Abstract: The present invention is in the field of treating and/or preventing viral infections. In particular, the present invention relates to immunogenic or pharmaceutical compositions comprising self-replicating RNA molecules that encode influenzavirus antigens for treating and/or preventing influenza infections.

Abstract: The present invention provides vaccine or immunogenic compositions comprising novel antigens derived from the equine strain of influenza H3N8. These proteins and specific immunogenic domains are effective as primary universal influenza antigens. The disclosed vaccines or immunogenic compositions are highly effective in inducing HA specific antibodies reactive to different influenza viruses, mucosal and systemic immune responses, and cross-protection regardless of influenza virus subtypes. In some embodiments, the vaccine is cross-protective against two or more (e.g., 2, 3, 4, 5, or 6) subtypes of influenza with or without the use of an adjuvant.

Abstract: A method for producing at least one microneedle containing a vaccine for transdermal delivery of the vaccine to a patient includes preparing microparticles or nanoparticles of encapsulated vaccine by preparing a solution comprising a vaccine antigen and a biocompatible polymer matrix; and spray drying the solution to form the microparticles or nanoparticles. The method includes the further steps of preparing a film composition including at least one pre-polymer solution; preparing a suspension comprising the microparticles or nanoparticles and the film composition; loading the suspension into a 3D printer; printing, via the 3D printer, at least one microneedle made from the suspension; and, converting the pre-polymer solution into a cross-linked biopolymer by exposing the at least one microneedle to UV light. Also disclosed are microneedles containing a vaccine for transdermal delivery.

Abstract: Disclosed herein are immunogenic compositions for producing immediate and sustained immunity to infectious viral and bacteriological pathogens. A univalent immunogenic composition is disclosed comprising an isolated antigen and a polynucleotide formulated into a nanoparticle or liposome. Furthermore, multivalent immunogenic compositions are disclosed comprising multiple univalent immunogenic compositions. Also disclosed, are methods of inducing protective or therapeutic immune responses in individuals comprising administering one or more univalent immunogenic compositions.

Abstract: Described herein are methods and compositions for vaccination against influenza. The compositions comprise recombinant engineered influenza hemagglutinin polypeptides. Also disclosed are methods of producing recombinant engineered influenza hemagglutinin polypeptides in cell-based systems.

Abstract: The present invention provides recombinant viral vectors that contain and express antigens of avian pathogens, compositions comprising the recombinant viral vectors, polyvalent vaccines comprising the recombinant viral vectors. The present invention further provides methods of vaccination against a variety of avian pathogens and method of producing the recombinant viral vectors.

Abstract: A method for forming microspheres containing bioactive material, comprising dissolving a polymer matrix, such as albumin or beta-cyclodextrin, in an aqueous medium in a first vessel; contacting the dissolved polymer matrix with a crosslinking agent, such as glutaraldehyde, to crosslink the polymer matrix and the crosslinking agent; neutralizing with sodium bisulfate any excess crosslinking agent remaining after crosslinking is substantially complete; solubilizing in a second vessel a bioactive material in an aqueous solution; mixing the solubilized bioactive material together with the neutralized crosslinked polymer matrix in solution to form a mixture; and, spray drying the mixture to produce nanospheres, whereby substantial bioactivity of the biomaterial is retained upon cellular uptake.

Abstract: The present invention discloses and claims virus like particles (VLPs) that express and/or contains seasonal influenza virus proteins, avian influenza virus proteins and/or influenza virus proteins from viruses with pandemic potential. The invention includes vector constructs comprising said proteins, cells comprising said constructs, formulations and vaccines comprising VLPs of the inventions. The invention also includes methods of making and administrating VLPs to vertebrates, including methods of inducing substantial immunity to either seasonal and avian influenza, or at least one symptom thereof.

Abstract: The present invention relates to vaccine products for the treatment or prevention of viral infections. Further provided are methods of reducing contaminants associated with the preparation of cell culture vaccines. Residual functional cell culture DNA is degraded by treatment with a DNA alkylating agent, such as ?-propiolactone (BPL), thereby providing a vaccine comprising immunogenic proteins derived from a virus propagated on cell culture, substantially free of residual functional cell culture DNA.

Abstract: The present invention provides co-administration (e.g., immunogenic cocktail and/or prime-boost regimens) of computationally optimized H5N1 influenza hemagglutinin (HA) polypeptides that. Co-administration of the optimized H5N1 influenza hemagglutinin (HA) polypeptides facilitates synergistic neutralization of viral infection and provides for improved protective immunity (e.g., a broad reactive immune response) to multiple H5N1 influenza virus clades and strains.

Abstract: The present invention discloses and claims virus like particles (VLPs) that express and/or contains seasonal influenza virus proteins, avian influenza virus proteins and/or influenza virus proteins from viruses with pandemic potential. The invention includes vector constructs comprising said proteins, cells comprising said constructs, formulations and vaccines comprising VLPs of the inventions. The invention also includes methods of making and administrating VLPs to vertebrates, including methods of inducing substantial immunity to either seasonal and avian influenza, or at least one symptom thereof.

Abstract: The present disclosure generally relates to viral-based expression systems suitable for the production of molecule of interests in recombinant host cells. The disclosure particularly relates to nucleic acid constructs, such as expression vectors, containing a modified arterivirus genome or replicon RNA in which at least some of its original viral sequence has been deleted. Also included in the disclosure are viral-based expression vectors including one or more expression cassettes encoding heterologous polypeptides. In some embodiments, the expression cassettes are configured and positioned at defined locations on the viral genome so as to enable expression of the heterologous polypeptides in a tunable manner.

Abstract: The invention relates to a novel drug delivery vehicle. Various embodiments of the invention provide a hybrid polymerized liposomal nanoparticle comprising both polymerizable lipids and non-polymerizable lipids. Therapeutic agents can be loaded into the polymerized liposomal nanoparticle and targeting agents can be conjugated to the surface of the polymerized liposomal nanoparticle. Also described in the invention are methods, compositions and kits that utilize the hybrid polymerized liposomal nanoparticle to treat disease conditions such as various cancers.

Abstract: A method of producing a virus like particle (VLP) in a plant comprising modified hemagglutinin is provided. The method comprises introducing a nucleic acid comprising a regulatory region active in the plant and operatively linked to a nucleotide sequence encoding a modified influenza hemagglutinin (HA) protein into the plant, or portion of the plant, the modified HA protein comprises a modified proteolytic loop. Followed by incubating the plant or portion of the plant under conditions that permit the expression of the nucleic acids, thereby producing the VLP. The modified proteolytic loop may comprise one or more protease cleavage sites exhibiting reduced or abolished cleavage by a protease. The nucleotide sequence encoding the HA may be selected from the group consisting of B HA, C, H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16. Also described is a virus like particle (VLP) produced by the method, and plants expressing the VLP.

Abstract: This disclosure relates to using EGFR pathway inhibitors in combination with compositions comprising an antigen to increase, elicit, or improve an antigen or vaccine-induced immune response. In certain embodiments, the EGFR pathway inhibitor is administered under conditions such that memory cells to the antigen are formed in a subject. In certain embodiments, the composition is a vaccine. In certain embodiments, the EGFR pathway inhibitor and vaccine are administered to the skin epidermis or dermis.

Abstract: Disclosed herein are synthetic oligoribonucleotides that form hairpin loop structures. The oligoribonucleotides can be used in the treatment of viral infection including prophylactic treatments. The oligoribonucleotides can also be used as adjuvants.

Abstract: The present disclosure provides compositions and methods useful for treating influenza. As described herein, provided compositions and methods are based on the development of certain compositions that include an influenza virus hemagglutinin antigen in combination with lipid vesicles that include a non-ionic surfactant (NISVs) and optionally an adjuvant. In certain embodiments, provided compositions remain potent even when they are not stored in a standard cold-chain system (i.e., they are thermostable).

Abstract: The present invention relates to a vaccine composition comprising: —at least one prophylactically active agent against influenza, and —at least one adjuvant, said adjuvant being a derivative of a galactosylceramide, for use in the treatment of influenza.

Abstract: The present invention relates to a pharmaceutical composition for inhibiting or preventing viral infection, which comprises an effective dose of poly-gamma-glutamic acid (?-PGA), and more particularly, to a pharmaceutical composition, a functional food, and a feedstuff additive capable of inhibiting viral infection and preventing viral diseases, which comprise poly-gamma-glutamic acid having an infection-inhibiting effect against viruses, such as an influenza virus, inducing respiratory infection or systemic infection, as an effective ingredient. The composition containing poly-gamma-glutamic acid as an effective ingredient according to the present invention, is effective for use as an animal feedstuff additive or a pharmaceutical agent for preventing influenza virus infection and various viral diseases as well as a pharmaceutical composition and a functional food to promote human health.

Abstract: The present disclosure relates to an autologous biological cancer vaccine and to a method for preparing the same. The vaccine of the present application is a biological vaccine obtained from overexpressed proteins in the serum of cancer patients, proteins to which have been added immunological adjuvants such as an attenuated virus DNA and amino acids in order to cause an immune response, blocking tumor cells. The preparation method includes obtaining the antigen associated with the tumor as well as the vaccine preparation with attenuated virus DNA, combining the components under conditions that have been determined by experimentation, filtration and refrigeration.

Abstract: A method of providing protection against pneumococcal infection in a subject is disclosed. The method includes steps of administering to the subject a composition that includes combination of three recombinant pneumococcal neuraminidases: NanA, NanB, and NanC of S. pneumoniae strains CGSP14, wherein administration of the recombinant pneumococcal neuraminidases elicits an immune response to S. pneumoniae, and treats the subject. In one embodiment, the method further includes a step of adding adjuvants to enhance the immune response. The method also includes a step of using passive antibodies, wherein said passive antibodies are anti-neuraminidase antibodies generated from neuraminidases-immunized humanized animals: NanA, NanB, and NanC. Meanwhile, this invention also provides a method for the molecular diagnosis of pneumococcal infection.

Abstract: The present invention is directed to a pharmaceutical composition including (e.g., for use as an adjuvant) a (negatively charged) nucleic acid comprising complex comprising as a carrier cationic or polycationic compounds (e.g. peptides, proteins or polymers) and as a cargo at least one nucleic acid (molecule) and at least one antigen that is selected from an antigen from a pathogen associated with infectious disease; an antigen associated with allergy or allergic disease; an antigen associated with autoimmune disease; or an antigen associated with a cancer or tumour disease, or in each case a fragment, variant and/or derivative of said antigen. The pharmaceutical composition allows for efficient induction of an adaptive immune response directed against said antigen. The present invention furthermore provides kits, as well as the use of the pharmaceutical composition or the kit as a vaccine, particularly in the treatment of infectious diseases, allergies, autoimmune diseases and tumour or cancer diseases.

Abstract: A method of producing a virus like particle (VLP) in a plant is provided. The method comprises introducing a first nucleic acid and a second nucleic acid into the plant, or portion of the plant. The first nucleic acid comprises a first regulatory region active in the plant and operatively linked to a nucleotide sequence encoding a structural virus protein. The second nucleic acid comprises a second regulatory region active in the plant and operatively linked to a nucleotide sequence encoding a channel protein, for example but not limited to a proton channel protein. The plant or portion of the plant is incubated under conditions that permit the expression of the nucleic acids, thereby producing the VLP.

Abstract: The invention relates to a flu virus hemagglutinin-specific monoclonal antibody which recognizes an antigenic structure present both on the H1 and H3 subtypes of the hemagglutinins of type A flu viruses and on the hemagglutinin of type B flu viruses. Within type B flu viruses, the antigenic structure is present on the hemagglutinins of type B flu viruses belonging to the B/Victoria group and/or to the B/Yagamata group.

Abstract: An influenza vaccine comprising an influenza hemagglutinin-containing antigen which is subjected to a treatment at a suitable low pH or other suitable conditions to obtain a suitable degree of loss of potency, and the method of making it are provided. The vaccine not only induces an increased cross-reactive immune response and cross protection, but can also induce a strain-specific immune response and protection like current inactivated vaccines. A method of administering influenza vaccines is also provided to induce an increased cross-reactive immune response and cross protection, which is especially suitable for use in emergency situations such as a pandemic.

Abstract: The present invention relates to a nucleic acid sequence, comprising or coding for a coding region, encoding at least one peptide or protein comprising a pathogenic antigen or a fragment, variant or derivative thereof, at least one histone stem-loop and a poly(A) sequence or a polyadenylation signal. Furthermore the present invention provides the use of the nucleic acid for increasing the expression of said encoded peptide or protein. It also discloses its use for the preparation of a pharmaceutical composition, especially a vaccine, e.g. for use in the treatment of infectious diseases. The present invention further describes a method for increasing the expression of a peptide or protein comprising a pathogenic antigen or a fragment, variant or derivative thereof, using the nucleic acid comprising or coding for a histone stem-loop and a poly(A) sequence or a polyadenylation signal.

Abstract: The present invention provides safe, stable, efficacious, and cost-effective vaccines based on viral expression vectors that include a parainfluenza virus 5 (PIV5) genome including a heterologous nucleotide sequence expressing a heterologous polypeptide. In some embodiments, the heterologous nucleotide sequence is inserted closer to the leader than between the hemagglutinin-neuroaminidase (HN) gene and the large RNA polymerase protein (L) gene of the PIV5 genome. In some embodiments, the heterologous nucleotide sequence is inserted between the small hydrophobic protein (SH) gene and the hemagglutinin-neuroaminidase (HN) gene of the PIV 5 genome.

Abstract: The present invention relates to novel virus-like particles (VLPs) comprising a matrix protein derived from a first plant enveloped virus and a surface polypeptide. The surface polypeptide comprises (a) a surface exposed portion derived from a target polypeptide (b) a transmembrane domain, and (c) a cytosolic tail derived from a transmembrane (e.g., glycoprotein) of a second plant enveloped virus. The target polypeptide may be antigenic or therapeutic. The first and the second plant enveloped viruses may be the same. Either plant enveloped virus may be a plant rhabdovirus. Also provided are methods of making and using the VLPs.

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: This invention relates to a method for vaccination which is effective for eliciting an enhanced antigen-specific immune response in a mammal, fish or bird. The method is particularly effective for protecting a mammal, fish or bird from a disease including cancer, a disease associated with allergic inflammation, or an infectious disease. Also disclosed are therapeutic compositions useful in such a method.

Abstract: Methods that stimulate a protective immune response in a subject include a portion of a protein from a naturally occurring viral hemagglutinin, wherein the protein portion includes at least a portion of a globular head and at least a portion of at least one secondary structure that causes the globular head to essentially retain its tertiary structure, and wherein the protein portion lacks a transmembrane domain, a cytoplasmic domain and an HA2 subunit. Compositions administered to the subject can further include a carrier and can be administered in single or multiple doses.

Abstract: The development of a computationally optimized influenza HA protein that elicits broadly reactive immune response to all H5N1 influenza virus isolates is described. The optimized HA protein was developed through a series of HA protein alignments, and subsequent generation of consensus sequences, for clade 2 H5N1 influenza virus isolates. The final consensus HA amino acid sequence was reverse translated and optimized for expression in mammalian cells. Influenza virus-like particles containing the optimized HA protein are an effective vaccine against H5N1 influenza virus infection in animals.

Abstract: An improved method for the manufacture of an oil-in-water emulsion comprises using a microfluidisation device whose interaction chamber comprises a plurality of Z-type channels upstream of a back pressure chamber.

Abstract: Compositions that include Toll-like Receptor 5 agonists and at least a portion of at least one viral antigen can be employed in methods that stimulate an immune response in a subject, in particular, a protective immune response in a subject. Compositions can be associated with particles and employed in the methods in relatively low doses to provide protective immunity to viral infection.

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 present invention relates to influenza vaccine formulations and vaccination regimes for immunising against influenza disease, their use in medicine, in particular their use in augmenting immune responses to various antigens, and to methods of preparation. In particular, the invention relates to multivalent influenza immunogenic compositions comprising an influenza antigen or antigenic preparation thereof from at least two influenza virus strains, at least one strain being associated with a pandemic outbreak or having the potential to be associated with a pandemic outbreak, in combination with an oil-in-water emulsion adjuvant.

Abstract: Current approaches to influenza vaccination focus either on seasonal strains or pandemic strains. Current seasonal vaccines typically include antigens from two influenza A strains (H1N1 and H3N2) and one influenza B strain. Current pandemic vaccines focus on H5N1 influenza A virus strains. It is an object of the invention to provide further and improved ways of preparing vaccines that can raise immunity against both seasonal and pandemic strains.

Abstract: Described herein is the development of a computationally optimized influenza HA protein that elicits broadly reactive immune response to all H5N1 influenza virus isolates. The optimized HA protein was developed through a series of HA protein alignments, and subsequent generation of consensus sequences, for clade 2 H5N1 influenza virus isolates. The final consensus HA amino acid sequence was reverse translated and optimized for expression in mammalian cells. Influenza virus-like particles containing the optimized HA protein are an effective vaccine against H5N1 influenza virus infection in animals.

Abstract: The invention relates to the use of an influenza antigen preparation obtainable by the following process, in the manufacture of an intradermal flu vaccine: (i) harvesting of virus-containing material from a culture; (ii) clarification of the harvested material to remove non-virus material; (iii) concentration of the harvested virus; (iv) a further step to separate whole virus from non-virus material; (v) splitting of the whole virus using a suitable splitting agent in a density gradient centrifugation step; (vi) filtration to remove undesired materials; wherein the steps are performed in that order but not necessarily consecutively.

Abstract: The invention provides a method of preventing the spreading of influenza viruses, and the factors making up the said method, and especially provides one type of combinatorial vaccine and the immunization method thereof. Two of more influenza vaccines are inoculated by a certain sequence, and each influenza vaccine vaccines is inoculated at least once, and the inoculation take place two or more times; wherein each influenza vaccine includes one or more antigens, the immunogenic fragments thereof, or the coding genes thereof, and further includes a different antigen, the immunogenic fragments or the coding gene of the different antigen.

Abstract: Influenza vaccines containing insoluble particulate adjuvants have been found to elicit an IgG response that is primarily a TH2 response (IgG1). This response can be shifted towards a TH1 response (IgG2a) by including immunopotentiators in the compositions. Thus the invention provides an immunogenic composition comprising: (i) an influenza virus antigen; (ii) an insoluble particulate adjuvant; and (iii) a immunopotentiator.

Abstract: The present invention provides, among other things, methods, reagents, and systems for the treatment, detection, analysis, and/or characterization of influenza infections.

Abstract: The present invention provides, in part, cochleate compositions and methods for making and using same.

Abstract: The present invention encompasses influenza vaccines, in particular avian influenza vaccines. The vaccine may be a subunit vaccine based on the hemagglutinin of influenza. The hemagglutinin may be expressed in plants including duckweed. The invention also encompasses recombinant vectors encoding and expressing influenza antigens, epitopes or immunogens which can be used to protect animals against influenza. It encompasses also a vaccination regimen compatible with the DIVA strategy, including a prime-boost scheme using vector and subunit vaccines.

Abstract: Immunogenic compositions comprise a RNA component and a polypeptide component. The RNA component is a self-replicating RNA. The polypeptide component comprises an epitope from an influenza virus antigen (the first epitope), and the RNA component encodes a polypeptide which also comprises an epitope from an influenza virus antigen (the second epitope). Delivery of epitopes in these two different manners can enhance the immune response to influenza virus as compared to immunization with the RNA or the polypeptide alone.

Abstract: The present invention discloses and claims virus like particles (VLPs) that express and/or contains seasonal influenza virus proteins, avian influenza virus proteins and/or influenza virus proteins from viruses with pandemic potential. The invention includes vector constructs comprising said proteins, cells comprising said constructs, formulations and vaccines comprising VLPs of the inventions. The invention also includes methods of making and administrating VLPs to vertebrates, including methods of inducing substantial immunity to either seasonal and avian influenza, or at least one symptom thereof.

Abstract: The present invention provides a recombinant soluble trimeric hemagglutinin (rHA) protein comprising a hemagglutinin ectodomain and an oligomerization domain. The rHA is produced as a soluble homotrimer, and may further comprises a signal peptide and/or an endoplasmic reticulum (ER) retention signal. The invention is also directed to nucleic acids encoding the rHA of the invention, as well as vectors and chimeric constructs comprising the nucleic acid. Methods of producing the rHA are also provided. The rHA described herein may be used to formulate influenza vaccines, or may be used to enrich existing vaccines.

Abstract: Immunogenic compositions comprising partially glycosylated viral glycoproteins for use as vaccines against viruses are provided. Vaccines formulated using mono-, di-, or tri-glycosylated viral surface glycoproteins and polypeptides provide potent and broad protection against viruses, even across strains. Pharmaceutical compositions comprising monoglycosylated hemagglutinin polypeptides and vaccines generated therefrom and methods of their use for prophylaxis or treatment of viral infections are disclosed. Methods and compositions are disclosed for influenza virus HA, NA and M2, RSV proteins F, G and SH, Dengue virus glycoproteins M or E, hepatitis C virus glycoprotein E1 or E2 and HIV glycoproteins gp120 and gp41.

Abstract: The invention relates to an expression system comprising polynucleotides encoding proteins, wherein the expression system comprises a first polynucleotide encoding at least one protein, peptide or variant thereof, which induces a T cell response, and a second polynucleotide encoding at least one protein peptide or variant thereof, which induces an anti-pathogenic B cell response. The invention further relates to protein mixtures encoded by the expression system and cells comprising the expression system or the protein mixture and pharmaceutical compositions comprising the expression system or the protein mixture. The expression system, polynucleotides, proteins, cells, and pharmaceutical compositions are useful in the prophylaxis or treatment of infections. The invention further relates to nucleotide constructs which comprises, essentially consists or consists of a polynucleotide encoding a modified influenza hemagglutinin (HA).

Abstract: The present invention provides an isolated canine influenza virus of subtype H3N8 comprising an HA having SEQ ID NO: 4 or an amino acid sequence that is greater than 99% identical to SEQ ID NO: 4, with the proviso that the amino acids at positions 94 and 233 are identical to SEQ ID NO: 4; a composition comprising attenuated or inactivated virus; isolated or purified HA, NM, NP, M1, NS1, PA, PB1, and PB2 proteins and fragments thereof and compositions comprising same or nucleic acids, optionally as part of a vector, encoding same; and a method of inducing an immune response to canine influenza virus in an animal comprising administering to the animal an aforementioned composition.