Abstract: Compositions for the prevention and treatment of genital herpes, comprising nucleoside modified mRNAs that encode herpes simplex virus (HSV) glycoproteins, including those involved in virus entry and immune evasion, and methods of use thereof.

Abstract: An embodiment of the present disclosure can include a nanocarrier for delivering a cargo to a cell comprising: a bundle domain and a binding domain, the binding domain configured to bind to the cargo. An embodiment of the present disclosure can include a method for delivering a cargo to a cell comprising: introducing an amino-acid based nanocarrier to the cell, the nanocarrier can comprise an alpha-helical protein bundle domain and a binding domain, the cargo can bound to the binding domain and the cargo can be therapeutic cargo.

Abstract: A method for inducing an immune response against HIV in a subject includes the step of preparing an HIV-1 gp120 envelope protein coding sequence particle having an N425K mutation, introducing the HIV-1 gp120 protein coding sequence particle having an N425K mutation into an expression construct using yeast homologous recombination, transfecting a cell with the expression construct, wherein the HIV-1 particle is secreted by the cell, and administering the secreted HIV-1 particle and a pharmaceutically acceptable carrier to the subject, wherein the secreted HIV-1 particle stimulates an immune response in the subject.

Abstract: The present disclosure provides infectious recombinant adeno-associated virus (rAAV) virions that comprise a variant capsid protein and a heterologous nucleic acid. The present disclosure further provides the variant adeno-associated virus (AAV) capsid proteins (and/or a nucleic acid encoding the variant AAV capsid proteins), which confer to an infectious rAAV virion an increased resistance to human AAV neutralizing antibodies. The present disclosure further provides host cells comprising an infectious rAAV virion and/or a nucleic acid encoding a subject variant AAV capsid protein. The present disclosure further provides methods of delivering a heterologous nucleic acid to a target cell where the target cell is contacted with a subject infectious rAAV virion. The present disclosure further provides methods of delivering a gene product to an individual, the methods generally involving administering an effective amount of a subject rAAV virion to an individual in need thereof.

Abstract: The present invention generally relates to polypeptides, polynucleotides, expression vectors, infectious clones, virus particles and immunogenic compositions of recombinant alphaviruses which can be used as vaccines. The present disclosure also relates to methods for eliciting an immune response against alphavirus infection using the immunogenic composition comprising the alphavirus mutants described herein.

Abstract: The present invention is directed to methods of inducing a phenotypic change in a population of monocytes and/or macrophages. The method includes administering to the population of monocytes and/or macrophages, a macrophage stimulating agent coupled to a carrier molecule, wherein the carrier molecule facilitates macropinocytic uptake of the agent by monocytes and macrophages in the population and is defective in neonatal Fc receptor binding, wherein the administering induces a phenotypic change in the monocytes and macrophages in the population.

Abstract: The disclosure provides various immunogens comprising a repeat unit of saccharide of Klebsiella pneumoniae CPS, which has a formula selected from the group consisting of Formulae (I) to (VI) as described herein. Also provided are vaccines including one or more immunogens selected from Formula (I) to (VI) and methods of eliciting an immune response against a Klebsiella pneumoniae and preventing infection of Klebsiella pneumoniae by using an immunogen of the invention.

Abstract: Provided herein are compositions of virus like particles (VLPs) of poliovirus (PV) that have one or more stabilizing mutations that confer a higher degree of thermostability to the N-antigenic form of the VLPs. These VLPs are non-infectious, and thus safer for use in vaccine development and administration to clinical subjects.

Abstract: In certain embodiments, this disclosure relates to conjugates comprising a polypeptide of GM-CSF and a polypeptide IL-4. Typically, the GM-CSF and IL-4 are connected by a linker, e.g., polypeptide. In certain embodiments, the disclosure relates to isolated nucleic acids encoding these polypeptide conjugates, vectors comprising nucleic acid encoding polypeptide conjugates, and protein expression systems comprising these vectors such as infectious viral particles and host cells comprising such nucleic acids.

Abstract: The disclosure describes compositions containing PEGylated compounds using linkers, bivalent polysaccharide covalent PEG compounds, and methods of bivalent polysaccharide-PEG compounds in the development of multivalent vaccines. PEGylated conjugation of capsular polysaccharides to carrier proteins is carried out using homo-bifunctional and/or hetero-bifunctional linkers of specific lengths. Incorporation of bifunctional PEG linkers induces higher titers of functional antibodies with high avidity, eliciting higher immunologic memory, and reduced carrier protein effect. This provides immunochemically cross-reactive capsular polysaccharides wherein one or more cross-reactive capsular polysaccharides are covalently PEG compounded sequentially or concurrently to carrier protein using bifunctional linkers bearing the same or different functional groups.

Abstract: The disclosure describes compositions containing conjugates using novel linkers, bivalent polysaccharide conjugates, and methods of bivalent polysaccharide conjugation in the development of multivalent conjugate vaccines. Conjugation of capsular polysaccharides to carrier proteins is carried out using homo-bifunctional and/or hetero-bifunctional linkers of specific lengths. Incorporation of the linkers and their use in bifunctional linkers induces higher titers of functional antibodies with high avidity, eliciting higher immunologic memory, and reduced carrier protein effect. This provides immunochemically cross-reactive capsular polysaccharides wherein one or more cross-reactive capsular polysaccharides are conjugated sequentially or concurrently to carrier protein using bifunctional linkers bearing the same or different functional groups.

Abstract: A peptide comprising the rhinovirus immunogen peptide of the rhinovirus structural protein 1 (VP1) of rhinovirus C and related vaccines and therapeutic compositions is disclosed.

Abstract: A Staple cartridge assembly for stapling patient tissue is disclosed comprising a staple cartridge including a deck. The deck includes a plurality of staple cavities and is configured to support the tissue. The staple cartridge assembly further includes a plurality of staples removably stored in the staple cavities and an implantable layer positioned adjacent to the deck. The implantable layer comprises a composite absorbable material, wherein the composite absorbable material comprises at least two distinct fibrous materials. At least one freeze-dried medicament is releasably held on at least one of the fibrous materials. The staple cartridge assembly further includes a liquid impermeable film wrapped around the staple cartridge and the implantable layer.

Abstract: Stable immunogenic composition capable of eliciting a robust and durable immune response yielding a measurable increase in neutralizing antibodies at least 200 days post-administration, comprising at least one antigen consisting of a ribosome inactivating protein and at least one antigen comprising a toxin derived from bacterial spores. Method making and using a stable immunogenic composition capable of eliciting a stable immune response yielding a measurable increase in neutralizing antibodies at least 200 days post-administration, comprising providing an immunogenic composition comprising at least one antigen comprising a ribosome inactivating protein and at least one antigen comprising a toxin derived from bacterial spores and administering the immunogenic composition to an individual.

Abstract: The present invention relates to albumin variants with an improved affinity for the neonatal Fc receptor (FcRn) and uses thereof, and in particular to the use of such albumin variants as carriers for immunogens. In some embodiments, the present invention relates to vaccines (e.g., vaccines for mucosal delivery) comprising albumin/immunogen fusion proteins.

Abstract: Disclosed herein are methods and compositions related to therapy for cancer. More specifically, the disclosed methods and compositions are related to the use of smallpox vaccine to induce an effective anti-tumor immune response.

Abstract: The present invention relates to peptides and compositions suitable for use in inducing anti-HIV-1 antibodies. The compositions comprise HIV-1 gp41 membrane proximal external region (MPER) peptide-liposome conjugates for induction of broadly reactive anti-HIV-1 antibodies. The invention also relates to methods of inducing neutralizing anti-HIV-1 antibodies using such compositions.

Abstract: Disclosed herein are methods and compositions related to therapy for cancer. More specifically, the disclosed methods and compositions are related to the use of smallpox vaccine to induce an effective anti-tumor immune response.

Abstract: Herpes Simplex Virus-2 (HSV-2) infection is a major health concern. The present disclosure provides, inter alia, certain highly effective vaccines and immunogenic compositions against HSV-2. The antigens can be used therapeutically or prophylactically.

Abstract: The present application discloses an immunogenic composition comprising N. meningitidis capsular polysaccharides from at least one of serogroups A, C, W135 and Y conjugated to a carrier protein to produce a N. meningitidis capsular polysaccharide conjugate, wherein the average size of each N. meningitidis polysaccharide is above 50 kDa.

Abstract: HIV-1 envelope proteins and fragments that possess naturally occurring and novel engineered epitopes that can be used to elicit (and are recognized by) broadly neutralizing antibodies.

Abstract: Polyvalent, primary isolate nucleic acid compositions for inducing an immune response against HIV are disclosed. The compositions and methods described herein are for the use of a nucleic acid composition that encodes one or more different HIV envelope glycoproteins. The synthetic, codon-optimized DNAs encoding one or more HIV proteins are a combination of different nucleic acids, such as DNA plasmids, generated from primary isolate DNA of different HIV major group genetic clades and/or different proteins. HIV polypeptide compositions for inducing an immune response against HIV are also disclosed. Methods for using the polypeptide compositions before, at the same time as, and/or after administration of the DNA compositions are provided.

Abstract: This invention provides vaccines comprising two or more recombinant Herpes Simplex Virus (HSV) proteins selected from a gD protein, a gC protein and a gE protein; and methods of vaccinating a subject against HSV and treating, impeding, inhibiting, reducing the incidence of, or suppressing an HSV infection or a symptom or manifestation thereof, comprising administration of a vaccine of the present invention.

Abstract: Iscom particles can be used as an adjuvant for preparing of an antigenic composition which comprises live micro-organisms and/or killed micro-organisms and/or antigenic molecules. A composition may comprise at least one iscom particle and one or more live micro-organisms and/or killed micro-organisms and/or antigenic molecules. A kit can comprise at least one compartment containing at least one living organism and at least one compartment containing at least one iscom particle.

Abstract: A method for using inactivated Japanese encephalitis virus particles as an adjuvant of a vaccine is provided. A method for using inactivated Japanese encephalitis virus (JEV) particles as an adjuvant of various vaccines or a mixed vaccine, said JEV particles being obtained by inoculating JEV Beijing-1 strain to Vero cells, culturing said JEV-infected cells to give cultured cells or culture supernatant, purifying JEV particles from said cultured cells or culture supernatant and inactivating said JEV particles with formalin, a method for preparing a (mixed) vaccine which comprises a step of letting inactivated Japanese encephalitis virus be contained, and a mixed vaccine prepared by said method.

Abstract: Disclosed is a vaccine antigen capable of inducing a cross-reacting and neutralizing antibody directed against a high-risk-type human papillomavirus. Specifically disclosed are: a chimeric protein comprising an L2-epitope of a human papillomavirus (HPV) type-16 inserted in a loop region of a human papillomavirus type-16 L1 protein; and a capsid which is a particle formed by the chimeric protein. The loop region to which the L2-epitope is to be inserted is located between an amino acid residue at position-430 and an amino acid residue at position-433. The L2-epitope has an amino acid sequence represented by any one of the following formulae: LYKTCKQAGTCPPDIIPKVEG (SEQ ID NO: 2) (18-38 L2-epitope); GGLGIGTGSGTGGRTGYIPL (SEQ ID NO: 3) (56-75 L2-epitope); and DPVGPLDPSIVSLVEESSFI (SEQ ID NO: 4) (96-115 L2-epitope).

Abstract: The present invention relates to a novel lipoprotein particle, methods for preparing and purifying the same, its use in medicine, particularly in the prevention of malarial infections, compositions/vaccines containing the particle or antibodies against the protein particle such as monoclonal or polyclonal antibodies and use of the same, particularly in therapy. Furthermore, particles with the specific ratio can be prepared by employing yeast, Saccharomyces cerevisiae or Pichia pastoris. In particular it relates to an immunogenic protein particle comprising the following monomers: a. a fusion protein comprising sequences derived from a CS protein of P. vivax and the S antigen of Hepatitis B (CSV-S), and b. S antigen derived from Hepatitis B virus, and characterized in that the ratio of S to CSV-S is in the range 0.1 to 1. Suitably, the ratio of S to CSV-S is in the range 0.19 to 0.30 or 0.68 to 0.80.

Abstract: The present invention provides compositions and methods for stimulating an immune response using cationic lipids alone or in combination with antigens.

Abstract: The instant invention provides materials and methods for producing immunologically active antigens derived from members of the Picornaviridae virus family. The picornavirus antigens of the invention may be in a form for use as a vaccine administered to a subject in a therapeutic treatment or for the prevention of a picornavirus infection. The picornavirus antigens of the invention may be in the form of an immunogenic composition for use in vaccines which are administered for the prevention of an Enterovirus infection. The instant invention further encompasses immunogenic compositions comprising Human enterovirus A, Human enterovirus B, Human enterovirus C, Human enterovirus D antigens and their use in vaccines for the prevention of an Enterovirus infection.

Abstract: A means to elicit a cytotoxic immune response as a result of injecting antigen encoding expression constructs. Minimalistic expression constructs are used that comprise a promoter, a coding sequence and a terminator, and hairpin-shaped oligonucleotides on their ends, to the loop of which cationic peptides are covalently attached. These peptide-coupled expression constructs lead to a cell mediated response type after intradermal injection. The use of a DNA expression construct operable in eucaryotic cells for making a vaccine for intradermal injection to elicit a type 1 cell mediated immune mediated immune response is described.

Abstract: The present invention relates to a method of inducing the production in a patient of anti-HIV antibodies. The method comprises administering to a patient in need thereof an amount of at least one liposome-peptide conjugate in an amount sufficient to effect that induction. The peptide comprises a membrane external proximal region (MPER) epitope and the liposome comprises lysophosphorylcholine or phosphatidylserine.

Abstract: The present invention relates to the field of vaccines for protecting against polio, and in particular to combination vaccines for protecting against polio, diphtheria, tetanus, and pertussis diseases. Specifically, vaccines comprising reduced dose inactivated poliovirus are provided.

Abstract: The invention relates to the identification, sequencing, and isolation of an A25 bacteriophage lysin gene that expresses a protein involved in the lysis of bacterial cells during the phage life cycle. The invention further relates to methods for lysing certain bacteria using lysin, which are useful for example in a diagnostic procedure designed to detect these bacteria.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.

Abstract: The present invention also relates to a method of reducing metastases in a subject comprising administering to the subject a composition comprising a multifunctional molecule comprising a first part which is capable of binding to an antigen bearing target and a second part which is capable of binding to a cell.

Abstract: Described herein are compositions and methods for stimulating an immune response to one or more proteins derived from one or more respiratory pathogens. In particular, the invention relates to alphavirus replicons, alphavirus vector constructs, alphavirus replicon particles expressing one or more antigens derived from one or more respiratory pathogens as well as to method of making and using these immunogenic compositions.

Abstract: The present invention relates to chimeric RSV-F polypeptide and lentivirus or alpha-retrovirus GAG-based virus-like particles (VLPs). The present invention also includes methods of making and using such chimeric VLPs. In certain embodiments, the GAG polypeptide of the chimeric VLPs comprises an HIV or ALV GAG polypeptide.

Abstract: The subject matter of the invention is a method for preparing a vaccine composition comprising at least aluminium oxyhydroxide (AlOOH), and at least the hepatitis B surface antigen and the Haemophilus influenzae type b antigen. According to the invention, the hepatitis B surface antigen is kept adsorbed on the AlOOH, whereas the Hib antigen is kept nonadsorbed. To this end: the hepatitis B surface antigen is adsorbed onto AlOOH in order to obtain an AlOOH/HBsAg complex, then—said AlOOH/HBsAg complex is mixed with the Hib antigen in the presence of cationic amino acids at a concentration of at least 100 mg/l, and of phosphate ions at a concentration of 35 to 45 mMol/l.

Abstract: The present invention relates to compositions comprising a construct comprising the A?1-6 peptide and a pharmaceutically acceptable adjuvant, for the treatment of patients suffering from dementia, in particular dementia of the Alzheimer's type.

Abstract: Nanoparticles for providing immune responses for the treatment or prophylaxis of infection by infectious agents such as viruses, parasites, bacteria, prions and fungi are described which comprises a core including metal and/or semiconductor atoms, wherein the core is covalently linked to a plurality of ligands, the ligands including a carbohydrate residue capable of stimulating an innate immune response, a T cell helper peptide and a danger signal. This platform may then be adapted by including one or more further ligands capable of producing a specific response to a target infectious agent.

Abstract: Complex viruses are assembled from simple protein subunits by sequential and irreversible assembly. During genome packaging in bacteriophages, a powerful molecular motor assembles at the special portal vertex of an empty prohead to initiate packaging. An aspect of the invention relates to the phage T4 packaging machine being highly promiscuous, translocating DNA into finished phage heads as well as into proheads. Single motors can force exogenous DNA into phage heads at the same rate as into proheads and phage heads undergo repeated initiations, packaging multiple DNA molecules into the same head. This shows that the phage DNA packaging machine has unusual conformational plasticity, powering DNA into an apparently passive capsid receptacle, including the highly stable virus shell, until it is full. These features allow for the design of a novel class of nanocapsid delivery vehicles.

Abstract: Vaccines have been studied that comprise (a) D-T-Pw-HepB-Hib antigens and (b) one or more meningococcal conjugate antigens. A number of improvements and variations of these vaccines have been discovered. The vaccines can be prepared extemporaneously at the time of use by mixing together two components: (a) a first component comprising D, T, wP and HBsAg antigens; and (b) a second component comprising a Hib conjugate and one or more meningococcal conjugates.

Abstract: The present invention provides compositions and methods for stimulating an immune response using cationic lipids alone or in combination with antigens.

Abstract: The present invention relates to the use of alpha (2) macroglobulin complexes isolated from the serum of a mammal. The invention also relates to methods for making such complexes and compositions comprising alpha (2) macroglobulin complexes, isolated from the serum of a mammal, wherein such compositions are used in methods for the treatment and prevention of cancer and infectious disease. The invention also relates to methods for treating and preventing cancer and infectious disease using such complexes comprising, isolated from the serum of a mammal. The invention also encompasses methods for production of alpha (2) macroglobulin complexes.

Abstract: A vaccine preparation for treating cancer includes a complex of a hydrophobized polysaccharide and at least one synthetic long peptide derived from a tumor-specific antigenic protein and/or a pathogen-derived antigenic protein. The at least one synthetic long peptide contains at least one CD8+ cytotoxic T-cell recognition epitope and at least one CD4+ helper T-cell recognition epitope. The complex is simultaneously administered to the patient with at least one immunopotentiating agent.

Abstract: The present invention relates, in general, to human immunodeficiency virus (HIV), and, in particular, to a method of inducing neutralizing antibodies to HIV and to compounds and compositions suitable for use in such a method.

Abstract: Disclosed is a nucleic acid molecule comprising a first expressible sequence encoding a protein of interest or polypeptide of interest which contains an MHC Class II-presented epitope, or said encoded protein or peptide. In addition, the nucleic acid molecule comprises a second expressible nucleic acid sequence encoding an antigen presentation enhancing hybrid polypeptide, or said encoded protein or peptide.

Abstract: Disclosed are immunogenic conjugates having the general formula: HA2-XXX-Pr, where HA2 is the influenza HA2 fusion peptide or a portion thereof, XXX is a linker and Pr is the carrier. Methods of producing an immune response in a subject using the disclosed immunogenic conjugates, as well as methods of treating, ameliorating or preventing influenza infection, are also disclosed.

Abstract: The invention provides a method of obtaining a population of antigen-specific T cells from peripheral blood of a host. An embodiment of the method of the invention comprises (i) dividing PBMCs from peripheral blood of a host into more than one sub-population; (ii) contacting the PBMCs with an antigen and IL-2; (iii) obtaining a sample of PBMCs from each sub-population; (iv) identifying an antigen-reactive sub-population by determining by high throughput quantitative PCR the expression of a factor produced by the PBMCs of each sample; (v) dividing the antigen-reactive sub-population into microcultures; (vi) identifying the antigen-reactive microculture; and (vii) expanding the microculture, thereby obtaining a population of T cells specific for the antigen. The invention also provides a population of T cells obtained by the inventive method, a pharmaceutical composition comprising the same, and a method of treating a disease in a host using the pharmaceutical composition.

Abstract: This invention generally relates to cationic oil-in-water emulsions that contain high concentrations of cationic lipids and have a defined oil:lipid ratio. The cationic lipid can interact with the negatively charged molecule thereby anchoring the molecule to the emulsion particles. The cationic emulsions described herein are useful for delivering negatively charged molecules, such as nucleic acid molecules to cells, and for formulating nucleic acid-based vaccines.