Abstract: The present invention is directed to a method for extracting hepatitis A virus (HAV) antigen from a cell culture as well as a use of a composition for extracting hepatitis A virus (HAV) antigen from a cell culture.

Abstract: A novel process for the purification of recombinant protein expressed as particle is herewith described. In this purification process, the protein is purified by hydrophobic interaction. The interaction of this protein step resulted in an increase in recovery and purity from 15%-80%. The protein further purified has its application in vaccines and pharmaceuticals.

Abstract: Biopharmaceuticals, such as vaccine agents and probiotics, are encapsulated in carbohydrate-glass particles and embedded in an amorphous polymer substrate to produce polymeric compositions containing ambient-temperature stable biopharmaceuticals for syringeless administration to patients such as via dissolvable films, micro-needle patches and similar medical delivery devices. The amorphous polymer substrate is soluble in both water and volatile organic solvents, yet the carbohydrate-glass particles are insoluble in organic solvents. A method for formulation of the polymeric compositions containing ambient-temperature stable biopharmaceuticals includes combining biopharmaceuticals encapsulated in carbohydrate-glass particles with polymer in organic solvent and evaporating the organic solvent to yield a water soluble polymeric composition containing ambient-temperature stable biopharmaceuticals.

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

Abstract: Vitreous compositions of an antigen and adjuvant, and methods for making the compositions are disclosed. Also disclosed are pharmaceutically acceptable formulations of the vitreous compositions, reconstituted liquid formulations of the vitreous compositions, vaccine compositions, and kits containing the vitreous compositions. Also disclosed are devices for administering the vitreous compositions to mammals and methods for eliciting an immune response in mammals by administering the compositions.

Abstract: Methods are disclosed for producing defective ribosomal products (DRiPs) in blebs (DRibbles) by contacting cells with a proteasome inhibitor, and in some examples also an autophagy inducer, thereby producing treated cells. DRibbles can be used to load antigen presenting cells (APCs), thereby allowing the APCs to present the DRiPs and antigenic fragments thereof. Immunogenic compositions that include treated cells, isolated DRibbles, or DRibble-loaded APCs are also disclosed. Methods are also provided for using treated cells, isolated DRibbles, or DRibble-loaded APCs to stimulate an immune response, for example in a subject. For example, DRibbles obtained from a tumor cell can be used to stimulate an immune response against the same type of tumor cells in the subject. In another example, DRibbles obtained from a pathogen-infected cell or cell engineered to express one or more antigens of a pathogen can be used to stimulate an immune response against the pathogen in the subject.

Abstract: Disclosed are a construct for expressing a rotavirus antigen complex loaded with a heterologous virus epitope, a vaccine composition containing the rotavirus antigen complex, a virus-like particle of rotavirus containing the rotavirus antigen complex, and a vaccine composition containing the virus-like particle of rotavirus. According to the present disclosure, an antigen complex containing a rotavirus antigen as well as a heterologous virus epitope and a virus-like particle of rotavirus containing the antigen complex can be produced in large scale at low cost. Thus, the present disclosure may be applied for research and development of novel complex vaccines for rotavirus and heterologous virus.

Abstract: The disclosure relates to a composition added to animal feed used in combination with a vaccine to enhance the effectiveness of the vaccine. Amongst other effects, the composition raises the titer of antibodies to the vaccine.

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: 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 provides a new means of restoring the immune system in aging and immunocompromised individuals using an antioxidant nutraceutical. The nutraceutical stimulates the aging immune system through the Nrf2 master gene regulatory pathway. The invention is based in part on the discovery that the Nrf2 has antioxidant and immune restorative activity. The nutraceutical improves function of both the innate and adaptive immune systems.

Abstract: Nucleic acid oligomeric sequences and in vitro nucleic acid amplification and detection methods for detecting the presence of HAV RNA sequences in samples are disclosed. Kits comprising nucleic acid oligomers for amplifying and detecting HAV nucleic acid sequences are disclosed.

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: The present invention relates to a process for stabilizing an adjuvant containing vaccine composition, an adjuvanted vaccine composition in dry form and in particular a process for stabilizing an influenza vaccine composition, particularly an adjuvanted influenza vaccine composition in dry form.

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 invention discloses pharmaceutical compositions in liquid form comprising a peptide with the amino acid sequence KLKL5KLK and an oligodeoxynucleotide with the nucleic acid sequence (dIdC)13 and wherein the peptide and the oligodeoxynucleotide are present as sterile-filterable nanoparticles in the composition, thereby forming a suspension, characterized in that the mean particle size of the solid particles is less than 1 ?m.

Abstract: The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated form of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.

Abstract: The disclosure relates to immunizing agents and devices.

Abstract: Mucosal immunization using one or more antigens following parenteral administration of the same or different antigens is described.

Abstract: The present invention is directed to a method for promoting or stimulating a cell-mediated immune response to an antigen, by administering a target antigen (such as a protein) with a transport factor that contains a fragment of a bipartite protein exotoxin, but not the corresponding protective antigen. Preferred transport factors include the protective antigen binding domain of lethal factor (LFn) from B. anthracis, consisting of amino acids 1-255, preferably a fragment of at least 80 amino acids that shows at least 80% homology to LFn, and a fragment of about 105 amino acids from the carboxy portion that does not bind PA. The target antigen can include any molecule for which it would be desirable to elicit a CMI response, including viral antigens and tumor antigens.

Abstract: Immunogenic compositions containing phospholipid adjuvants, including microparticle and emulsion compositions. According to one aspect of the invention, an immunogenic microparticle composition is provided comprising: water; a polymer microparticle; an antigen adsorbed to the microparticle; and a phospholipid compound, e.g., a synthetic phospholipid compound comprising: (i) one or more phosphoryl groups independently selected from a phosphato group and a phosphodiester group; (ii) a plurality of linear alkane groups. According to another aspect of the invention an immunogenic emulsion composition is provided that comprises: water; a metabolizable oil; an emulsifying agent; an antigen; and a phospholipid compound, e.g., a synthetic phospholipid compound like that above. The emulsion composition is an oil-in-water emulsion having oil and aqueous phases, in which the oil phase is in the form of oil droplets, substantially all of which are less than 1 micron in diameter.

Abstract: The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated form of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.

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

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

Abstract: Disclosed are dosage forms and related methods, that include a first population of synthetic nanocarriers that have one or more first antigens coupled to them, one or more second antigens that are not coupled to the synthetic nanocarriers, and a pharmaceutically acceptable excipient.

Abstract: Nucleic acid oligomeric sequences and in vitro nucleic acid amplification and detection methods for detecting the presence of HAV RNA sequences in samples are disclosed. Kits comprising nucleic acid oligomers for amplifying and detecting HAV nucleic acid sequences are disclosed.

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

Abstract: The present application provides compositions and methods useful for treating hepatitis A. In particular, while hepatitis A vaccines are currently limited to parenteral administration routes (i.e., intramuscular injection), we have identified compositions that induce a protective response when administered orally.

Abstract: The present invention relates to a method for treating an infection or disease or lesion, in particular an HPV infection. Furthermore, it relates to a vaccine for treating a Human Papillomavirus (HPV) infection or an associated disease or lesion in a subject.

Abstract: The present invention relates to vaccines comprising a bacteriophage which has been engineered to express an immunogenic protein/peptide and wherein the surface of the bacteriophage has not been modified to contain proteins/peptides designed to target the phage to receptors on the surface of specific cell types.

Abstract: The invention provides chimeric flavivirus vectors including foreign peptides inserted into the envelope proteins of the vectors and methods of using these vectors.

Abstract: The present invention provides methods of vaccination as well as pharmaceutical combinations and kits for enhancing vaccine effectiveness, including for immunodeficient or immunecompromised patients, including non-responders and low-responders to vaccination. As disclosed herein, the invention relates to administering a vaccine and a regimen of thymosin alpha peptide so as to provide higher antibody titers, speed the development of such antibody titers, and/or to provide for a longer duration of such antibody titers, thereby providing a greater protective effect. In another aspect, the invention allows for reducing a vaccine dose, such as an influenza vaccine dose, by administration of a thymosin peptide regimen.

Abstract: The present invention relates to an adjuvant derived from human lymphocytes. The adjuvant can be used in combination with traditional vaccines or cancer immunotherapy, to enhance the response of the patient's immune system to the vaccine or other immunotherapeutic agent. The adjuvant is derived from the supernatant collected from cultured activated lymphocytes.

Abstract: The invention provides an immunogenic composition comprising at least one antigen in association with micropar-tides, wherein the microparticles are in the same size range as viruses. In addition the invention also provides vaccine compositions and methods of eliciting immune responses in a subject.

Abstract: Disclosed herein are methods of modulation of the viability of a cell. Further disclosed herein are methods of modulating an immune response. Further disclosed herein are methods of identifying agents capable of modulation of the viability of a cell or an immune response. Further disclosed herein are agents and compositions capable of modulation of the viability of a cell or an immune response.

Abstract: The invention relates to compositions and methods related to the treatment of viral infection. In some embodiments, the invention relates to the treatment of hepatitis C viral infection. In further embodiments, the invention relates to methods of administering oligonucleotide compositions for treating viral infections. In still further embodiments, the invention relates to the administration of antiviral agents, corticosteroids and immunomodulatory agents. In additional embodiments, the invention relates to the manipulation of immunostimulatory motifs within the oligonucleotides.

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

Abstract: A method of detecting osteoporosis in a mammalian is disclosed herein which includes: a) obtaining a sample of a bone related tissue or cells; and b) measuring the concentration of at least a marker which is either bacteria, bacteria produced factors, or HSPs. The method may further include comparing the concentration with concentrations from the same individual over a period of time or against a standard concentration. The marker may be a bacteria, a chaperone molecule, or a bacteria produced. Also provided herein is a method of treating or preventing osteoporosis caused by a bone disease which includes administering to a mammalian subject a therapeutically effective amount of a formulation which is either an HSP antigenic formulation or a bacterial antigenic formulation. The osteoporosis can be caused by a bone disease induced by bone infectious agents such as viruses, bacteria, fungi, protozoa and parasites.

Abstract: The present invention provides a cellular vaccine for therapeutic or prophylactic treatment of a pathological condition, the vaccine comprising or consisting of a population of CD 4+ T cells modified such that they contain an antigenic component, and/or a nucleic acid molecule encoding an antigenic component thereof, wherein the T cells are (a) activated, or capable of being activated, and (b) apoptotic, or capable or being made apoptotic. The invention further provides an adjuvant composition for use in a method of vaccination, the composition comprising or consisting of a population of T cells, wherein the T cells are (a) activated, or capable of being activated, and (b) apoptotic, or capable or being made apoptotic.

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: A method for obtaining an immune response to a non-enteric pathogen antigen (NEPA) such as hepatitis B surface antigen (HBsAg) by feeding the antigen in a plant material to an animal that is immunoreceptive to the NEPA. It has now been discovered that the animal may be made immunoreceptive to the NEPA such as HBsAg by prior primary immunization. When the animal is made immunoreceptive by a prior, e.g. primary, immunization, an immune response to the NEPA may be boosted in the animal by feeding the animal the plant material containing the NEPA. For example, an animal, e.g. a human, that previously had a positive response to primary immunization against hepatitis B, can have a booster response to HBsAg by feeding the animal the antigen in a plant material. The plant material is a substance comprising a physiologically acceptable plant material, especially potatoes, containing the NEPA, e.g. hepatitis B surface antigen (HBsAg). The NEPA, e.g.

Abstract: The present invention relates to an adjuvant comprising a lipopeptide and poly I:C. When the adjuvant of the present invention is used, the level of antigen specific antibody induction is synergistically increased and Th1 type immune response is also induced. Therefore, the adjuvant of the present invention can be very effectively used as an adjuvant in the formulation of preventive and therapeutic vaccines for viral or parasitic infection and cancer.

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: Nucleic acid oligomeric sequences and in vitro nucleic acid amplification and detection methods for detecting the presence of HAV RNA sequences in samples are disclosed. Kits comprising nucleic acid oligomers for amplifying and detecting HAV nucleic acid sequences are disclosed.

Abstract: The present invention relates to the combination of antigens directed against bacteria and viruses, their uses and the preparation of medicaments in order to confer protection against infectious diseases. In particular, the invention relates to a combination vaccine comprising at least one antigen of Clostridium tetani, at least one antigen from Corynebacterium diphtheriae, and at least one antigen from the TBE-flavivirus suitable to confer seroprotection against diseases and medical conditions caused by these pathogenic organisms.

Abstract: The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated forms of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.

Abstract: Vitreous compositions of an antigen and adjuvant, and methods for making the compositions are disclosed. Also disclosed are pharmaceutically acceptable formulations of the vitreous compositions, reconstituted liquid formulations of the vitreous compositions, vaccine compositions, and kits containing the vitreous compositions. Also disclosed are devices for administering the vitreous compositions to mammals and methods for eliciting an immune response in mammals by administering the compositions.

Abstract: A vaccination method utilizes a pharmaceutical combination for enhancing vaccine effectiveness. The method utilizes an immune response-triggering vaccine capable of stimulating production in an immunodefficicent animal of antibodies to a disease-causing agent foreign to the animal. As an adjuvant, a vaccine effectiveness-enhancing amount of an immunomodulator compound is administered, which enhances production and affinity of the antibodies in the animal, in response to the vaccine.

Abstract: The present invention relates to novel methods of vaccination and vaccine delivery.

Abstract: An improved method for the manufacture of an oil-in-water emulsion involves circulation of emulsion components between a first container and a second container via a homogenizer and/or via a microfluidization device. Usefully, all of the emulsion components from the first container are emptied before being returned.