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: 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: A vaccine composition comprising two valences is provided: (i) a first valence which is adjuvant-enhanced with aluminum hydroxide and (ii) a second valence which contains a polysaccharide of bacterial capsule comprising one or more o-acetyl groups and which is not adsorbed with aluminum oxide due to the presence of a protecting compound which may be a phosphate, a citrate or a carbonate and which prevents the adsorption. The first valence can be any vaccine valence. In one particular embodiment, the vaccine composition contains (i) Hepatitis A valence, adsorbed on aluminum hydroxide and (ii) the typhoid fever valence formed by the polysaccharide Vi of the Salmonella typhi capsule.

Abstract: Described is a method for making a pharmaceutical preparation comprising the solubilisation of a peptide mixture, characterized in that the peptide mixture is solubilized by an aqueous solution containing at least one organic acid selected from the group consisting of formic acid, acetic acid, propionic acid, butyric acid and halogenated or hydroxylated forms thereof.

Abstract: The present invention provides vaccine and adjuvant formulation comprising an immunostimulant and a metal salt. The immunostimulant is adsorbed onto a particle of metal salt and the resulting particle is essentially devoid of antigen.

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: 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: A pure, water-soluble polypeptide containing one or more monomers of a VP1 protein of a foot-and-mouth disease virus; or a pure, water-insoluble polypeptide comprising two or more monomers of a VP1 protein of a foot-and-mouth disease virus. Also disclosed are a vaccine containing the polypeptide, a method of producing the polypeptide, and a method of inducing an immune response in a subject by administering to the subject an effective amount of the polypeptide.

Abstract: Compositions and methods for the therapy and diagnosis of cancer, such as prostate cancer, are disclosed. Compositions may comprise one or more prostate-specific proteins, immunogenic portions thereof, or polynucleotides that encode such portions. Alternatively, a therapeutic composition may comprise an antigen presenting cell that expresses a prostate-specific protein, or a T cell that is specific for cells expressing such a protein. Such compositions may be used, for example, for the prevention and treatment of diseases such as prostate cancer. Diagnostic methods based on detecting a prostate-specific protein, or mRNA encoding such a protein, in a sample are also provided.

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 provides improved methods of production of viral antigen on a culture of adherent cells bound to a microcarrier, wherein the methods provide for increased viral antigen yield per culture medium volume. The invention is also directed to a cell culture biomass of adherent cells having increased cell density and microcarrier concentration compared to the respective confluent cell culture.

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: The present invention relates to hepatitis A vaccine, especially to a lyophilized attenuated hepatitis A vaccine which can be stored at ambient temperature for extended periods of time, and to a method for producing the same. The present invention further relates to a stabilizer for lyophilized live vaccine and its use in improving thermostability of lyophilized live vaccine during lyophilization processing and storage period after lyophilization.

Abstract: The present invention provides methods of large scale production of Hepatitis A Virus (HAV) on VERO cells bound to microcarrier. The invention also provides for methods of isolation of HAV from the cell culture supernatant of HAV infected VERO cells.

Abstract: The present invention provides methods of purification of Hepatitis A Virus from the supernatant of an infected cell culture and production of a preparation of purified HAV antigen. The present invention is also directed to an HAV vaccine composition comprising a preparation consisting of purified mature HAV particles in an amount sufficient to induce a protective immune response in a mammal.

Abstract: The invention relates to a vaccine formulation for the prevention of Haemophilus Influenzae Type B (Hib) infections and where the antigen is adsorbed onto aluminum phosphate. The invention also relates to a multivalent vaccines, that is a vaccine for the amelioration or treatment of more than one disease states. The present invention also relates to the production and use of such vaccines in medicine.

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 invention provides the use of Hepatitis A virus capsid, or a mucosally immunogenic fragment or epitope thereof, for the manufacture of a mucosal vaccine composition for administration to a mucosal surface of a patient to induce production of serum Immunoglobulin G antibody against Hepatitis A. Preferably the vaccine composition is administered by the intranasal route.

Abstract: The invention relates to methods for regulating hematopoiesis using CpG containing oligonucleotides. In particular, the invention relates to methods of treating thrombopoiesis and anemia by regulating hematopoiesis. The invention also relates to methods of regulating immune system remodeling by administering CpG oligonucleotides to control hematopoiesis.

Abstract: A live hepatitis A virus adapted to growth in MRC-5 cells, which HAV is preferably characterized by suitable attenuation for effective vaccine administration to humans and animals without inactivation, methods for adapting HAV to growth in MRC-5, vaccine compositions and method of vaccinating humans against HAV infection.

Abstract: A vaccine formulation for the treatment or prophylaxis of 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: It is to be understood that the above description is intended to be illustrative and not restrictive. Many embodiments will be apparent to those of skill in the art upon reading the above description. The scope of the invention should, therefore, be determined not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are incorporated herein by reference for all purpose.

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 vaccine formulation for the treatment or prophylaxis of 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: 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 provides methods of purification of Hepatitis A Virus from the supernatant of an infected cell culture and production of a preparation of purified HAV antigen. The present invention is also directed to an HAV vaccine composition comprising a preparation consisting of purified mature HAV particles in an amount sufficient to induce a protective immune response in a mammal.

Abstract: Described are virosomes comprising cationic lipids, biologically active influenza hemagglutinin protein or biologically active derivatives thereof and nucleic acids encoding antigens from pathogenic sources in their insides, preferably antigens from mumps virus wherein said antigens are derived from conserved external and internal proteins of said virus. Provided are virosomes which may advantageously be formulated as vaccines capable of inducing strong neutralizing antibody and cytotoxic T cell responses as well as protection to pathogenic sources such as a mumps virus. Furthermore, vaccines comprising recombinant DNA derived from DNA encoding conserved external and internal proteins from mumps virus are described.

Abstract: Disclosed are methods for vaccine priming, using co-treatment, at a temporally similar or at a previous time, with a priming antibody capable of priming, or enhancing, or potentiating the effects of a vaccine, or vaccine composition. Also disclosed are methods of using this process to prevent or treat disease.

Abstract: A combined hepatitis A-measles live vaccine, its lyophilized formulations with enhanced storage stability and methods of preparing the same by mixing the viral stocks of hepatitis A virus and measles virus or by propagating the two viruses on same diploid cell substrate are disclosed. The combined live vaccine thus prepared is a useful vaccine for preventing the infections with hepatitis A and measles without causing any interference between antigenicity of the two viruses and any serious adverse events due to their mixing or co-culturing.

Abstract: The present invention is directed to a bacterial delivery system for delivering alphavirus replicon DNA into an animal or animal cells with the replicon encoding one or more heterologous genes to be expressed in the animal or the animal cells. The bacteria are invasive bacteria or attenuated invasive bacteria engineered to contain a DNA vector that encodes the alphavirus replicon in a eukaryotic expression cassette. The heterologous gene can encode an antigen, a therapeutic agent, an immunoregulatory agent, an anti-sense RNA, a catalytic RNA, a protein, a peptide, an antibody or an antigen-binding fragment of an antibody. In a preferred embodiment, the heterologous gene encodes one or more antigens useful as a vaccine for HIV. In addition to the bacterial delivery system, the invention provides methods of introducing and expressing the heterologous gene(s) in animal or animal cells and methods of stimulating or inducing an immune response.

Abstract: The invention provides the use of Hepatitis A virus capsid, or a mucosally immunogenic fragment or epitope thereof, for the manufacture of a mucosal vaccine composition for administration to a mucosal surface of a patient to induce production of serum Immunoglobulin G antibody against Hepatitis A. Preferably the vaccine composition is administered by the intranasal route.

Abstract: A novel vaccine formulation is provided, comprising a hepatitis B component, particularly hepatitis B surface antigen, in combination with aluminum phosphate and 3 de-O-acylated monophosphoryl lipid A.

Abstract: A live hepatitis A virus adapted to growth in MRC-5 cells, which HAV is preferably characterized by suitable attenuation for effective vaccine administration to humans and animals without inactivation, methods for adapting HAV to growth in MRC-5, vaccine compositions and method of vaccinating humans against HAV 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: Novel combined vaccine compositions 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 VZV antigen, an 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: The invention relates to a process for recombinantly preparing picornavirus particles, in particular hepatitis A virus particles, their precursors and particles which are derived therefrom, with a structural protein precursor molecule (P1-2A or P1) and the corresponding P3 region (3ABCD) being coexpressed in cis or in trans.

Abstract: A live hepatitis A virus adapted to growth in MRC-5 cells, which HAV is preferably characterized by suitable attenuation for effective vaccine administration to humans and animals without inactivation, methods for adapting HAV to growth in MRC-5, vaccine compositions and method of vaccinating humans against HAV infection.

Abstract: This invention relates to hepatitis B virus (“HBV”) core antigen particles that are characterized by multiple immunogen specificities. More particularly, the invention relates to HBV core antigen particles comprising immunogens, epitopes, or other related structures, crosslinked thereto by ligands which are HBV capsid-binding peptides that selectively bind to HBV core protein. Such particles may be used as delivery systems for a diverse range of immunogenic epitopes, including the HBV capsid-binding peptides, which advantageously also inhibit and interfere with HBV viral assembly by blocking the interaction between HBV core protein and HBV surface proteins. Mixtures of different immunogens and/or capsid-binding peptide ligands may be crosslinked to the same HBV core particle. Such resulting multicomponent or multivalent HBV core particles may be advantageously used in therapeutic and prophylactic vaccines and compositions, as well as in diagnostic compositions and methods using them.

Abstract: The invention relates to a vaccine formulation for the prevention of Haemophilus Influenzae Type B (Hib) infections and where the antigen is adsorbed onto aluminium phosphate. The invention also relates to a multivalent vaccine, that is a vaccine for the amelioration or treatment of more than one disease states. The present invention also relates to the production and use of such vaccines in medicine.

Abstract: A method for administering the HAV vaccine to a subject by absorption through a mucosal tissue, particularly through the mucosa of the rectum. The method of the present invention enables the HAV vaccine to be administered to the subject rectally, for example as a suppository or other rectal dosage form, and to successfully immunize the subject against HAV. Thus, the present invention overcomes problems of background art methods of administration, such as systemic administration by injection for example, which require needles, and which are difficult and expensive to perform.

Abstract: Hepatitis can be treated by administering to a patient in need thereof an effective amount of a compound that neutralizes the effects of secreted TNFalpha. Two types of these compounds are extracellular ligand binding proteins of the human p75 TNF receptor, such as etanercept (Enbrel), and humanized monoclonal antibodies that neutralize the activity of TNFalpha, such as inflixamab (Remicade).

Abstract: The invention relates to superantigen mediated expansion of antigen-specific T cells for cancer and infectious agent treatment/prophylaxis. Mice were injected with inactivated B16F10 mouse melanoma cells, followed by injection with a combined SEA/SEB injection or a sham injection on days 3 and 6, followed by day 4 challenge with live melanoma cells. The SEA/SEB recipient mice survived longer post-challenge and had a higher CTLs against tumor cells than did the sham injected mice. SEA/SEB TCR activation has been reported to be independent of antigen specificity of TCRs. This invention provides a method whereby a combination of Staphylococcal enterotoxin superantigens is used to enhance specific immune responses to activating antigens to enhance immune responses against cancers and infectious agents.

Abstract: Disclosed are methods for vaccine priming, using co-treatment, at a temporally similar or at a previous time, with a priming antibody capable of priming, or enhancing, or potentiating the effects of a vaccine, or vaccine composition. Also disclosed are methods of using this process to prevent or treat disease.

Abstract: The present invention discloses simian-human hepatitis A virus chimeric genomes which encode a hepatitis A virus having a chimeric 2C protein. The invention further discloses the use of these viruses or the nucleic acid sequence encoding them as vaccines.

Abstract: A microcarrier based process to produce viral vaccines, of which one example is hepatitis A virus (HAV), is composed of an aggregated microcarrier system of glass coated polystyrene microcarriers and MRC-5 cells which creates a stable environment for the propagation of the virus over even extended infection periods. The microcarrier aggregates formed according to this process eliminate the sloughing of cells from the beads during long cultivations seen in other systems, allowing high virus productivity in microcarrier culture. The methodology is applicable where virus production can be enhanced by creating a stable culture during an extended infection period. Scalable stirred bioreactors are used instead of multiple parallel stationary surface bioreactors.

Abstract: A live hepatitis A virus (HAV) adapted to grow in MRC-5 cells is described, the HAV preferably characterized by suitable attenuation for effective vaccine administration to humans and animals without inactivation. Methods for adapting HAV to grow in MRC-5 cells, vaccine compositions comprising the attenuated HAV, and methods of vaccinating humans against HAV infection are also described.

Abstract: The present invention provides an attenuated hepatitis A virus useful as a vaccine.