagulans bacteria. Compositions and methods comprising Bacillus coagulans peptidoglycan and/or lipoteichoic acid are also provided.

Abstract: Provided is a method of improving urogenital health, including administering to a subject a composition including an effective amount of a Lactobacillus johnsonii strain deposited under the accession number of DSM 33288 or a metabolite thereof. The Lactobacillus johnsonii strain, which is a probiotic, and metabolites thereof inhibit the growth of common pathogenic bacteria and fungi causing genitourinary tract infections, thereby reducing the risk of genitourinary tract infections or alleviating symptoms thereof. Also provided is a composition for improving urogenital health which includes the Lactobacillus johnsonii strain.

Abstract: Combinations of probiotic compositions are described which are beneficial for human hosts in reducing gas and bloating, stomach acidity, and constipation also capable of boosting the immune capacity. The compositions comprise blends including B. coagulans, B. subtilis, and B. clausii in combination with magnesium stearate, magnesium hydroxide, and simethicone. The combination probiotic compositions of the present invention behave in a synergistic manner in their nature of action both in-vitro and in-vivo. The combination probiotic compositions of the present invention are also very stable for comparatively greater amounts of time period.

Abstract: Methods, kits and reagents are provided for increasing the sensitivity of detecting the presence or absence of endospores by increasing the available protein for detection. The methods are fast and amendable to testing in a non-laboratory setting and use a protein detection reagent and solid microparticles.

Abstract: The invention concerns constructs and libraries comprising antibody surrogate light chain sequences. In particular, the invention concerns constructs comprising VpreB sequences, optionally partnered with another polypeptide, such as, for example, antibody heavy chain variable domain sequences, and libraries containing the same.

Abstract: The present invention shows that intranasal administration of E1/E3-defective adenovirus particles may confer rapid and broad protection against viral and bacterial pathogens in a variety of disease settings. Protective responses lasted for many weeks in a single-dose regimen in animal models. When a pathogen-derived antigen gene was inserted into the E1/E3-defective adenovirus genome, the antigen-induced protective immunity against the specific pathogen was elicited before the adenovirus-mediated protective response declined away, thus conferring rapid, prolonged, and seamless protection against pathogens. In addition to E1/E3-defective adenovirus, other bioengineered non-replicating vectors encoding pathogen-derived antigens may also be developed into a new generation of rapid and prolonged immunologic-therapeutic (RAPIT).

Abstract: Provided is a method for treatment of atopic dermatitis and infectious dermatitis with biological spa therapy. The method seeks to cure or alleviate symptoms of atopic dermatitis by bathing in a bathwater containing, as dominant bacteria, not less than 105 Bacillus bacteria per 1 mL of the bathwater.

Abstract: Disclosed herein is a peptide substrate that is cleaved specifically by anthrax lethal factor (LF), and assays for detecting the presence of anthrax lethal factor in a sample using the peptide substrate. In some cases, the sample may be obtained from an individual at an early stage of an anthrax infection. Kits that include the peptide substrate and that find use in carrying out the assays are also disclosed.

Abstract: A method of identifying a subject with increased risk of colorectal cancer includes obtaining a biological sample from the subject, measuring the level of Fusobacterium nucleatum in the biological sample, and comparing the measured level to a control level, wherein an increased measured level compared to the control level is indicative of increased risk of colorectal cancer in the subject.

Abstract: The present invention relates to an adjuvant composition containing poly-gamma-glutamic acid-chitosan nanoparticles and a vaccine composition containing the adjuvant composition, and more particularly to an adjuvant composition containing nanoparticles prepared by ionic bonding between poly-gamma-glutamic acid having ensured safety and chitosan, and a vaccine composition containing the poly-gamma-glutamic acid-chitosan nanoparticles and an antigen. The adjuvant containing the poly-gamma-glutamic acid-chitosan nanoparticles has little or no toxicity and side effects and is added to human or animal vaccines for the prevention and treatment of viral and bacterial infections and cancers to increase the production of antibodies.

Abstract: Regions of Bacillus anthracis protective antigen are provided representing epitopes recognized by antibodies in subjects that have acquired immunity to Bacillus anthracis infection. The recognition of these epitopes correlates with autoimmunity in a subject. Also provided are vaccines that include at least one of these epitopes that when administered to a subject provide improved acquired immunity.

Abstract: Provided are immunogenic compositions and methods for eliciting an immune response against B. anthracis and other bacteria that contain 3-methyl-3-hydroxybutyrate- or 3-hydroxybutyrate-substituted saccharides. Conjugates of 3-methyl-3-hydroxybutyrate- or 3-hydroxybutyrate-substituted saccharides elicit an effective immune response against B. anthracis spores in mammalian hosts to which the conjugates are administered.

Abstract: A microprojection array is provided, comprising an approximately planar base and a plurality of microprojections, wherein the array comprises a vaccine and a polymeric material. The array may have multiple layers. The vaccine may be placed in only one layer. In another embodiment of the invention, a method of preventing a disease is provided, comprising insertion into the skin of a patient an array of microprojections comprising a layer which comprises a vaccine for that disease and a polymer.

Abstract: The present invention relates to monoclonal antibodies that bind or neutralize anthrax lethal factor (LF), edema factor (EF), and/or protective antigen (PA). The invention provides such antibodies, fragments of such antibodies retaining anthrax toxin-binding ability, fully human or humanized antibodies retaining anthrax toxin-binding ability, and pharmaceutical compositions including such antibodies. The invention further provides for isolated nucleic acids encoding the antibodies of the invention and host cells transformed therewith. Additionally, the invention provides for prophylactic, therapeutic, and diagnostic methods employing the antibodies and nucleic acids of the invention.

Abstract: The invention relates to an insecticidal protein, its gene encoding and the uses thereof. The protein comprises: (a) a protein consisting of an amino acid sequence shown by SEQ ID NO:2; or (b) a protein derived from (a) consisting of an amino acid sequence by substitution, deletion, or addition of one or more amino acid residues of the amino acid sequences in (a), and having insecticidal activity; or (c) a protein generated by the expression of nucleic acid molecules containing a nucleotide sequence of SEQ ID NO:1; or (d) a protein generated by the expression of nucleic acid molecules containing a complementary sequence that hybridized with SEQ ID NO:1 under stringent conditions; or (e) a protein generated by the expression of nucleic acid molecules that contain nucleotide sequences isocoding with the nucleotide sequences in (d). The insecticidal protein of the invention has high expression level and strong toxicity against pests.

Abstract: The invention relates to an insecticidal protein, its gene encoding and the uses thereof. The protein comprises: (a) a protein consisting of an amino acid sequence shown by SEQ ID NO:2 or a sequence of amino acid residuses at positions 1 to 640 thereof; or (b) a protein derived from (a) by substitution, deletion, or addition of one or more amino acid residuses of the amino acid sequences in (a), and having insecticidal activity; or (c) a protein generated by the expression of nucleic acid molecules containing a sequence of amino acid residuses at the positions 1 to 1920 of SEQ ID NO:1; or (d) a protein generated by the expression of nucleic acid molecules containing a complementary sequence that hybridized with the sequence of nucleotides at the positions 1 to 1920 of SEQ ID NO:1 under stringent conditions. The protein has high expression level and strong toxicity against pests.

Abstract: A microprojection array is provided, comprising an approximately planar base and a plurality of microprojections, wherein the array comprises a vaccine and a polymeric material. The array may have multiple layers. The vaccine may be placed in only one layer. In another embodiment of the invention, a method of preventing a disease is provided, comprising insertion into the skin of a patient an array of microprojections comprising a layer which comprises a vaccine for that disease and a polymer.

Abstract: The present invention encompasses methods, assays and kits for the detection of pathogenic bacteria in a patient and for the differential diagnosis of pulmonary diseases associated with pathogenic bacteria from pulmonary diseases not associated with pathogenic bacteria.

Abstract: The present invention provides methods and compositions for the stimulation of immune responses. Specifically, the present invention provides methods of inducing an immune response against one or a plurality of pathogens (e.g., vaccinia virus, H5N1 influenza virus, Bacillus anthracis, C. botulinum, Y. pestis, Hepatitis B, and/or HIV, etc.) in a subject (e.g., a human subject) and compositions useful in such methods (e.g., immunogenic composition comprising nanoemulsion and one or a plurality of pathogens (e.g., inactivated by the nanoemulsion) and/or pathogen products and/or pathogen components). 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: An accelerating agent for elimination of dioxins which comprises, as an active ingredient, a microorganism having an activity of accelerating elimination of dioxins in the body to the outside of the body.

Abstract: Disclosed are a highly efficient method for production of heterologous proteins performed by utilizing microorganisms, as well as fusion proteins, and an antiserum. The method includes a method for production of a protein (A) in the form of a fusion protein, comprising the steps of (a) preparing a DNA which codes for a fusion protein comprising the peptide chain forming the protein (A) and the C-terminal peptide or its fragment (B) of the Cry proteins produced by Bacillus thuringiensis, and (b) introducing the DNA into a host bacterium to transform the same, and (c) allowing the fusion protein to be expressed in the transformed host bacterium, as well as a method for production of the protein (A) itself comprising a further step of removing the peptide chain (B) from the fusion protein obtained.

Abstract: The invention provides TLR agonists and conjugates thereof useful in vaccines and to prevent, inhibit or treat a variety of disorders including pathogen infection and asthma.

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: Vaccines for conferring immunity in mammals to infective pathogens are provided, as well as vectors and methods for plastid transformation of plants to produce protective antigens and vaccines for oral delivery. The invention further provides transformed plastids having the ability to survive selection in both the light and the dark, at different developmental stages by using genes coding for two different enzymes capable of detoxifying the same selectable marker, driven by regulatory signals that are functional in proplastids as well as in mature chloroplasts. The invention utilizes antibiotic-free selectable markers to provide edible vaccines for conferring immunity to a mammal against Bacillus anthracis, as well as Yersina pestis. The vaccines are operative by parenteral administration as well. The invention also extends to the transformed plants, plant parts, and seeds and progeny thereof. The invention is applicable to monocot and dicot plants.

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: Formulations of anthrax protective antigen are provided that are stable in storage for prolonged periods. Methods of using the formulations to prepare vaccine are also provided. Vaccines comprising the formulations are useful, for example, to protect against anthrax infection.

Abstract: Cysteine-specific radiolabeled Cry1Fa protein retains insecticidal activity against insect pests and binds to insect brush border membrane vesicle receptors in a saturable manner. The biologically-active radiolabeled Cry1Fa protein is useful in competitive binding assays with other Cry toxins.

Abstract: The invention relates to vaccine compositions having a carrier protein and an antigen of interest entrapped in a complex, methods of making such vaccines, and methods of vaccine administration.

Abstract: The invention provides an isolated Bacillus cereus sensu lato strain, selected from Bacillus anthracis, Bacillus cereus and Bacillus thuringiensis, in which the htrA gene or any part thereof is silenced, and vaccines comprising the same.

Abstract: The characterization and isolation of F20G75, F20G76 and F20G77, anti-PA monoclonal antibodies which also have neutralizing activities is described. The monoclonal antibodies may be used as a pharmaceutical composition for treating individuals suspected of or at risk of or having a Bacillus anthracis infection. The monoclonal antibodies bind to a specific region comprising amino acids 311-316 of PA, ASFFDI or a larger fragment comprising amino acids 301-330 of PA, SEVHGNAEVHASFFDIGSSVSAGFSNSNSS. Vaccines comprising these peptides may be used to immunize individuals against Bacillus anthracis infection.

Abstract: The present invention provides monoclonal antibodies which are highly specific for Bacillus spores. Also provided are peptides derived from those monoclonal antibodies. Both the antibodies and peptides are highly specific and can discriminate between spores of potentially lethal organisms such as Bacillus anthracis and other harmless but closely related bacilli and provide a very powerful tool in the construction of detection instruments as counter measures.

Abstract: The present invention shows that intranasal administration of E1/E3-defective adenovirus particles may confer rapid and broad protection against viral and bacterial pathogens in a variety of disease settings. Protective responses lasted for many weeks in a single-dose regimen in animal models. When a pathogen-derived antigen gene was inserted into the E1/E3-defective adenovirus genome, the antigen-induced protective immunity against the specific pathogen was elicited before the adenovirus-mediated protective response declined away, thus conferring rapid, prolonged, and seamless protection against pathogens. In addition to E1/E3-defective adenovirus, other bioengineered non-replicating vectors encoding pathogen-derived antigens may also be developed into a new generation of rapid and prolonged immunologic-therapeutic (RAPIT).

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: Disclosed and claimed is a method of non-invasive immunization in an animal and/or a method of inducing a systemic immune response or systemic therapeutic response to a gene product. The skin of the animal is contacted with a non-replicative vector chosen from the group of bacterium, virus, and fungus, wherein the vector comprises and expresses a nucleic acid molecule encoding the gene product, in an amount effective to induce the response.

Abstract: The invention relates to improved methods of producing and recovering B. anthracis protective antigen (PA), especially modified PA which is protease resistant, and to methods of using of these PAs or nucleic acids encoding these PAs for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of, B. anthracis bacterial infections and which are useful to prevent and/or treat illnesses caused by B. anthracis, such as inhalation anthrax, cutaneous anthrax and gastrointestinal anthrax.

Abstract: Provided is a modified bacteriophage capable of infecting a target bacterium, which bacteriophage includes an ?/? small acid-soluble spore protein (SASP) gene encoding a SASP which is toxic to the target bacterium, wherein the SASP gene is under the control of a constitutive promoter which is foreign to the bacteriophage and the SASP gene.

Abstract: A surface expression vector for preparing HPV immunogenic compositions, in which the surface expression vector contains a gene encoding a repE mutant protein having an amino acid sequence of SEQ ID NO: 1, a promoter, a poly-gamma-glutamate synthetase complex gene, and a gene which is linked with the poly-gamma-glutamate synthetase complex gene and encodes a tumor induction-associated antigen protein of human papillomavirus. An expression vector constitutively expressing a high level of the human papillomavirus (HPV) antigen protein is provided. Also, a recombinant lactic acid bacteria, transformed with the expression vector and expressing the HPV antigen protein on the surface thereof, and a composition comprising the recombinant lactic acid bacteria are provided. The recombinant lactic acid bacteria and the composition are very effective as a immunogenic composition for the treatment of cervical cancer, because they can be applied orally or directly to the vagina.

Abstract: The present invention relates to immunogenic compositions containing one or more antigens of interest, one or more carrier proteins, and one or more polycations, wherein the antigen of interest is entrapped with cross-linked carrier protein matrix and one or more polycations, methods of making such vaccines, and methods of vaccine administration.

Abstract: The present invention relates to a method of coating a spore with one or more therapeutic agents. The present invention also relates to a coated spore obtained by the method of the present invention and the use of the coated spore as a vaccine.

Abstract: One major problem in diagnosis methods presently available for anthrax is that these methods require several days to produce a result. The only existing treatment for anthrax requires administration soon after infection at a time when patients are exhibiting only mild flu-like symptoms. Thus, a patient may be days beyond the time when treatment would be effective by the time a diagnosis is made. The present invention reduces diagnosis time to as little as four hours providing same day identification of anthrax radically increasing the odds of delivering proper treatment and patient recovery. The rapid identification of anthrax lethal factor activity exhibited by the instant invention is also amenable to in vivo screening protocols for the discovery and development of anthrax vaccines and lethal factor inhibitors. The instant invention isolates and concentrates lethal factor and lethal toxin from nearly any biological sample.

Abstract: The present invention creates a biologically protected or enhanced space in vivo in a mammal to allow the mammal's immune system and/or other biological processes to function properly in order to treat autoimmune diseases. In particular, the biologically protected/enhanced space allows biological processes to occur that can therapeutically treat Type I diabetes. The biologically enhanced/protected space can also be used to promote growth of specific cells such as insulin producing islet cells of the pancreas. Microfluidic devices can also be used to remove soluble TNF receptors and autoreactive T Cells in treating autoimmune diseases. Additionally, microfluidic devices can be used to remove blood glucose, soluble insulin receptors and insulin-like growth factor (IGF) from blood in the treatment of adult onset (Type II) diabetes.

Abstract: The present invention relates to novel nucleic acid molecules for producing target polypeptides in plant cells. More specifically, the novel nucleic acid molecules comprise a minireplicon derived from a Closteroviridae virus and heterologous polynucleotides encoding the target polypeptides. Also provided are compositions comprising the target polypeptides and uses thereof.

Abstract: The invention relates to the use of lactic acid-producing bacteria to boost the immune system.

Abstract: The present invention relates to immunogenic compositions for modulating the immune system, comprising a therapeutically effective quantity of two or more immuno-active antigenic agents with pathogen-associated molecular patterns (PAMPs) and/or danger-associated molecular patterns (DAMPs) and one or more physiologically acceptable carriers, excipients, diluents or solvents. The immunogenic compositions according to the present invention are used for producing medicaments for preventing and/or treating, and for preventing and/or treating infectious diseases, auto-immune diseases, allergic diseases, inflammation, arthritis, inflammatory diseases, transplant rejection, affections caused by vascular disorders, diseases caused by haemorrhagic or ischaemic cardiovascular accidents, ischaemia, heart attack and haemorrhagia leading to tissue destruction, heart, kidney, respiratory or liver insufficiency, cancer, malign and benign tumours and neoplasia.

Abstract: The invention provides a vaccine injection, which includes a vaccine and a Traditional Chinese medicinal adjuvant in a mass ratio of 1:0.5-1:10, or a vaccine, a Traditional Chinese medicinal adjuvant and an aluminum adjuvant in a mass ratio of 1:0.5:2.5-1:10:20. The vaccine injection is in the form of powders, and the size of the powders is between 10 and 120 micrometers. The vaccine injection of the present invention is particularly suitable for the needle free injection technology. The invention also provides a preparation method for the vaccine injection.

Abstract: The present invention relates to monoclonal antibodies that bind or neutralize anthrax lethal factor (LF), edema factor (EF), and/or protective antigen (PA). The invention provides such antibodies, fragments of such antibodies retaining anthrax toxin-binding ability, fully human or humanized antibodies retaining anthrax toxin-binding ability, and pharmaceutical compositions including such antibodies. The invention further provides for isolated nucleic acids encoding the antibodies of the invention and host cells transformed therewith. Additionally, the invention provides for prophylactic, therapeutic, and diagnostic methods employing the antibodies and nucleic acids of the invention.

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

Abstract: Provided are immunogenic compositions and methods for eliciting an immune response against B. anthracis and other bacteria that contain 3-methyl-3-hydroxybutyrate- or 3-hydroxybutryate-substituted saccharides. Conjugates of 3-methyl-3-hydroxybutyrate- or 3-hydroxybutryate-substituted saccharides elicit an effective immune response against B. anthracis spores in mammalian hosts to which the conjugates are administered.