Abstract: The present invention provides beverages and pharmaceutical compositions containing a deuterated alcohol according to Formula 1, and provides methods for their manufacture and use. The compositions of the invention are expected to ameliorate some of the negative side effects associated with the consumption of alcohol, such as hangover and facial flushing.

Abstract: Compositions and methods are provided for modulating adeno-associated virus (AAV) infection. For example, compositions and methods are provided for enhancing permissiveness of a target cell to AAV infection (e.g., by increasing levels of AAVR (KIAA0319L) in the cell), for reducing permissiveness of a target cell to AAV infection (e.g., by reducing levels of AAVR in the cell), and for nucleic acid delivery (e.g., by (i) increasing permissiveness of a target cell to AAV infection, e.g., by increasing the amount of AAVR in the cell; and (ii) contacting the target cell with an AAV particle that includes a nucleic acid of interest). Also provided are screening methods and kits for practicing the methods of the disclosure.

Abstract: The present disclosure provides a drug formulation for hepalatide, comprising hepalatide and a buffer salt, and containing or not containing an osmotic regulator and/or an excipient.

Abstract: The present invention relates to a composition comprising a viral antigen, a first protein and a second protein. Optionally, the composition also comprises three different disaccharaides, or, optionally, the composition comprises a primary sugar and at least one, preferably two secondary sugars. The present invention also relates to the use of a viral antigen, a first protein and a second protein for the manufacture of a composition, preferably a vaccine. The present invention furthermore relates to a method of treatment or prevention of virus associates diseases in humans. Moreover, the present invention relates to a method of adapting a virus to a suitable cell-line. The invention is also useful for the production of virus suspensions suitable for making stable, live/inactivated, monovalent and/or polyvalent, liquid/lyophilized rotavirus vaccine compositions for oral and/or nasal or any other suitable route of administration in human.

Abstract: The invention provides an attenuated polio virus having a 5? non-coding region consisting of the 5? non-coding region of Sabin 3, modified so that it does not have a base pair mismatch in stem (a) or (b) of domain V, wherein seven or eight of the base pairs in stems (a) and (b) are U-A or A-U base pairs; and a capsid protein from the Sabin 1, Mahoney, MEF or Saukett strain.

Abstract: Provided herein are methods for immunizing children under six months of age by administering to the child a pharmaceutical composition comprising at least one antigen derived from an influenza virus.

Abstract: The present invention is directed to methods for administering antigenic material to a patient as a vaccine against an infection comprising providing both an antigenic material specific to the desired immunological response desired plus an adjuvant comprised of a peptide of a sequence derived from the sequence of pneumococcal surface adhesin A protein (PsaA). Preferably the peptide comprises a sequences derived from one or more sequences of PsaA that contain the epitope regions or contiguous amino acids of SEQ ID NOs 1 or 2. The invention is also directed to vaccine compositions containing adjuvant of the invention and also adjuvant compositions of the invention.

Abstract: The standard dose of polio vaccines contains 40 D-antigen units of inactivated poliovirus type 1 (Mahoney), 8 D-antigen units of inactivated poliovirus type 2 (MEF-1), and 32 D-antigens units of inactivated poliovirus type 3 (Saukett). The present invention teaches that reduced doses of inactivated poliovirus can maintain adequate or improved level of protection against polio.

Abstract: The present invention relates to the treatment, alleviation, prevention or reduction in the incidence of symptoms, diseases or conditions resulting from or associated with enteroviruses, more particularly the enteroviral infections they cause.

Abstract: The present invention relates to methods for producing dried formulations of biopharmaceutical agents that aim to minimize the loss of activity of the agents upon drying and to provide dried formulations with an extended shelf life. The method comprises the step of drying an aqueous solution comprising, in addition to the biopharmaceutical agent, at least an amino acid, a polyol and a metal salt. Preferably the amino acid is glutamate, the polyol is sorbitol and optionally also mannitol and the metal salt is a magnesium salt. The solution is dried by vacuum drying or by lyophilization. The methods are particularly useful for preparing dried formulations of viruses such as poliovirus or respiratory syncytial virus to be used for vaccination. The invention also relates to dried formulations prepared in accordance with the methods of the invention and to their use as medicaments, e.g. as vaccines.

Abstract: A novel and stable attenuated poliovirus, which replicates in neuroblastoma cells, is produced by engineering an indigenous replication element (cre), into the 5? non-translated genomic region and inactivating the native cre element located in the coding region of 2C (mono-crePV). The stably attenuated poliovirus replicates in a neuroblastoma model (Neuro-2aCD155 tumors) expressing CD155, the poliovirus receptor, and is effective for oncolytic treatment and cure of solid tumors, such as neuroblastoma.

Abstract: This document provides methods and materials involved in making and using liquid vaccine preparations for oral administration. For example, methods and materials for making and using liquid vaccine preparations for oral administration that include a lyophilized or dried vaccine component (e.g., a lyophilized pathogenic agent such as a lyophilized rotavirus preparation) and a liquid edible oil composition (e.g., a liquid edible oil composition containing one or more medium chain triglycerides) are provided. In some cases, liquid vaccine preparations that include a buffer component (e.g., CaCO3) are provided.

Abstract: Disclosed herein are compounds and related compositions for the treatment of viral infection, including RNA viral infection, and compounds that can modulate the RIG-I pathway in vertebrate cells, including compounds that can activate the RIG-I pathway.

Abstract: The present invention relates to methods for making a stabilized powder formulation for inhalation comprising a macromolecule in lyophilized form, a crystalline carrier material, and magnesium stearate.

Abstract: The invention provides an attenuated poliovirus which does not have a base pair mismatch in stem (a) or (b) of domain V of the 5? non-coding region of its genome, wherein at least seven of the base pairs in stems (a) and (b) are U-A or A-U base pairs.

Abstract: The invention provides an attenuated polio virus having a 5? non-coding region consisting of the 5? non-coding region of Sabin 3, modified so that it does not have a base pair mismatch in stem (a) or (b) of domain V, wherein seven or eight of the base pairs in stems (a) and (b) are U-A or A-U base pairs; and a capsid protein from the Sabin 1, Mahoney, MEF or Saukett strain.

Abstract: Described is a process for producing poliovirus, the process comprising: a) providing a serum-free suspension culture of cells, which are primary human retina cells that have been immortalized by expression of adenovirus E1 sequences, b) infecting the cells with poliovirus, at a cell density of between 2×106 cells/ml and 150×106 cells/ml, and c) harvesting poliovirus at a time of between 12 and 48 hours after infection.

Abstract: The invention provides an attenuated poliovirus which does not have a base pair mismatch in stem (a) or (b) of domain V of the 5? non-coding region of its genome, wherein at least seven of the base pairs in stems (a) and (b) are U-A or A-U base pairs.

Abstract: The present invention relates to a process for stabilizing an adjuvant containing vaccine composition, an adjuvanted vaccine composition in dry form and in particular a process for stabilizing an influenza vaccine composition, particularly an adjuvanted influenza vaccine composition in dry form.

Abstract: Provided is a process for the production of poliovirus, comprising the steps of: a) providing a serum-free suspension culture of cells, which are primary human retina (HER) cells that have been immortalized by expression of adenovirus E1 sequences, b) infecting the cells with poliovirus, at a cell density of between 2×106 cells/ml and 150×106 cells/ml, and c) harvesting poliovirus at a time of between 12 and 48 hours after infection.

Abstract: Described is a process for producing poliovirus, the process comprising: a) providing a serum-free suspension culture of cells, which are primary human retina (HER) cells that have been immortalized by expression of adenovirus E1 sequences, b) infecting the cells with poliovirus, at a cell density of between 2×106 cells/ml and 150×106 cells/ml, and c) harvesting poliovirus at a time of between 12 and 48 hours after infection.

Abstract: Disclosed herein are compounds and related compositions for the treatment of viral infection, including RNA viral infection, and compounds that can modulate the RIG-I pathway in vertebrate cells, including compounds that can activate the RIG-I pathway.

Abstract: Disclosed herein are compounds and related compositions for the treatment of viral infection, including RNA viral infection, and compounds that can modulate the RIG-I pathway in vertebrate cells, including compounds that can activate the RIG-I pathway.

Abstract: Disclosed herein are compounds and related compositions for the treatment of viral infection, including RNA viral infection, and compounds that can modulate the RIG-I pathway in vertebrate cells, including compounds that can activate the RIG-I pathway.

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 form 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: The invention provides immunostimulatory compositions and methods of administration thereof. Also provided are methods of administering a tryptanthrin compound in an effective amount to enhance the immune response of a subject to an antigen. Also provided are methods of administering an effective amount of a tryptanthrin to stimulate the immune response in a subject for the treatment of cancer. Further provided are methods of administering a tryptanthrin compounds as an immunotherapeutic in the treatment of infectious diseases.

Abstract: The disclosure relates to immunizing agents and devices.

Abstract: The present invention relates to prevention and treatment of allergic sensitization and diseases associated therewith by treatment with an enterovirus vaccine, wherein the enterovirus does not contain an exogenous nucleic acid sequence that is integrated into the viral genome and that encodes an allergen that induces said allergic sensitization.

Abstract: The present invention relates to a method of drying biological and other labile samples so that they can be preserved as a highly viscous liquid. The method involves the steps of preparing a preservation sample by dissolving/suspending an active agent in a solution of a stabilizing agent, subjecting the preservation sample to such temperature and pressure conditions that the preservation sample looses solvent by evaporation without freezing or bubbling to form a foam and removing solvent until the preservation sample dries to form a highly viscous liquid. The stabilizing solution comprises a glass forming polyol and a second component which decreases the flow rate of the highly viscous liquid formed by the method.

Abstract: Various nucleic acid-based matrixes are provided, comprising nucleic acid monomers as building blocks, as well as nucleic acids encoding proteins, so as to produce novel biomaterials. The nucleic acids are used to form dendrimers that are useful as supports, vectors, carriers or delivery vehicles for a variety of compounds in biomedical and biotechnological applications. In particular, the macromolecules may be used for the delivery of drugs, genetic material, imaging components or other functional molecule to which they can be conjugated. An additional feature of the macromolecules is their ability to be targeted for certain organs, tumors, or types of tissues. Methods of utilizing such biomaterials include delivery of functional molecules to cells.

Abstract: Disclosed are dosage forms and related methods, that include a first population of synthetic nanocarriers that have one or more first antigens coupled to them, one or more second antigens that are not coupled to the synthetic nanocarriers, and a pharmaceutically acceptable excipient.

Abstract: A novel and stable attenuated poliovirus, which replicates in neuroblastoma cells, is produced by engineering an indigenous replication element (cre), into the 5? non-translated genomic region and inactivating the native cre element located in the coding region of 2C (mono-crePV). The stably attenuated poliovirus replicates in a neuroblastoma model (Neuro-2aCD155 tumors) expressing CD155, the poliovirus receptor, and is effective for oncolytic treatment and cure of solid tumors, such as neuroblastoma.

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 invention relates to a preservation composition, a formulation comprising a preservation mixture of glutamate, a saccharide, and a polymer. Said preservation mixture is advantageously used for the preservation of a biological compound.

Abstract: Live virus vaccines comprise attenuated viruses, while other vaccines comprise killed viruses or parts thereof. It has now been found that the immune response induced by oral poliovirus vaccine (OPV), which is a live vaccine, is cross-reactive with non-polio enteroviruses. OPV is therefore useful in the prevention of non-polio enterovirus diseases, especially Type 1 diabetes mellitus (IDDM). OPV is also useful in combination with killed/subunit non-polio enterovirus vaccines, whereby it prevents harmful side-effects of the killed/subunit vaccine by shifting the immune response from a harmful Th2-type response to a Th1 type response.

Abstract: The present invention relates to a method of drying biological and other labile samples so that they can be preserved as a highly viscous liquid. The method involves the steps of preparing a preservation sample by dissolving/suspending an active agent in a solution of a stabilizing agent, subjecting the preservation sample to such temperature and pressure conditions that the preservation sample loses solvent by evaporation without freezing or bubbling to form a foam and removing solvent until the preservation sample dries to form a highly viscous liquid.

Abstract: The invention provides, inter alia, immunogenic compositions that comprise (a) a first antigen, (b) at least first and second adjuvants, wherein the first adjuvant comprises microparticles and wherein the second adjuvant comprises an imidazoquinoline compound, and (c) a pharmaceutically acceptable excipient, which compositions elicits an immune response when administered to a vertebrate subject. The invention also provides methods of producing immunogenic compositions and methods for using immunogenic compositions (e.g., for treatment), among other benefits.

Abstract: The present invention relates to a method for treating an infection or disease or lesion, in particular an HPV infection. Furthermore, it relates to a vaccine for treating a Human Papillomavirus (HPV) infection or an associated disease or lesion in a subject.

Abstract: Provided is a process for the production of poliovirus, comprising the steps of: a) providing a serum-free suspension culture of cells, which are primary human retina (HER) cells that have been immortalized by expression of adenovirus E1 sequences, b) infecting the cells with poliovirus, at a cell density of between 2×106 cells/ml and 150×106 cells/ml, and c) harvesting poliovirus at a time of between 12 and 48 hours after infection.

Abstract: The present invention provides a composition and method for treating diseases associated with demyelination of the nerves, such as RA, Tremors/Parkinson's Disease, and MS, and for treating non-viral based cancers. By administering measured doses of an immunity-provoking agent and a bacterial antigen activator, patients suffering from RA, MS, Tremors/Parkinson's Disease, and prostrate cancer realized immediate beneficial results with no side effects.

Abstract: Disclosed herein are sterile-filtered lyophilized nanoparticle compositions which contain at least one biodegradable polymer, at least one surfactant, at least one cryoprotective agent and at least one antigen. Also disclosed are methods of making and using such compositions and kits supplying such compositions.

Abstract: The invention encompasses compositions and methods relating to viral polymerases having one or more substitutions of different amino acids at conserved regions of the polymerase yields enzymes with varying rates and fidelity of replication. A universally applicable, polymerase-mechanism-based strategy for production of attenuated viruses and anti-viral vaccines is disclosed.

Abstract: The invention provides an attenuated poliovirus which does not have a base pair mismatch in stem (a) or (b) of domain V of the 5? non-coding region of its genome, wherein at least seven of the base pairs in stems (a) and (b) are U-A or A-U base pairs.

Abstract: The invention provides an immunogenic composition comprising at least one antigen in association with micropar-tides, wherein the microparticles are in the same size range as viruses. In addition the invention also provides vaccine compositions and methods of eliciting immune responses in a subject.

Abstract: The invention encompasses compositions and methods relating to viral polymerases having one or more substitutions of different amino acids at conserved regions of the polymerase yields enzymes with varying rates and fidelity of replication. A universally applicable, polymerase-mechanism-based strategy for production of attenuated viruses and anti-viral vaccines is disclosed. Attenuated viruses serve as vaccines and were shown to provide protection against poliovirus challenge in vivo.

Abstract: The present invention provides a vaccine composition comprising an effective amount of antigen or a nucleic acid encoding antigen, encapsulated in polymeric particles, wherein said polymeric particles comprises nanoparticles, microparticles or combinations thereof, wherein surprisingly the nanoparticle induces cellular response and the microparticle induces humoral response. The invention further provides a method of inducing cellular and/or humoral immune response.

Abstract: Disclosed herein are methods of modulation of the viability of a cell. Further disclosed herein are methods of modulating an immune response. Further disclosed herein are methods of identifying agents capable of modulation of the viability of a cell or an immune response. Further disclosed herein are agents and compositions capable of modulation of the viability of a cell or an immune response.

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: A newly identified serum resistance factor of gram positive bacteria can be used to treat or prevent bacterial infection.

Abstract: Methods are provided for detecting enteroviral antigens in the stomach of patients having symptoms consistent with chronic fatigue syndrome (CFS). The presence of enteroviral viral antigens in the stomach of these patients is then correlated with the patients' symptoms to establish a diagnosis of CFS.