Abstract: Methods of preparing influenza viruses having altered immunodominant epitopes in HA, e.g., having one or more residues in one or more of antigenic sites A-E in HA altered, and viral vectors, e.g., influenza virus VLPs or non-influenza viruses or VLPs thereof expressing or having influenza HAs with altered immunogenicity as a result of altered immunodominant epitopes therein are provided.

Abstract: The present invention relates to vaccines comprising at least one mRNA encoding at least one antigen for use in the treatment of a disease in an elderly patient preferably exhibiting an age of at least 50 years, more preferably of at least 55 years, 60 years, 65 years, 70 years, or older, wherein the treatment comprises vaccination of the patient and eliciting an immune response in said patient. The present invention is furthermore directed to kits and kits of parts comprising such a vaccine and/or its components and to methods applying such a vaccine or kit.

Abstract: Binding molecules, including bispecific antibodies that include at least two anti-influenza binding domains are disclosed, including binding molecules having a first binding domain that specifically binds influenza A virus and a second binding domain that specifically binds influenza B virus.

Abstract: The present invention relates to the field of lipid nanoparticles (LPN); more specifically comprising an ionisable lipid, a phospholipid, a sterol, a PEG lipid and one or more nucleic acids. The LNP's of the present invention are characterized in having a minimal average diameter of about 140 nm, thereby inducing a more potent immune response. The present invention provides use of the LNPs for immunogenic delivery of nucleic acid molecules, specifically mRNA; thereby making them highly suitable for use in vaccines, such as for the treatment of cancer or infectious diseases. Finally, methods are provided for preparing such LNP's.

Abstract: The invention provides therapeutic compositions that present an artificial repertoire of mammalian pattern recognition receptor (PRR) agonists, so that the pattern of PRR agonists recapitulates a distinct portion of a PRR agonist signature of a mammalian pathogen. The artificial repertoire of PRR agonists may be formulated together in a therapeutic vehicle for combined presentation to an innate immune cell resident in a target tissue in a mammalian host, and the vehicle adapted to deliver the PRR agonists to the target tissue, so as to modulate an immune response.

Abstract: The present application relates to the field of human immunology, in particular, a herpes simplex virus (HSV) vaccine. The subunit vaccine composition comprises isolated surface glycoproteins from herpes simplex viruses, fusion proteins or fragments thereof mixed in varied combination with a nanoemulsion, which is a potent immune enhancer.

Abstract: The disclosure provides for an isolated recombinant influenza virus having at least one of: a PA gene segment encoding PA with a residue at position 443 that is not arginine, a PB1 gene segment encoding PB1 with a residue at position 737 that is not lysine, a PB2 gene segment encoding PB2 with a residue at position 25 that is not valine or a residue at position 712 that is not glutamic acid, a NS gene segment encoding a NS1 with a residue at position 167 that is not proline, a HA gene segment encoding a HA with a residue at position 380 that is not threonine, or any combination thereof, and methods of making and using the virus.

Abstract: Provided herein are membrane enveloped virus-like particles (VLPs), and methods of use and synthesis thereof. In particular, yeast-cell-derived VLPs are provided that comprise surface-displayed glycoproteins and/or multiple virally-derived proteins.

Abstract: The present invention relates to compositions and methods for the treatment and prevention of canine influenza virus (CIV) and CIV-related pathology. The present invention is based on the development of mutant CIV, having one or more mutations in segment 8, which induces a CIV-specific immune response in a subject.

Abstract: Disclosed is a universal influenza vaccine composition and corresponding methods comprising at least one attenuated live-attenuated influenza vaccine. The vaccine composition can exhibit a cross-protective effect against a wide range of influenza viruses and can ensure a strong protection efficacy, a wide range of protection, and safety. In addition, a vaccination method of heterologous live vaccines of the present invention induces various immunological effects so that cross-immunogenicity and cross-protective ability are remarkably increased, and thus is expected to be usefully utilized as a universal influenza prevention method. A person who has a basal immunity through infection with an influenza virus or vaccination with an influenza vaccine can be regarded as being in a state where primary vaccination has already been performed, single vaccination with a live vaccine induces an enhanced cross-immune response, and thus it is possible to expect a wide range of protective effects against various viruses.

Abstract: The present disclosure provides a method for quantifying a vaccine. The method includes the steps of: 1) providing a plurality of standard mixtures, each of the standard mixtures having a standard antigen and an aluminum based adjuvant; 2) mixing a stabilizing solution with the vaccine and each of the standard mixtures; 3) determining dosages of the standard antigens in the standard mixtures to establish a standard curve; and 4) determining a dosage of a target antigen in the vaccine according to the standard curve.

Abstract: The present invention relates to an immunogenic composition comprising: a) a modified live H3 virus of swine influenza, and b) a modified live H1 virus of swine influenza. Furthermore, the present invention relates to methods for immunizing a subject comprising administering to such subject the immunogenic composition of the present invention. Moreover, the present invention relates to methods of treating or preventing clinical signs caused by swine influenza virus in a subject of need, the method comprising administering to the subject a therapeutically effective amount of an immunogenic composition according to the present invention.

Abstract: The present invention provides an adjuvant for vaccine including a Dectin-1 ligand and a TLR agonist, a vaccine including the adjuvant for vaccine and at least one antigen, and the like.

Abstract: The present invention relates to an immunogenic composition comprising: a) a modified live H3 virus of swine influenza, and b) a modified live H1 virus of swine influenza. Furthermore, the present invention relates to methods for immunizing a subject comprising administering to such subject the immunogenic composition of the present invention. Moreover, the present invention relates to methods of treating or preventing clinical signs caused by swine influenza virus in a subject of need, the method comprising administering to the subject a therapeutically effective amount of an immunogenic composition according to the present invention.

Abstract: Methods and uses are provided for inducing an immune response comprising at least two administrations of an immunogenic composition, wherein a lower dose is given in the second administration than in the first administration, and wherein the second administration may be unadjuvanted.

Abstract: Provided herein are probiotic compositions and methods to enhance bacterial diversity in the intestinal tract of a subject. A probiotic is provided comprising lymphoid tissue-resident commensal bacteria, and optionally IL-10, IL-22, and/or hepcidin. The probiotic can be used to promote intestinal health or to treat or prevent intestinal disease or condition.

Abstract: Described herein is the generation of optimized H1N1 influenza HA polypeptides for eliciting a broadly reactive immune response to H1N1 influenza virus isolates. The optimized HA polypeptides were developed through a series of HA protein alignments, and subsequent generation of consensus sequences, based on selected H1N1 viruses isolated from 1918-2011. Provided herein are optimized H1N1 HA polypeptides, and compositions, fusion proteins and VLPs comprising the HA polypeptides. Further provided are codon-optimized nucleic acid sequences encoding the HA polypeptides. Methods of eliciting an immune response against influenza virus in a subject are also provided by the present disclosure.

Abstract: The present invention relates to equine influenza virus (EIV) isolates that when administered in vaccines to equine provide protection against currently emerging EIV strains in the U.S. The present invention also relates to inactivated EIV isolates. In addition, the present invention also relates to safe and efficacious vaccines that comprise the EIV isolates, as well as to corresponding subunit vaccines. The present invention further relates to methods of administering such safe and efficacious vaccines to equine.

Abstract: An improved method for the manufacture of an oil-in-water emulsion involves circulation of emulsion components between a first container and a second container via a homogenizer and/or via a microfluidization device. Usefully, all of the emulsion components from the first container are emptied before being returned.

Abstract: The invention provides an isolated H3 equine influenza A virus, as well as methods of preparing and using the virus, and genes or proteins thereof.

Abstract: The present invention encompasses engineered Newcastle Disease Virus (NDV) vaccines or compositions. The vaccine or composition may be a recombinant vaccine. The invention also encompasses recombinant vectors encoding and expressing avian pathogen antigens, more specifically avian influenza proteins, epitopes or immunogens. Such vaccines or compositions can be used to protect animals, in particular avian, against disease.

Abstract: The present invention provides a system for analyzing interactions between glycans and interaction partners that bind to them. The present invention also provides HA polypeptides that bind to umbrella-topology glycans, and reagents and methods relating thereto.

Abstract: Aspects of the invention provide therapeutic recombinant protein preparations and methods of preparing therapeutic recombinant protein, which methods include contacting recombinant protein preparations with zwitterionic detergent at or above critical micelle concentration of the detergent.

Abstract: The present invention provides a recombinant influenza virus vector comprising an NS gene encoding a truncated NS1 protein of at least 73 and up to 122 amino acids of the N-terminus of the respective wild type NS 1 protein, wherein said vector replicates in IFN-sensitive tumor cells and does not replicate in normal, non-tumor cells, and expresses a heterologous immunostimulatory polypetide. The invention further provides a pharmaceutical composition containing said influenza virus vector, its use for the treatment of cancer patients and methods for producing said influenza virus vaccine.

Abstract: The invention provides compositions comprising liposomes, an antigen capable of inducing a humoral immune response, a carrier comprising a continuous phase of a hydrophobic substance, and an adjuvant that activates or increases the activity of TLR2. The invention also provides uses for such compositions in inducing a humoral response and methods for their use in the treatment of a disease, disorder or ailment ameliorated by a humoral immune response.

Abstract: The invention provides an isolated H3 equine influenza A virus, as well as methods of preparing and using the virus, and genes or proteins thereof.

Abstract: Improved methods for the production of reassortant influenza viruses are provided.

Abstract: The present invention relates to an immunogenic composition comprising: a) a modified live H3 virus of swine influenza, and b) a modified live H1 virus of swine influenza. Furthermore, the present invention relates to methods for immunizing a subject comprising administering to such subject the immunogenic composition of the present invention. Moreover, the present invention relates to methods of treating or preventing clinical signs caused by swine influenza virus in a subject of need, the method comprising administering to the subject a therapeutically effective amount of an immunogenic composition according to the present invention.

Abstract: The invention relates to a method for producing influenza infectious viruses wherein CHO cells are infected with a seed of infectious influenza virus which has been generated by transfecting cells with an appropriate set of expression vectors. The invention also relates to a recombination cassette, and to a vector comprising said recombination cassette, that may be used in methods for producing infectious viruses, and particularly in the method according to the invention.

Abstract: An influenza vaccine is administered by a multi-dose regimen, in which (i) a first dose is administered with an adjuvant and (ii) a later dose is administered either without an adjuvant or with a different adjuvant. Thus the invention provides the benefits of a two-dose regimen without also doubling the supply need for a given adjuvant.

Abstract: The invention relates to adjuvanted vaccine formulations, in particular influenza vaccines for intranasal delivery. Provided is an adjuvanted influenza vaccine formulation, comprising (i) peptidoglycan microparticles obtained from a Gram-positive bacterium and (ii) at least one influenza virus antigen or antigenic preparation thereof, which antigen or antigenic preparation is not fused or otherwise covalently attached to a proteinaceous peptidoglycan binding moiety.

Abstract: Provided herein are attenuated influenza viruses and methods of making attenuated influenza viruses.

Abstract: The invention relates to compositions and methods for the preparation, manufacture and therapeutic use ribonucleic acid vaccines (NAVs) comprising polynucleotide molecules encoding one or more antigens.

Abstract: An intradermal delivery system comprises an immunogenic composition comprising a TLR agonist and immunogen and a microneedle. The immunogenic composition may comprise a solid biodegradable microneedle or a solid coated microneedle. The intradermal delivery system may be formulated into a skin patch.

Abstract: The invention provides an isolated H3 equine influenza A virus, as well as methods of preparing and using the virus, and genes or proteins thereof.

Abstract: The present invention relates to a probiotic cell transformed with a construct suitable to overexpress and display on the surface of the probiotic cell a fusion protein comprising at least a portion of a transport protein coupled to at least a portion of one or more antigenic proteins or peptides. Probiotic-derived vesicles displaying this fusion protein as well as methods of inducing an immune response using the probiotic cells or vesicles are also disclosed.

Abstract: The present invention provides a novel influenza virus wherein both the NS and the PB1 gene segments are modified and wherein the PB1-F2 open reading frame is modified by introduction of at least one stop codon. Specifically, the influenza virus is lacking functional NS1 and PB1-F2 proteins. Additionally, a vaccine formulation comprising the modified influenza virus is provided and its use for prevention of influenza vaccination.

Abstract: The present invention provides an internal positive control for contaminating viruses. The invention provides the use of a second virus as an exogenous internal positive control in methods for verifying the reliability of an assay to detect a first virus, in methods of ensuring the absence of the first virus in a biological sample or pharmaceutical sample and in methods of manufacturing a vaccine free from a first virus.

Abstract: The invention provides methods for culturing yeast at a neutral pH level. Yeast cultured under neutral pH conditions exhibit desirable characteristics useful for biological purposes, such as the development of vaccines, prophylactics and therapeutics. The invention also provides for compositions and kits comprising yeast grown using the methodologies disclosed herein.

Abstract: The present invention relates, in general, to attenuated swine influenza viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. In particular, the invention relates to attenuated swine influenza viruses having modifications to a swine NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. These viruses replicate in vivo, but demonstrate decreased replication, virulence and increased attenuation, and therefore are well suited for use in live virus vaccines, and pharmaceutical formulations.

Abstract: In a method for processing biological materials for flow cytometry evaluation for virus particles, a mixture including biological material and purification particles is centrifuged to prepare a centrifuged composition including a supernatant that may be further processed prior to the flow cytometry evaluation. The purification particles include porous cores functionalized to capture smaller-size impurities in a biological material sample and a porous size-exclusion shell surrounding the core to exclude larger-size components of the biological material from entering into the core. Multiple samples may be processed in multi-sample processing units. A product may contain a sealed container with the unit quantity of purification particle in a storage liquid and a kit may include such a sealed container and a centrifugal filter.

Abstract: The invention provides an isolated H3 equine influenza A virus, as well as methods of preparing and using the virus, and genes or proteins thereof.

Abstract: The present invention relates, in general, to attenuated negative-strand RNA viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. The invention also relates to the development and use of IFN-deficient systems for selection of such attenuated viruses. In particular, the invention relates to attenuated influenza viruses having modifications to the NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. The mutant viruses replicate in vivo but demonstrate reduced pathogenicity, and therefore are well suited for live virus vaccines, and pharmaceutical formulations.

Abstract: The subject invention pertains to isolated influenza virus that is capable of infecting canids and causing respiratory disease in the canid. The subject invention also pertains to compositions and methods for inducing an immune response against an influenza virus of the present invention. The subject invention also pertains to compositions and methods for identifying a virus of the invention and diagnosing infection of an animal with a virus of the invention.

Abstract: The present invention relates to cGMP protein kinase (PKG) and regulatory domains and methods of use thereof. The structural determination of PKG domains is also described. cGMP independent PKG activators and uses thereof are also described.

Abstract: The present invention provides a new class of peptides related to rapid replication and high human mortality, and their use in diagnosing, preventing and treating disease including vaccines and therapeutics for emerging viral diseases and methods of identifying the new class of peptides and related structures.

Abstract: Provided herein are nucleic acid sequences that encode novel consensus amino acid sequences of HA hemagglutinin, as well as genetic constructs/vectors and vaccines expressing the sequences. Also provided herein are methods for generating an immune response against one or more Influenza A serotypes using the vaccines that are provided.

Abstract: The invention concerns a recombinant modified vaccinia virus Ankara (MVA virus) expressing at least two external influenza virus antigens and/or an epitope of one or more of the at least two antigens and at least two internal influenza virus antigens and/or an epitope of the at least two antigens. The invention, thus, concerns a recombinant MVA virus encoding multiple external and/or internal influenza virus antigens, preferably from multiple influenza virus strains. The invention further concerns the use of said recombinant MVA in preparing a medicament and vaccine for influenza virus. Further encompassed by the present invention are methods, composition and kits.

Abstract: The present invention encompasses an expression vector that is capable of generating a virus from a segmented genome. In particular, a single expression vector may be utilized to produce influenza virus in cultured cells. The expression vector can be delivered in a purified DNA form or by a suitably designed bacterial carrier to cells in culture or to animals. This invention increases the virus generation efficiency, which benefits vaccine development. The bacterial carrier harboring such a plasmid encoding an attenuated virus may be used as a vaccine against corresponding viral disease.

Abstract: The present invention relates to methods for inducing an immune response to influenza in a subject comprising administering a nanoemulsion vaccine composition comprising an influenza immunogen or protein.