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 provides methods and compositions for the stimulation of immune responses. Specifically, the present invention provides immunogenic compositions and methods of using the same to induce immune responses (e.g., immunity (e.g., protective immunity)) against Hepatitis B virus (HBV)). 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: This invention provides novel processes for therapeutic applications, including the treatment of subjects carrying infectious agents or having impaired autoimmunity or impaired immune condition. The therapeutic applications disclosed herein are also directed at the treatment of cancerous subjects with malignant tumors containing cancerous cells or malignant or cancerous cells. Vaccination processes for preventing infections in subjects are also provided. The novel processes comprise introducing into or adminstering to a subject one or more antigens, or trained or adopted immune cells. These antigens or immune cells are capable of establishing or increasing at least one first specific immune response and decreasing at least one second specific immune response. Such responses include components, such as cellular immune reaction elements, humoral immune reaction elements and cytokines, the latter also encompassing interferons and lymphokines. Useful compositions are also provided by this invention.

Abstract: The use of poly(lactide) or poly(lactide-co-glycolide) microparticles with adsorbed antigen is disclosed. The microparticles are useful for enhancing CTL responses to a selected antigen.

Abstract: The invention proyides novel compositions comprising imidazoquinoxaline compounds of formula (I) and analogs thereof. Also provided are methods of administering the compositions in an effective amount to enhance the immune response of a subject. Further provided are novel compositions and methods of administering the compositions in combination with (an) other agent (s).

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: This invention provides novel processes for therapeutic applications, including the treatment of subjects carrying infectious agents or having impaired autoimmunity or impaired immune condition. The therapeutic applications disclosed herein are also directed at the treatment of cancerous subjects with malignant tumors containing cancerous cells or malignant or cancerous cells. Vaccination processes for preventing infections in subjects are also provided. The novel processes comprise introducing into or administering to a subject one or more antigens, or trained or adopted immune cells. These antigens or immune cells are capable of establishing or increasing at least one first specific immune response and decreasing at least one second specific immune response. Such responses include components, such as cellular immune reaction elements, humoral immune reaction elements and cytokines, the latter also encompassing interferons and lymphokines. Useful compositions are also provided by this invention.

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 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: A composition for treating or preventing virus-induced infections is described, along with a process of producing the composition and methods of the composition's use. The composition comprises viral pathogen-infected cell or tissue, or malignantly or immunologically aberrant cells or tissues which has been reduced and/or denatured. The preferred composition is administered across a mucosal surface of an animal suffering or about suffer from infection. The composition is administered as preventive or therapeutic vaccine.

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: Inclusion of fatty adjuvants in vaccine compositions can cause difficulties with certain antigenic components, particularly with antigens that include a surfactant component. A method for preparing an immunogenic composition comprising an antigen and a fatty adjuvant involves purification of the antigen substantially in the absence of surfactant. Where surfactants cannot be avoided, the following are combined: (i) an antigen component that includes a surfactant and (ii) a fatty adjuvant component, to give a composition in which the weight ratio of said fatty adjuvant to said surfactant is less than 1000:1.

Abstract: An immunogenic composition comprising: (i) an antigen; (ii) an aluminum phosphate adjuvant; and (iii) a 3-O-deacylated monophosphoryl lipid A adjuvant. Components (ii) and (iii) can also be used as a separate adjuvant system. Various features of the compositions are disclosed, including that at least 50% of the 3-O-deacylated monophosphoryl lipid A adjuvant should be adsorbed to the aluminum phosphate adjuvant. The adjuvant mixture is particularly useful with hepatitis B virus surface antigen.

Abstract: Aspects of the present invention relate to chimeric polypeptides including HCV NS3/4A sequences and T-cell epitopes. Embodiments include nucleic acids encoding the chimeric NS3/4A polypeptides, the encoded polypeptides, compositions containing said nucleic acids, compositions containing said chimeric polypeptides, as well as methods of making and using the aforementioned compositions including, but not limited to medicaments and vaccines.

Abstract: Biological materials such as vaccines can be stabilised in certain glassy materials, soluble in water. It has been proposed to form these glassy materials as a powder suspended in a non-aqueous liquid for injection into a patient. There is a problem in maintaining the suspension because the particles tend to sink to the bottom. The problem is solved by adding a blowing agent into a solution for which the glass is formed. The blowing agent decomposes as the solution evaporates thereby forming cavities in the resulting glass structure, reducing its density to match that of the liquid in which it is to be suspended. Other uses for the invention are in compositions intended for inhalation and for rapid dissolution in aqueous solutions immediately before use.

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 administering the plant material containing the NEPA in conjunction with a suitable adjuvant. 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. HBsAg in the plant results from expression by the plant of the NEPA due to genetic alteration.

Abstract: Reagents, methods and immunodiagnostic test kits for the accurate detection of hepatitis B virus (HBV) infection are disclosed. The methods and kits employ novel rabbit monoclonal antibodies directed against HBV surface antigens (HBsAg) with mutations in the “a” determinant region of HBsAg.

Abstract: HBsAg is expressed in a Saccharomyces cerevisiae host, carrying a plasmid having a HBsAg coding sequence, wherein the plasmid includes: (1) an upstream promoter from a glyceraldehyde-3-phosphate dehydrogenase gene, for controlling expression of the HBsAg coding sequence; and (2) an ARG3 transcription terminator downstream of the HBsAg coding sequence. The plasmids may also include: (3) a LEU2 selection marker; (4) a 2? plasmid sequence; and (5) an origin of replication functional in Escherichia coli. HBsAg can be expressed in this host, and can be purified for use in the manufacture of vaccines, and in particular for the manufacture of combination vaccines and in new monovalent HBV vaccines e.g. with non-alum adjuvants.

Abstract: The subject invention relates to a novel hepatitis B surface antigen mutant and methods of detecting this mutant, and/or antibodies thereto, in patient samples. In particular, the mutant contains a substitution of amino acid threonine for the amino acid alanine at position 123 in the amino acid sequence of the hepatitis B surface antigen (HBsAg) protein.

Abstract: Immunogenic compositions are described herein which comprise microparticles that further comprise a biodegradable polymer. The microparticle compositions also comprise a cationic polysaccharide and an immunological species selected from an antigen, an immunological adjuvant and a combination thereof. Also described are methods of making such compositions and methods of administering such compositions. Methods of modulating the release rate of immunological species from microparticles are also described. These methods comprise varying the ratio of the cationic polysaccharide relative to the biodegradable polymer within the microparticles.

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: The present invention provides methods for the control of the generation of regulatory T cells (Tregs) and uses thereof.

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 provides an adjuvant, which includes at least one single strand deoxynucleotide containing a CpG dinucleotide. The single strand deoxynucleotide comprises one or more CpG dinucleotides. When used in combination with rabies vaccine, HBV vaccine or other vaccines, the adjuvant can significantly improve the immune effect of the vaccine.

Abstract: The present invention relates generally to viral variants exhibiting reduced sensitivity to particular agents and/or reduced interactivity with immunological reagents. More particularly, the present invention is directed to hepatitis B virus (HBV) variants exhibiting complete or partial resistance to nucleoside or nucleotide analogs and/or reduced interactivity with antibodies to viral surface components including reduced sensitivity to these antibodies. The present invention further contemplates assays for detecting such viral variants, which assays are useful in monitoring anti-viral therapeutic regimens and in developing new or modified vaccines directed against viral agents and in particular HBV variants. The present invention also contemplates the use of the viral variants to screen for and/or develop or design agents capable of inhibiting infection, replication and/or release of the virus.

Abstract: The present invention relates to a method for the production of a hepatitis B antigen suitable for use in a vaccine, the method comprising purification of the antigen in the presence of cysteine, to vaccines comprising such antigens.

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: A method for obtaining an immune response to hepatitis B surface antigen (HBsAg) by feeding the antigen in a plant material to an animal that is immunoreceptive to the HBsAg. It has now been discovered that the animal may be made immunoreceptive to HBsAg either by administering the plant material containing HBsAg in conjunction with a suitable adjuvant or by prior primary immunization. When the animal is made immunoreceptive by a prior, e.g. primary, immunization, an immune response to HBsAg may be boosted in the animal by feeding the animal the plant material containing the HBsAg. 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 hepatitis B surface antigen (HBsAg).

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: The present invention is concerned with vaccines and their preparation. An effective long-term immune response, especially in mammals, can be produced using a vaccine comprising an antigen encapsulated in liposomes, a suitable adjuvant and a carrier comprising a continuous phase of a hydrophobic substance. The vaccine is particularly effective in eliciting the production of antibodies that recognize epitopes of native proteins.

Abstract: The invention provides in part methods of treating cancers of a specific organ or tissue by administering a composition that is antigenically specific for one or more microbes that are pathogenic in the specific organ or tissue in which the cancer is situated. The formulations of the invention thereby facilitate activation of a treatment response to a cancer in a particular tissue or organ. The compositions may for example include killed or attenuated microbial pathogens, and may be administered at sites distant from the cancer, for example the skin. In some embodiments, microbial species of endogenous flora that are known to cause infection in the relevant organ or tissue may be used in the formulation of the antigenic compositions. In alternative embodiments, exogenous microbial pathogens that are known to cause infection in the relevant organ or tissue may be used in the formulation of the antigenic 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 anti-viral vaccine of the present invention is produced in transgenic plants and then administered through standard vaccine introduction method or through the consumption of the edible portion of those plants. A DNA sequence encoding for the expression of a surface antigen of a viral pathogen is isolated and ligated to a promoter which can regulate the production of the surface antigen in a transgenic plant. This gene is then transferred to plant cells using a procedure that results in its integration into the plant genome, such as through the use of an Agrobacterium tumenfaciens plasmid vector system. Preferably, the foreign gene is expressed in an portion of the plant that is edible by humans or animals. In a preferred procedure, the vaccine is administered through the consumption of the edible plant as food, preferably in the form of a fruit or vegetable juice which can be taken orally.

Abstract: The present invention relates generally to viral variants exhibiting reduced sensitivity to particular agents and/or reduced interactivity with immunological reagents. More particularly, the present invention is directed to hepatitis B virus (HBV) variants exhibiting complete or partial resistance to nucleoside or nucleotide analogs and/or reduced interactivity with antibodies to viral surface components including reduced sensitivity to these antibodies. The present invention further contemplates assays for detecting such viral variants, which assays are useful in monitoring anti-viral therapeutic regimens and in developing new or modified vaccines directed against viral agents and in particular HBV variants. The present invention also contemplates the use of the viral variants to screen for and/or develop or design agents capable of inhibiting infection, replication and/or release of the virus.

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

Abstract: The invention relates to sequences of a novel variant of the Hepatitis B surface antigen (HBsAg) and to methods for detecting, in patient samples, nucleic acids, antigens and antibodies directed against the same.

Abstract: The invention concerns mixed micelles or micro-aggregates for inducing an immune response containing at least a first lipopeptide comprising a CTL epitope and at least a first lipid motif; and a second lipopeptide comprising at least an auxiliary T epitope and at least a lipid motif, whereof the type can be different from the first lipopeptide motif. Said micelles can be used as medicines and vaccines.

Abstract: The subject invention provides a disease-treating drug that uses hollow protein nanoparticles to specifically act on a target cell or tissue. The present invention allows a protein drug to be effectively capsulated in the particles. The invention also provides a therapeutic method using such a drug. The drug according to the present invention is capable of recognizing a specific cell, such as hepatocytes, and manufactured by fusing a disease-treating substance for a target cell (for example, interferon, hepatocyte growth factor etc.) with hollow nanoparticles of a particle-forming protein (for example, hepatitis B virus surface-antigen protein).

Abstract: The invention provides for a method of enhancing immunological responses to an antigen in a vaccine formulation, and for a vaccine formulation that provides for an enhanced immunological response to an antigen. In the method and formulation the antigen is administered with an adjuvant which adjuvant comprises a solution of nitrous oxide gas in a pharmaceutically acceptable carrier solvent for the gas and which adjuvant includes at least one fatty acid or ester or other suitable derivative thereof selected from the group consisting of oleic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, arachidonic acid, eicosapentaenoic acid [C20: 5?3], decosahexaenoic acid [C22: 6?3], ricinoleic acid and derivatives thereof selected from the group consisting of the C1 to C6 alkyl esters thereof, the glycerol-polyethylene glycol esters thereof and the reaction product of hydrogenated natural oils composed largely of ricinoleic acid based oils, such as castor oil with ethylene oxide.

Abstract: The present invention relates to adjuvant compositions which are suitable to be used in vaccines. In particular, the adjuvant compositions of the present invention comprises a saponin and an immunostimulatory oligonucleotide, optionally with a carrier. Also provided by the present invention are vaccines comprising the adjuvants of the present invention and an antigen. Further provided are methods of manufacture of the adjuvants and vaccines of the present invention and their use as medicaments. Methods of treating an individual susceptible to or suffering from a disease by the administration of the vaccines of the present invention are also provided.

Abstract: The present invention encompasses lipid nano/micro particles, which have been modified, preferably on their surface, to contain a molecule or ligand, which targets the nano/micro particles to a specific site. The invention also encompasses the use of the modified lipid nano/micro particles for the oral delivery of drugs and antigen delivery systems.

Abstract: Cationic liposomes with entrapped polynucleotide in the intravesicular space are described. The liposomes include cationic components such as cationic lipids such as DOTAP. Preferably the method of forming liposomes uses the dehydration-rehydration method in the presence of the polynucleotide. The polynucleotide preferably operatively encodes an antigen capable of eliciting a desired immune response, that is, is a gene vaccine.

Abstract: The present invention is directed to a method of inducing an immune response against a hepatitis B antigen (e.g., an antigen from a hepatitis B virus) in a mammal, which comprises administering to the mammal a priming composition (e.g., a DNA plasmid), comprising a source of one or more epitopes of the hepatitis B target antigen; and a boosting composition, comprising a source of one or more eptiopes of the hepatitis B target antigen (e.g., a non-replication or replication-impaired poxvirus such as MVA), wherein at least one epitope of the boosting composition is identical to an epitope of the priming composition. The present invention also is directed to a method of inducing an immune response against a hepatitis B antigen (e.g., an antigen from a hepatitis B virus) in a mammal, which comprises administering to the mammal a priming composition (e.g., a DNA plasmid), comprising a source of one or more epitopes of the hepatitis B target antigen.

Abstract: The present invention relates generally to viral variants exhibiting reduced sensitivity to agents and in particular nucleoside analogues. More particularly, the present invention is directed to hepatitis B virus variants exhibiting complete or partial resistance to nucleoside analogues. The variants may also comprise corresponding mutations affecting immunological interactivity to viral surface components. The present invention further contemplates assays for detecting such viral variants which assays are useful in monitoring anti-viral therapeutic regimes and in developing new or modified vaccines directed against viral agents and in particular hepatitis B virus variants. The present invention also contemplates the use of the viral variants to screen for agents capable of inhibiting infection, replication and/or release of the virus.

Abstract: The present invention is directed to methods for preparing a stable powder formulation of an alum-adsorbed vaccine. The methods comprise atomizing a liquid formulation comprising an immunogen adsorbed onto an aluminum adjuvant to produce an atomized formulation, freezing the atomized formulation to produce frozen particles, and drying the frozen particles to produce dried powder particles. Pharmaceutical compositions comprising a stable powder formulation of an alum-adsorbed vaccine are also disclosed herein. The pharmaceutical compositions are stable at high temperatures and can be reconstituted in a pharmaceutically acceptable carrier to produce a reconstituted liquid vaccine that exhibits little or no particle agglomeration and retains immunogenicity. Methods of using the alum-adsorbed vaccine compositions for preventing and treating a disease in a subject, wherein the disease is associated with the particular immunogen, are further provided.

Abstract: The present invention relates generally to the field of Hepatitis B variants exhibiting a reduced sensitivity to nucleoside analogues, both in vivo and in vitro. More in particular, reverse transcriptase mutant rtA181S is provided. Present invention provides assays and methods for detecting such variant, which assays are useful in monitoring anti-viral therapeutic regimes and adjusting patient therapy. A diagnostic kit for detecting the presence of an HBV variant in a biological sample has also been described.

Abstract: The invention provides compositions and methods for treating or preventing a target disease in a mammal by induction of memory T cells. The methods comprise (1) administering a sensitizing composition comprising a non-target antigen to a patient; and (2) administering a therapeutic composition comprising a non-target antigen and a target antigen to the patient, wherein the target antigen is associated with the disease, and wherein the therapeutic composition is administered after the sensitizing compositions, at an interval sufficient for induction of memory T cells. The methods can alternatively comprise administering a target antigen along with an inhibitory agent such as an inhibitor of DC apoptosis, an inhibitor of granzyme B, a Granzyme-B-inducible mediator of apoptosis, an inhibitor of perforin, or a perforin-inducible mediator of apoptosis.

Abstract: A method of cancer screening comprising the steps of administering the Blood CA 27,29 testing procedure; if the result is positive administering a mammogram; if the result is positive administering a needle biopsy; if the result is positive administering a PET scan; if the result is positive administering a blood tumor cell count. If all of the foregoing steps are positive, the cancer is treated by selecting one or more treatments from a group of provided treatment according to the patient's body and condition. A method of treating auto-immune diseases comprises selecting one or more treatments from another group of provided treatments, the one or more treatments selected and administered according to the patient's body and condition.

Abstract: A method for enhancing the immune response to an antigen or vaccine comprising administering an effective amount of a Th1 stimulatory cytokine, preferably interferon, oromucosally at substantially the same time as administration of an effective amount of an antigen or vaccine.