Abstract: This invention relates to cholesterol-sequestering agents and methods of using cholesterol-sequestering agents to treat or prevent infection. The compositions of the invention can be used in vitro or in vivo to decrease the load of a microorganism in a biological sample. Methods of generating an immune response against a microorganism are also included.

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: The present invention relates to a novel isolated avian hepatitis E virus having a nucleotide sequence set forth in SEQ ID NO:1 or its complementary strand. The invention further concerns immunogenic compositions comprising this new virus or recombinant products such as the nucleic acid and vaccines that protect an avian or mammalian species from viral infection or hepatitis-splenomegaly syndrome caused by the hepatitis E virus. Also included in the scope of the invention is a method for propagating, inactivating or attenuating a hepatitis E virus comprising inoculating an embryonated chicken egg with a live, pathogenic hepatitis E virus and recovering the virus or serially passing the pathogenic virus through additional embryonated chicken eggs until the virus is rendered inactivated or attenuated.

Abstract: The present invention provides a combined vaccine that includes hepatitis B vaccine (HeVac) and Bacille Calmette-Guerin (BCG) for intracutaneous injection and the method of preparation of such vaccine. The combined vaccine changes the now used liquid agent of the HeVac into a cryoprotectant, thus improving the heat stability of the HBsAg. Because of the cryoprotectant in the combined vaccine, the heat stability of the HBsAg is improved, and the efficacy of the vaccine is only slightly decreased after 30 days at 37° C., and the decrease is lower than with the liquid agent of the HeVac. The present invention changes the newborn's inoculation from two injections into one to simultaneously obtain prophylaxis of hepatitis B and tuberculosis.

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: The present invention provides a pharmaceutical composition with an adjuvant based on an apathogenic virus, together with an antigen. The adjuvant has a natural or through genetical engineering no, reduced or altered expression of an endogenous interferon antagonist or endogenous immune suppressor.

Abstract: The present invention provides a cell line capable producing infectious hepatitis C virus 1a (HCV 1a) particles in culture. Disclosed are compositions and methods for an HCV 1a (clone H77) transfected immortal human hepatocyte (IHH) capable of generating infectious HCV 1a virus particles in culture. Also disclosed are methods of using the cell line, or HCV 1a virus particles derived from said cell line, to screen for potential therapeutic agents which interfere with HCV 1a virus propagation to treat hepatic disease.

Abstract: A biodegradable and thermosensitive poly(organophosphazene) with a functional group, a preparation method thereof, and a use thereof for delivery of bioactive substances are provided.

Abstract: This invention provides a dry powder composition for poultry vaccination via inhalation comprising an effective amount of a poultry vaccine agent, and a supporting amount of carriers for said poultry vaccine agent, said carriers comprising a combination of a reducing or non-reducing sugar and a biocompatible polymer, said dry powder composition being in the form of particles having an average particle size from 2 to 30 ?m and a particle size polydispersity from 1.1 to 4.0. This invention also relates to a method for producing said dry powder compositions and a system for vaccination of poultry by inhalation.

Abstract: The present invention relates to a biodegradable and thermosensitive poly(organophosphazene) with a functional group, a preparation method thereof, and a use thereof for delivery of bioactive substances. According to the present invention, poly(organophosphazene) is a phosphagen-based polymer showing biodegradability, thermosensitivity, and sol-gel phase transition depending on temperature change, whereby when administered into a living body with bioactive substances such as drugs, the poly(organophosphazene) forms a gel-phase at body temperature to be capable of controlled release of the bioactive substances. Further, the poly(organophosphazene) has functional groups to chemically bind with bioactive substances through an ionic bond, covalent bond, or coordinate covalent bond to be capable of a sustained release of the bioactive substances due to its good binding property. Therefore, the poly(organophosphazene) is useful as a delivery material for bioactive substances.

Abstract: The present invention relates to a method for reducing the occurrence and severity of infectious diseases, especially infectious diseases in which lipid-containing infectious viral organisms are found in biological fluids, such as blood. The present invention employs solvents useful for extracting lipids from the lipid-containing infectious viral organism thereby creating modified viral particles with reduced infectivity and enhanced antigenicity. The present invention provides vaccine compositions, comprising these modified viral particles with reduced infectivity and enhanced antigenicity, optionally combined with a pharmaceutically acceptable carrier or an immunostimulant. The vaccine composition is administered to a patient to provide protection against the lipid-containing infectious viral organism. The vaccine compositions of the present invention include combination vaccines of modified viral particles obtained from one or more strains of a virus and/or one or more types of virus.

Abstract: The present invention relates to the use of erythropoietin (EPO) for enhancing immune responses and for the treatment of lymphoproliferative disorders, excluding multiple myeloma. Accordingly to the invention EPO may be administered with a viral or bacterial vaccine.

Abstract: Described is a method for isolating Hepatitis C Virus peptides (HPs) which have a binding capacity to a MHC/HLA molecule or a complex comprising said HCV-peptide and said MHC/HLA molecule characterized by the following steps: —providing a pool of HCV-peptide, said pool containing HCV-peptides which bind to said MHC/HLA molecule and HCV-peptides which do not bind to said MHC/HLA molecule, —contacting said MHC/HLA molecule with said pool of HCV-peptides whereby a HCV-peptide which has a binding capacity to said MHC/HLA molecule binds to said MHC/HLA molecule and a complex comprising said HCV-peptide and said MHC/HLA molecule is formed, —detecting and optionally separating said complex from the HCV-peptide which do not bind to said MHC/HLA molecule and optionally isolating and characterizing the HCV-peptide from said complex.

Abstract: The present invention relates to nanoparticle vaccines comprised of a carrier, particularly polymerized lipids, having multiple copies of an antigen or combinations of different antigens displayed on the carrier. Such antigen-displaying nanoparticles may also display a targeting molecule on its surface in order to direct it to a specific site or cell type to optimize a desired immune response. The present invention also relates to encapsulating an antigen or combinations of different antigens within such nanoparticles, with or without a targeting molecule displayed on its surface. The antigens used in this invention are effective to produce an immune response against a variety of pathological conditions.

Abstract: Fusion proteins comprising an immunogenic polypeptide are disclosed. The immunogenic polypeptide consists of the amino acid sequence motif Xaa-Thr-Xaa-Val-Thr-Gly-Gly-Xaa-Ala-Ala-Arg-Thr-Thr-Xaa-Gly-Xaa-Xaa-Ser-Leu-Phe-Xaa-Xaa-Gly-Xaa-Ser-Gln-Xaa-Ile-Gln-Leu-Ile (SEQ ID NO:8). Also disclosed are immunogenic compositions comprising a pharmaceutically acceptable carrier and the fusion protein.

Abstract: Compositions and methods for enhancing the effect of vaccines in animals, such as domestic, sport, or pet species, and humans are disclosed. More particularly, vaccine compositions comprising ribavirin and an antigen, preferably an antigen that has an epitope present in Hepatitis C virus (HCV), are disclosed for use in treating and preventing disease, preferably HCV infection.

Abstract: The present invention relates to compositions and methods for enhancing the effect of vaccines in animals, such as domestic, sport, or pet species, and humans. More particularly, the use of Ribavirin as an adjuvant to a vaccine protocol and compositions having Ribavirin and an antigen are described.

Abstract: The therapeutic agent for hepatitis, containing alanine and glycine, has only a slight toxicity and it can be administered either orally or intravenously to improve the liver function.

Abstract: A highly immunoreactive viral peptide, pE2, is disclosed which is derived from the carboxy-terminal end region of ORF2 region of the hepatitis E virus (HEV) genome. A unique feature of the novel pE2 peptide is that it possesses conformational antigenic determinants which are only exposed when monomers of the peptide associate with one another through non-covalent interactions to naturally form homodimers. The novel pE2 peptide is proven to be highly reactive with sera from patients having current or past infection with HEV which suggests that the homodimer may mimic certain structural features of the HEV capsid protein. Furthermore, the antigenic activity of the pE2 peptide is strictly conformational in nature and therefore, exhibits immunochemical reactivity only when the peptide exists in a dimeric form. Consequently, the antigenic activity is lost upon dissociation of the dimers, but the activity is restored when the monomers reassociate to form dimers.

Abstract: The invention describes the identification of a major neutralization site of hepatitis E virus (HEV) and the use of this neutralization site in methods of vaccination and in methods of screening for neutralizing antibodies to HEV. The invention also describes the isolation and characterization of neutralizing chimpanzee monoclonal antibodies reactive to the neutralization site and the use of these antibodies in the diagnosis, treatment and prevention of HEV.

Abstract: The present invention provides a vaccine accelerator factor (VAF) which is an in ovo nucleotide immuno-stimulant. The VAF contains one or more DNA constructs, each having a DNA molecule and a vector. Each of the DNA molecule contains one or more genes or gene fragments, each encoding an antigenic peptide of an avian virus. The VAF is preferably administered to the amniotic fluid of an egg after being fertilized for about 17–19 days. The VAF can be co-administered with a viral vaccine containing one or more attenuated or inactive avian viruses. Alternatively, the VAF can be administered prior to the administration of the viral vaccine, which is administered at hatch or post-hatch. The VAF stimulates and accelerate a protective immune response of a viral vaccine.

Abstract: The present invention provides vaccine compositions comprising an oil-in-water emulsion optionally with 3 De-O-acylated monophosphoryl lipid A and QS21. The vaccine compositions are potent induces of a range of immune responses.

Abstract: The present invention relates to a novel isolated avian hepatitis E virus having a nucleotide sequence set forth in SEQ ID NO:1 or its complementary strand. The invention further concerns immunogenic compositions comprising this new virus or recombinant products such as the nucleic acid and vaccines that protect an avian or mammalian species from viral infection or hepatitis-splenomegaly syndrome caused by the hepatitis E virus. Also included in the scope of the invention is a method for propagating, inactivating or attenuating a hepatitis E virus comprising inoculating an embryonated chicken egg with a live, pathogenic hepatitis E virus and recovering the virus or serially passing the pathogenic virus through additional embryonated chicken eggs until the virus is rendered inactivated or attenuated.

Abstract: Novel combined vaccine composition preferentially for administration to adolescents are provided, comprising a hepatitis B viral antigen and a herpes simplex viral antigen and optionally in addition one or more of the following: an EBV antigen, a hepatitis A antigen or inactivated attenuated virus, an HPV antigen, a V2V antigen, a HCMV antigen, a Toxoplasma gondii antigen. The vaccine compositions are formulated with an adjuvant which is a preferential stimulator of TH1 cell response such as 3D-MPL and QS21.

Abstract: A vaccine formulation for the treatment or prophylaxis of hepatitis, especially hepatitis, especially hepatitis B, infections is provided comprising the hepatitis antigen and a suitable carrier such as alum in combination with 3-O-deacylated monophosphoryl lipid. A combination vaccines including the vaccine formulation are also described.

Abstract: A vaccine having a good vaccination effect, which comprises an antigen; a peptide selected from the group consisting of a peptide having the amino acid sequence of SEQ ID NO: 1, a peptide having the amino acid sequence of SEQ ID NO: 2, and a peptide derived from a peptide having the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2; and an immune activator.

Abstract: Newly elucidated sequences of hepatitis C virus type 4 and type 5 are described, together with those of a newly discovered type 6. Unique type-specific sequences in the NS4, NS5 and core regions enable HCV detection and genotyping into types 1 to 6. Antigenic peptides and immunoassays are described.

Abstract: Recombinant hepatitis C virus (HCV) capsid proteins that self-assemble into large spherical virus-like particles structures and viral capsids that include conformational antigenic epitopes are provided. The large spherical virus-like particles structures and viral capsids, including capsid proteins that are expression products of a viral particle coding sequence protein, may be prepared as vaccines to induce a cellular or humoral immune response. The self assembling capsid proteins may also be used as elements of diagnostic immunoassay procedures for HCV infection.

Abstract: A nucleic acid having a first nucleotide sequence encoding an infectious hepatitis C virus, a second nucleotide sequence encoding a ribozyme, and an inducible promoter operably linked to the first and second nucleotide sequences, the ribozyme being configured to remove a 3′ sequence unnecessary for replication of the infectious hepatitis C virus from a transcript initiated by the inducible, is described. A cell containing the nucleic acid and methods of using the cell are also described.

Abstract: The present invention relates to a method for reducing the occurrence and severity of infectious diseases, especially infectious diseases in which lipid-containing infectious organisms are found in biological fluids, such as blood. The present invention employs solvents useful for extracting lipids from the lipid-containing infectious organism, thereby reducing the infectivity of the infectious organism. The present invention uses optimal solvent systems such that the lipid envelope around the viral particle is dissolved while the viral particle remains intact, resulting in a modified viral particle. The present invention also provides an autologous vaccine composition, comprising a lipid-containing infectious organism, treated with solvents to reduce the lipid content of the infectious organism, combined with a pharmaceutically acceptable carrier. The vaccine composition is administered to an animal or a human to provide protection against the lipid-containing infectious organism.

Abstract: Disclosed are methods of stimulating in a subject an immune response to an antigen to which the immune response is targeted. This method includes the step of administering to the subject a binding agent which binds a surface receptor of an antigen-presenting cell, in some instances without being blocked substantially by the natural ligand for the surface receptor, and an antigen to which the immune response is targeted, in a physiologically acceptable medium to the subject. Also disclosed are molecular complexes including the binding agent coupled to an antigen.

Abstract: In a method of treating viral infections and of tumors induced thereby a radioimmunoconjugate (RIC) containing an immunologically effective component and a radioactive component is provided. The immunologically effective component contains a) a receptor molecule or a fragment thereof having affinity to an epitope of the viral structural proteins expressed on the plasma membrane of infected cells, or b) a fragment of the cellular receptor molecule modified by mutagenesis, the fragment having affinity to an epitope of the viral structural proteins expressed on the plasma membrane of infected cells. The radioactive component is an alpha emitter or a beta emitter. The therapeutical agent is effective against viral infections such as HIV, HBV, HCV, HDV, HTLV, CMV, EBV, or HHV8 infections.

Abstract: The present invention relates to a composition, which includes a hepatitis B surface antigen stabilized with a milk protein and/or a milk protein component. This composition can be used in an oral vaccine for treatment of hepatitis B. The present invention further relates to methods of immunizing a subject against hepatitis, methods of administrating the composition of the present invention, and methods of producing a stabilized hepatitis B surface antigen protein.

Abstract: A strain of hepatitis E virus from Pakistan (SAR-55) implicated in an epidemic of enterically transmitted non-A, non-B hepatitis, now called hepatitis E, is disclosed. The invention relates to the expression of the whole structural region of SAR-55, designated open reading frame 2 (ORF-2), in a eukaryotic expression system. The expressed protein is capable of forming HEV virus-like particles which can serve as an antigen in diagnostic immunoassays and as an immunogen or vaccine to protect against infection by hepatitis E.

Abstract: The present invention relates to compositions and methods for enhancing the effect of vaccines in animals, such as domestic, sport, or pet species, and humans. More particularly, the use of Ribavirin as an adjuvant to a vaccine protocol and compositions having Ribavirin and an antigen are described.

Abstract: An isolated nucleic acid, a recombinant protein encoded thereby and uses thereof. The isolated nucleic acid including (a) a polynucleotide at least 60% identical to SEQ ID NOs:1, 3, 5 or portions thereof as determined using the Bestfit procedure of the DNA sequence analysis software package developed by the Genetic Computer Group (GCG) at the university of Wisconsin (gap creation penalty—50, gap extension penalty—3); (b) a polynucleotide encoding a polypeptide being at least 60% homologous with SEQ ID NOs:2, 4, 6 or portions thereof as determined using the Bestfit procedure of the DNA sequence analysis software package developed by the Genetic Computer Group (GCG) at the university of Wisconsin (gap creation penalty—50, gap extension penalty—3); or (c) a polynucleotide hybridizable with SEQ ID NOs:1, 3, 5 or portions thereof at 68° C. in 6×SSC, 1% SDS, 5× Denharts, 10% dextran sulfate, 100 &mgr;g/ml salmon sperm DNA, and 32p labeled probe and wash at 68° C.

Abstract: The present invention provides vaccine compositions comprising an oil-in-water emulsion optionally with 3 De-O-acylated monophosphoryl lipid A and QS21. The vaccine compositions are potent inducers of a range of immune responses.

Abstract: A chimeric, carboxy-terminal truncated hepatitis B virus nucleocapsid protein (HBc) is disclosed that contains an immunogen for inducing the production of antibodies to the influenza M2 protein. An immunogenic influenza epitope is preferably expressed at or near the N-terminus or in the HBc immunogenic loop sequence. The chimer preferably contains an influenza-specific T cell epitope and is preferably engineered for both enhanced stability of self-assembled particles and enhanced yield of those chimeric particles. Methods of making and using the chimers are also disclosed.

Abstract: Particles, useful as a delivery system for an epitope, are composed of a chimaeric hepadnavirus core antigen protein wherein a foreign amino acid sequence comprising an epitope is inserted in or replaces all or part of the sequence of amino acid residues from 68 to 90 in the case where the core antigen is hepatitis B core antigen or the corresponding amino acid sequence in the case of the core antigen of another hepadnavirus.

Abstract: The invention provides a method of activating hepatitis C virus (HCV)-specific T cells, including CD4+ and CD8+ T cells. HCV-specific T cells are activated using fusion proteins comprising HCV NS3, NS4, NS5a, and NS5b polypeptides, polynucleotides encoding such fusion proteins, or polypeptide or polynucleotide compositions containing the individual components of these fusions. The method can be used in model systems to develop HCV-specific immunogenic compositions, as well as to immunize a mammal against HCV.

Abstract: Adjuvant compositions comprising type 1 interferon inducers, such as double-stranded RNA, in combination with antigen delivery systems and/or immunostimulatory molecules, such as immunostimulatory nucleic acid sequences, for enhancing the immune response of a coadministered antigen, are described.

Abstract: The invention relates to a new virus, designated H101.c33 or Sentinel Virus II (SVII). Isolated SVII viruses, polynucleotides and proteins from SVII viruses, and antibodies which bind SVII virus and SVII viral proteins are provided. The polynucleotides, proteins, and antibodies of the invention may be used to detect SVII virus or infection by SVII virus in a susceptible individual. Additionally, polynucleotides of the invention may be inserted into recombinant expression vectors for recombinant production of viral proteins.

Abstract: The present invention provides a substance which inhibits the binding between E2/NS1 protein of hepatitis C virus and a cell infectious with hepatitis C virus, a cell expressing CD81, or CD81. The present invention can provide a novel medicament which has an anti-viral effects such as an inhibitory action against HCV infection.

Abstract: The present invention relates to genomic nucleotide sequences and amino acid sequences corresponding to the non-coding and coding region of a new type of HCV. The invention relates to new HCV types and subtypes sequences which are different from the known HCV types and subtypes sequences. Particularly, the present invention relates to said new HCV type sequences; a process for preparing them, and their use for diagnosis, prophylaxis and therapy. More particularly, the present invention provides new type-specific sequences of the 5′ NCR, Core, the E1 and the NS5 regions of the new HCV type. These new HCV sequences are useful to diagnose the presence of HCV type genotypes or serotypes in a biological sample. Moreover, the availability of these new type-specific sequences can increase the overall sensitivity of HCV detection and should also prove to be useful for prophylactic and therapeutic purposes.

Abstract: Monoclonal antibodies that specifically bind to HCV core antigen. Also provided are hybridoma cell lines which secrete these antibodies, methods for making and using these antibodies, including kits that include these antibodies.

Abstract: A unique HCV RNA molecule is provided having an enhanced efficiency of establishing cell culture replication. Novel adaptive mutations have been identified within the HCV non-structural region that improves the efficiency of establishing persistently replicating HCV RNA in cell culture. This self-replicating polynucleotide molecule contains, contrary to all previous reports, a 5′-NTR that can be either an A as an alternative to the G already disclosed and therefore provides an alternative to existing systems comprising a self-replicating HCV RNA molecule. The G->A mutation gives rise to HCV RNA molecules that, in conjunction with mutations in the HCV non-structural region, such as the G(2042)C/R mutations, possess greater efficiency of transduction and/or replication. These RNA molecules when transfected in a cell line are useful for evaluating potential inhibitors of HCV replication.

Abstract: The present invention relates to a method for purifying recombinant HCV single or specific oligomeric envelope proteins selected from the group consisting of E1 and/or E2 and/or E1/E2, characterized in that upon lysing the transformed host cells to isolate the recombinantly expressed protein a disulphide bond cleavage or reduction step is carried out with a disulphide bond cleavage agent. The present invention also relates to a composition isolated by such a method. The present invention also relates to the diagnostic and therapeutic application of these compositions.

Abstract: HCV E1E2 compositions comprising E1E2 antigens, submicron oil-in-water emulsions and/or immunostimulatory nucleic acid sequences are described. The compositions can be used in methods of stimulating an immune response in a vertebrate subject.