Abstract: Described herein is a vaccine composition and methods of use. In one embodiment, the vaccine composition includes RSV-F protein in combination with an adjuvant. In a more particular embodiment, the vaccine composition includes RSV soluble F protein in combination with a lipid toll-like receptor (TLR) agonist. In a more particular embodiment, the adjuvant comprises Glucopyraonsyl Lipid A (GLA). In a further embodiment, the adjuvant comprises GLA in a stable oil-in-water emulsion (GLA-SE).

Abstract: The invention provides new compositions and methods for immunomodulation of individuals. Immunomodulation is accomplished by administration of immunomodulatory polynucleotide/microcarrier (IMP/MC) complexes. The IMP/MC complexes may be covalently or non-covalently bound, and feature a polynucleotide comprising at least one immunostimulatory sequence bound to a biodegradable microcarrier or nanocarrier.

Abstract: The invention provides compositions of influenza proteins, such as matrix and nucleoprotein, that are presented to an individual's immune system as multimeric displays to induce an immune response. The compositions are optionally associated with any type of immunomodulatory compound (IMC) comprising an immunostimulatory sequences (ISS). The invention further provides compositions of influenza matrix and nucleoproteins that can induce cellular and/or humoral immune response. The invention also provides methods of making and using these compositions, e.g., as a vaccine, for ameliorating symptoms associated with infection with influenza virus or for reducing the risk of infection with influenza virus.

Abstract: The invention provides methods of modulating an immune response to a second antigen which entail administration of a first antigen and an immunostimulatory polynucleotide. Modulation of the immune response is generally manifested as stimulation of a Th1 response.

Abstract: The invention provides methods of preventing and/or treating infection by a respiratory virus such as respiratory syncytial virus (RSV), particularly reducing infection and/or one or more symptoms of respiratory virus infection. A polynucleotide comprising an immunostimulatory sequence (an “ISS”) is administered to an individual which is at risk of being exposed to a respiratory virus, has been exposed to a respiratory virus or is infected with a respiratory virus. The ISS is administered without any antigens of the respiratory virus. Administration of the ISS results in reduced incidence and/or severity of one or more symptoms of respiratory virus infection.

Abstract: The invention provides new compositions and methods for immunomodulation of individuals. Immunomodulation is accomplished by administration of immunomodulatory polynucleotide/microcarrier (IMP/MC) complexes. The IMP/MC complexes may be covalently or non-covalently bound, and feature a polynucleotide comprising at least one immunostimulatory sequence bound to a biodegradable microcarrier or nanocarrier.

Abstract: The invention provides new compositions and methods for immunomodulation of individuals. Immunomodulation is accomplished by administration of immunomodulatory polynucleotide/microcarrier (IMP/MC) complexes. The IMP/MC complexes may be covalently or non-covalently bound, and feature a polynucleotide comprising at least one immunostimulatory sequence bound to a biodegradable microcarrier or nanocarrier.

Abstract: Compositions are provided which include biodegradable microparticles with entrapped or adsorbed antigens, in combination with submicron oil-in-water emulsions. Also provided are methods of immunization which comprise administering to a vertebrate subject (a) a submicron oil-in-water emulsion, and (b) a therapeutically effective amount of a selected antigen entrapped in a microparticle.

Abstract: The invention provides new compositions and methods for immunomodulation of individuals. Immunomodulation is accomplished by administration of immunomodulatory polynucleotide/microcarrier (IMP/MC) complexes. The IMP/MC complexes may be covalently or non-covalently bound, and feature a polynucleotide comprising at least one immunostimulatory sequence bound to a biodegradable microcarrier or nanocarrier.

Abstract: The invention relates to new immunomodulatory compositions which comprise a cationic condensing agent, an immunomodulatory compound, and a stabilizing agent. The compositions of the invention typically form particles which have increased immunomodulatory activity as compared to immunomodulatory compounds not formulated in the compositions of the invention. Also provided are methods of making the compositions and methods for therapeutic use of the compositions.

Abstract: The invention provides methods for the treatment of papillomavirus infections. A polynucleotide comprising an immunostimulatory sequence is administered to an individual who has been exposed to or infected by papillomavirus. The polynucleotide is not administered with papillomavirus antigen. Administration of the polynucleotide results in amelioration of symptoms of papillomavirus infection.

Abstract: Methods are provided for the treatment of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. A polynucleotide comprising an immunostimulatory sequence is administered to a individual who has been exposed to or infected by HBV and/or HCV. The polynucleotide is not administered with a HCV or HBV antigen. Administration of the polynucleotide results in amelioration of symptoms of HBV and/or HCV infection.

Abstract: The invention provides methods of preventing and/or treating infection by a respiratory virus such as respiratory syncytial virus (RSV), particularly reducing infection and/or one or more symptoms of respiratory virus infection. A polynucleotide comprising an immunostimulatory sequence (an “ISS”) is administered to an individual which is at risk of being exposed to a respiratory virus, has been exposed to a respiratory virus or is infected with a respiratory virus. The ISS is administered without any antigens of the respiratory virus. Administration of the ISS results in reduced incidence and/or severity of one or more symptoms of respiratory virus infection.

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 provides classes of immunomodulatory compositions which comprise an average of one or more immunostimulatory sequence (ISS) containing polynucleotide conjugated, or attached, to antigen. The extent of conjugation affects immunomodulatory properties, such as extent of antigen-specific antibody form ration, including Th1-associated antibody formation, and thus these various conjugate classes are useful for modulating the type and extent of immune response. The invention also includes methods of modulating an immune response using these compositions.

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 provides compositions of influenza proteins, such as matrix and nucleoprotein, that are presented to an individual's immune system as multimeric displays to induce an immune response. The compositions are optionally associated with any type of immunomodulatory compound (IMC) comprising an immunostimulatory sequences (ISS). The invention further provides compositions of influenza matrix and nucleoproteins that can induce cellular and/or humoral immune response. The invention also provides methods of making and using these compositions, e.g., as a vaccine, for ameliorating symptoms associated with infection with influenza virus or for reducing the risk of infection with influenza virus.

Abstract: An adjuvant composition, comprising a metabolizable oil and an emulsifying agent, wherein the oil and the detergent are present in the form of an oil-in-water emulsion having oil droplets substantially all of which are less than 1 micron in diameter. In preferred embodiments, the emulsifying agent is also an immunostimulating agent, such as a lipophilic muramyl peptide. Alternatively, an immunostimulating agent separate from the emulsifying agent can be used.

Abstract: The invention provides methods of modulating an immune response to a second antigen which entail administration of a first antigen and an immunostimulatory polynucleotide. Modulation of the immune response is generally manifested as stimulation of a Th1 response.

Abstract: Compositions are provided which include biodegradable microparticles with entrapped or adsorbed antigens, in combination with submicron oil-in-water emulsions. Also provided are methods of immunization which comprise administering to a vertebrate subject (a) a submicron oil-in-water emulsion, and (b) a therapeutically effective amount of a selected antigen entrapped in a microparticle.