Abstract: A dry powder norovirus vaccine is provided, which comprises at least two norovirus antigens representing different genogroups. The vaccine may be produced by formulation with a mixture of different antigens or combination of monovalent powders with each containing one antigen. The formulated vaccine is suitable for mucosal administration and soluble in aqueous solutions for parenteral administration. A method of immunization is also provided, which comprises at least one administration of the vaccine via mucosal and/or parental route. The immunization may have multiple administrations of the vaccine, i.e., one or more immunizations via a mucosal route followed by one or more immunizations via a parenteral route or vice versa, to maximize both mucosal and systemic immune responses and protection against norovirus infections.

Abstract: The present invention provides new feline calicivirus vaccines, including multivalent vaccines. The present invention also provides methods of making and using the vaccines.

Abstract: The present invention provides new multivalent vaccines for felines. The present invention also provides methods of making and using the multivalent vaccines alone or in combinations with other protective agents.

Abstract: Methods of purifying virus-like particles (VLPs) that are substantially free of process contaminants and infectious agents. The methods incorporate, for example, low-pH treatment during harvest and/or inactivation by a solvent and/or detergent during VLP capture.

Abstract: The present disclosure relates to a polymer-coated virus particle for an oral virus vaccine, a method of preparing the same, and a composition comprising the same. In accordance with the present disclosure, the oral virus vaccine can be effectively delivered to the intestines without being destroyed even in the low pH environment of the gastrointestinal tract, then the prevention efficacy against viral infections can be improved.

Abstract: The present invention relates to vaccine compositions comprising Norovirus antigens and adjuvants, in particular, mixtures of monovalent VLPs and mixtures of multivalent VLPs, and to methods of conferring protective immunity to Norovirus infections in a human subject.

Abstract: The present invention aims at establishing a novel means for purifying norovirus VLPs. There is provided a purification method of norovirus virus-like particles, comprising: contacting solution containing norovirus virus-like particles with support for hydroxyapatite chromatography, binding the virus-like particles to the support, subsequently washing the support with buffer, and then eluting the virus-like particles from the support with buffer containing phosphate, wherein the phosphate concentration of the buffer used for elution is less than 10 mM.

Abstract: The invention relates to a method for purifying compositions containing virus-like particles (VLP), wherein a VLP-containing composition is filtered through a filter medium, in particular through a membrane, having a molecular weight cut off (MWCO) of more than 30 kDa, and the cell culture supernatant of VLP-expressing cells is used as a VLP-containing composition. The invention further relates to a VLP-containing composition which can be produced by this method.

Abstract: The present invention relates to, inter alia, a method of raising an immune response against a pathogen which comprises administering (i) one or more first immunogenic polypeptides derived from said pathogen; (ii) one or more adenoviral vectors comprising one or more heterologous polynucleotides encoding one or more second immunogenic polypeptides derived from said pathogen; and (iii) an adjuvant; wherein the one or more first immunogenic polypeptides, the one or more adenoviral vectors and the adjuvant are administered concomitantly. The invention also relates to vaccines, pharmaceutical compositions, kits and uses employing said polypeptides, adenoviral vectors and adjuvants.

Abstract: The present invention relates generally to glutamine-free cell culture media supplemented with asparagine. The invention further concerns the production of recombinant proteins, such as antibodies, in asparagine-supplemented glutamine-free mammalian cell culture.

Abstract: An adjuvant composition which comprises an anionic macromolecule component particularly an ionic polysaccharide such as DEAE-dextran, and a saponin component, particularly an immunostimulating complex component. Immunogenic compositions comprising an immunogen and this adjuvant composition are also disclosed together with methods of use thereof.

Abstract: Immunogenic compositions that elicit immune responses against Norovirus and Sapovirus antigens are described. In particular, the invention relates to polynucleotides encoding one or more capsid proteins or other immunogenic viral polypeptides from one or more strains of Norovirus and/or Sapovirus, coexpression of such immunogenic viral polypeptides with adjuvants, and methods of using the polynucleotides in applications including immunization and production of immunogenic viral polypeptides and viral-like particles (VLPs). Methods for producing Norovirus- or Sapovirus-derived multiple epitope fusion antigens or polyproteins and immunogenic compositions comprising one or more immunogenic polypeptides, polynucleotides, VLPs, and/or adjuvants are also described.

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: 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: An optimized baculovirus/insect cell-mediated system is provided for the production of enterovirus 71 virus-like particles to produce a vaccine against recent EV71 virus outbreaks. Co-expression of the viral capsid polyprotein P1 ORF derived from a fatal case in the Fuyang province of the People's Republic of China plus the 3 CD protease of EV71 prototype strain BrCr resulted in the formation of VLPs. The yields were increased by co-expression of both P1 and 3CD in separate transgene cassettes arranged in opposite orientation in a bicistronic baculovirus vector and by inserting the translational enhancing signal L21 in front of the capsid protein open reading frame. Faster transgene processing was achieved by using insect Sf21 cells instead of Sf9 cells.

Abstract: The present invention relates to methods and compositions for use in inducing tumor-specific antibody mediated complement-dependent cytotoxic response in an animal having a tumor comprising administering to said animal a composition comprising a replication competent oncolytic virus wherein administration of the composition induces in the animal production of antibodies that mediate a CDC response specific to said tumor.

Abstract: The present invention provides polypeptides having a composite amino acid sequence derived from a consensus sequence representing the capsid proteins of two or more circulating strains of a non-enveloped virus. In particular, the invention provides virus-like particles comprising at least one composite polypeptide. Such virus-like particles have antigenic epitopes of two or more circulating strains of a non-enveloped virus and produce an increase in antisera cross-reactivity to one or more circulating strains of the non-enveloped virus. Methods of making composite virus-like particles and vaccine formulations comprising composite virus-like particles are also disclosed.

Abstract: The present invention relates to a combined norovirus and rotavirus vaccine for prevention of norovirus and rotavirus infection and/or viral-induced diarrheal and vomiting diseases in man. More specifically, the invention comprises a method of preparing combination vaccine compositions comprising norovirus and rotavirus antigens, in particular mixtures of norovirus VLPs and rotavirus recombinant VP6 protein or double-layered VP2/VP6 VLPs. In addition, the invention relates to methods of inducing an immune response.

Abstract: The invention provides isolated fully human monoclonal anti-HRV antibodies, as well as method of making and using these antibodies. Anti-HRV antibodies of the invention prevent or treat subjects having HRV-infections, and related diseases, including, but not limited to, the common cold, nasopharyngitis, croup, pneumonia, bronchiolitis, asthma, chronic obstructive pulmonary disease (COPD), sinusitis, bacterial superinfection, and cystic fibrosis.

Abstract: The invention provides isolated fully human monoclonal anti-HRV antibodies, as well as method of making and using these antibodies. Anti-HRV antibodies of the invention prevent or treat subjects having HRV-infections, and related diseases, including, but not limited to, the common cold, nasopharyngitis, croup, pneumonia, bronchiolitis, asthma, chronic obstructive pulmonary disease (COPD), sinusitis, bacterial superinfection, and cystic fibrosis.

Abstract: Previously we have identified a conserved domain (SAP, for SAF-A/B, Acinus, and PIAS) in the foot-and-mouth disease virus (FMDV) leader (L) protein coding region that is required for proper sub-cellular localization and function. Mutation of isoleucine 55 and leucine 58 to alanine (I55A, L58A) within the SAP domain resulted in a viable virus that displayed a mild attenuated phenotype in cell culture, along with altered sub-cellular distribution of L and failure to induce degradation of the transcription factor nuclear factor kappa-B. Here we report that inoculation of swine and cattle with this mutant virus results in the absence of clinical disease, the induction of a significant FMDV-specific neutralizing antibody response, and protection against subsequent homologous virus challenge. Remarkably, swine vaccinated with SAP mutant virus are protected against wild type virus challenge as early as two days post-vaccination suggesting that a strong innate as well as adaptive immunity is elicited.

Abstract: The present invention relates to antigenic and vaccine compositions comprising Norovirus antigens and adjuvants, in particular, mixtures of monovalent VLPs and mixtures of multivalent VLPs, and to a process for the production of both monovalent and multivalent VLPs, the VLPs comprising capsid proteins from one or more Norovirus genogroups.

Abstract: The present invention pertains to a method for keeping a foot-and-mouth disease vaccine available for emergency vaccination of animals against foot-and-mouth disease, the vaccine comprising a foot-and-mouth disease antigen formulated in a water-in-oil emulsion, the method comprising the steps of providing the formulated vaccine, freezing the vaccine, and storing the frozen vaccine until it is needed for emergency vaccination.

Abstract: The present invention provides methods and compositions comprising a chimeric norovirus capsid protein comprising a norovirus VP1 major capsid protein backbone comprising a norovirus epitope selected from the group consisting of: a) Epitope A; b) Epitope B; c) Epitope C; d) Epitope D; e) Epitope E; f) Epitope F; and g) any combination of (a) through (f) above, wherein the norovirus epitope is from a norovirus strain that is different from the norovirus VP1 major capsid protein backbone.

Abstract: The invention is directed to a vaccine comprising: i) coxsackie B virus CBV1 and CBV2, and ii) at least one coxsackie B virus selected from CBV3, CBV4, CBV5 and CBV6. The CBVs are present in the vaccine in inactivated form, in the form of a component of the virus or as an antibody against the virus. The vaccine is effective in preventing and treating type 1 diabetes. So is an anti-coxsackie B virus composition provided.

Abstract: The present invention provides a foot-and-mouth diseases virus (FMDV) VP1 capsid protein which comprises an entity of interest (EOI). The EOI sequence may, for example, be an epitope tag, an immunomodulatory molecule or a target molecule. The present invention also provides an FMDV vaccine which comprises such a VP1 capsid protein and its use to prevent FMD.

Abstract: The present invention relates to immunostimulatory oligodeoxynucleotides, vectors and vaccines comprising such oligodeoxynucleotides, to their use as a medicament, to their use in preventing or combating infectious disease and to methods for the detection of such oligodeoxynucleotides.

Abstract: We have generated novel molecularly marked FMDV A24LL3DYR and A24LL3BPVKV3DYR vaccine candidates. The mutant viruses contain a deletion of the leader coding region (LL) rendering the virus attenuated in vivo and negative antigenic markers introduced in one or both of the viral non-structural 3Dpol and 3B proteins. The vaccine platform includes unique restriction endonuclease sites for easy swapping of capsid proteins for different FMDV subtypes and serotypes. The mutant viruses produced no signs of FMD and no shedding of virulent virus in cattle. No clinical signs of disease or fever were observed and no transmission to in-contact animals was detected in pigs inoculated with live A24LL3DYR. Cattle immunized with chemically inactivated vaccine candidates showed an efficacy comparable to a polyvalent commercial FMDV vaccine. These vaccine candidates used in conjunction with a cELISA provide a suitable target for DIVA companion tests.

Abstract: A method for producing picornaviral capsid protein complexes (e.g., picornavirus like particles) in E. coli using a small-ubiquitin-related fusion protein expression system and an E. coli strain used in practicing this method. Also disclosed is use of the picornaviral capsid protein complexes like thus prepared for eliciting immune responses.

Abstract: There is a disclosed a method of killing abnormal cells such as malignant cells including melanoma cells, using a virus recognising at least one of a cell adhesion molecule and a complement regulatory protein. The virus may be a member of the Picornaviridae family. Coxsackie A-group viruses have been found to be particularly suitable. The cell adhesion molecule is desirably a member of the immunoglobulin (Ig) superfamily. Typically, the complement regulatory protein will be DAF.

Abstract: The present invention relates to a novel, isolated and purified hemorrhagic feline calicivirus FCV-DD1. The invention further embraces monovalent and multivalent vaccines containing the new FCV-DD1 strain. In addition, the invention encompasses methods of protecting felines against infection or preventing disease caused by feline calicivirus alone or in addition to other pathogens that comprises administering to the felines an immunologically effective amount of the monovalent and multivalent vaccines described herein. Also, the invention concerns methods for diagnosing or detecting the hemorrhagic feline calicivirus in a susceptible host, asymptomatic carrier and the like by detecting the presence of feline calicivirus FCV-DD1 or antibodies raised or produced against feline calicivirus FCV-DD1 antigen.

Abstract: A method for eliciting an immune response by contacting a mucosal surface utilizing a composition including an antigen, a NOD agonist, and a mucoadhesive, wherein the NOD agonist is N-Acetyl-muramyl-L-Alanyl-D-Glutamin-n-butyl-ester (“Murabutide”).

Abstract: A method for producing picornaviral capsid protein complexes (e.g., picornavirus like particles) in E. coli using a small-ubiquitin-related fusion protein expression system and an E. coli strain used in practicing this method. Also disclosed is use of the picornaviral capsid protein complexes like thus prepared for eliciting immune responses.

Abstract: Methods for purifying human Calciviruses are disclosed, including Noroviruses and Sapoviruses.

Abstract: The present invention relates to antigenic and vaccine compositions comprising Norovirus antigens and adjuvants, in particular, mixtures of monovalent VLPs and mixtures of multivalent VLPs, and to a process for the production of both monovalent and multivalent VLPs, the VLPs comprising capsid proteins from one or more Norovirus genogroups.

Abstract: The present invention relates to vaccine compositions comprising Norovirus antigens and adjuvants, in particular, mixtures of monovalent VLPs and mixtures of multivalent VLPs, and to methods of conferring protective immunity to Norovirus infections in a human subject.

Abstract: The present invention relates to antigenic and vaccine compositions comprising Norovirus antigens and adjuvants, in particular, mixtures of monovalent VLPs and mixtures of multivalent VLPs, and to a process for the production of both monovalent and multivalent VLPs, the VLPs comprising capsid proteins from one or more Norovirus genogroups.

Abstract: The present invention pertains to the field of immunology and genetic engineering. In particular, the present invention relates to the construction, preparation and use of a recombinant vaccine against foot-and-mouth disease virus. The vaccine comprises a tandem repeat of an antigenic epitope of FMDV VP1 protein, the constant region of the immunoglobulin heavy chain or a functional fragment thereof, and the FMDV 3D protein or an immunogenic fragment thereof. The vaccine can induce protective immune response against FMDV in an animal.

Abstract: A substituted Norovirus capsid protein monomer, having only the P-domain and called an antigen-Norovirus P-domain monomer, includes a foreign antigen inserted into one or more of three surface loops present on each P-domain monomer by molecular cloning. The antigen-P-domain monomer can assemble spontaneously into an octahedral form, called an antigen-Norovirus P-particle, that is composed of 24 copies of the antigen-P-domain monomer. Each substituted P-domain monomer will contain one to three copies of the foreign antigen, for a total of 24-72 antigen copies on each antigen-P-particle. The antigen-P-particle is useful in methods for diagnosing, immunizing and treating individuals infected with a foreign virus, for example Rotavirus, and can serve as a carrier for presentation of foreign antigens for development of novel vaccines against many infectious and non-infectious diseases. The substituted Norovirus P-particles can be readily produced in E.

Abstract: Methods for purifying human Calciviruses are disclosed, including Noroviruses and Sapoviruses.

Abstract: The invention is directed to a Feline Picorna Virus, an isolated nucleic acid and amino acid sequences therefrom, and uses thereof.

Abstract: The present invention relates to oncolytic Picornaviruses and methods and compositions for treating subjects having hematologic cancers. These include methods and compositions for treatment of myeloma, using disclosed Picornavirus such as Coxsackievirus, in methods of direct or indirect administration to subjects and ex vivo purging of malignant cells within auto grafts prior to transplantation.

Abstract: Use of an ubiquitination pathway-related factor, its agonist or antagonist in the preparation of a composition for regulating FOXP3, IL-2, and/or IFN-? activity, in which the ubiquitination pathway-related factor is selected from: Toll-like receptor, ubiquitin ligase, pro-inflammatory cytokine family receptor, and/or its coding sequence. The new type of regulatory factors can regulate regulatory T cells and immune system by regulating FOXP3, IL-2, and/or IFN-? activity. The regulatory factors and their derivatives can also be used as immunoadjuvant for treating or preventing major diseases (such as, infectious diseases and tumor, etc).

Abstract: The present invention relates to immunogenic compositions comprising a dried solid or highly viscous liquid formulation of inactivated polio virus (IPV) and a stabilizing agent wherein the IPV retains its antigenicity and/or immunogenicity. Methods of producing a dried formulation of IPV which retains its antigenicity/immunogenicity are described.

Abstract: The invention provides isolated fully human monoclonal anti-HRV antibodies, as well as method of making and using these antibodies. Anti-HRV antibodies of the invention prevent or treat subjects having HRV-infections, and related diseases, including, but not limited to, the common cold, nasopharyngitis, croup, pneumonia, bronchiolitis, asthma, chronic obstructive pulmonary disease (COPD), sinusitis, bacterial superinfection, and cystic fibrosis.

Abstract: A polynucleotide base sequence represented by SEQ ID NO: 22, a vector containing the polynucleotide and a method of preparing a small round structure virus (SRSV) virus-like particle in insect cells with vector.

Abstract: We have generated novel molecularly marked FMDV A24LL3DYR and A24LL3BPVKV3DYR vaccine candidates. The mutant viruses contain a deletion of the leader coding region (LL) rendering the virus attenuated in vivo and negative antigenic markers introduced in one or both of the viral non-structural 3Dpol and 3B proteins. The vaccine platform includes unique restriction endonuclease sites for easy swapping of capsid proteins for different FMDV subtypes and serotypes. The mutant viruses produced no signs of FMD and no shedding of virulent virus in cattle. No clinical signs of disease or fever were observed and no transmission to in-contact animals was detected in pigs inoculated with live A24LL3DYR. Cattle immunized with chemically inactivated vaccine candidates showed an efficacy comparable to a polyvalent commercial FMDV vaccine. These vaccine candidates used in conjunction with a cELISA provide a suitable target for DIVA companion tests.

Abstract: The invention is directed to an adenoviral vector comprising at least one nucleic acid sequence encoding an aphthovirus antigen and/or a cytokine operably linked to a promoter. The adenoviral vector is replication-deficient and requires at most complementation of both the E1 region and the E4 region of the adenoviral genome for propagation. The invention also is directed to a method of inducing an immune response in a mammal comprising administering to the mammal a composition comprising the aforementioned adenoviral vector.

Abstract: Provided herein is a nucleic acid comprising consensus amino acid sequence of foot-and-mouth disease FMDV VP1-4 coat proteins of FMDV subtypes A, Asia 1, C, O, SAT1, SAT2, and SAT3 as well as plasmids and vaccines expressing the sequences. Also provided herein is methods for generating an immune response against one or more FMDV subtypes using the vaccine as described above as well as methods for deciphering between vaccinated mammals with the vaccine and those that are infected with FMDV.

Abstract: Norovirus capsid protein monomers having only the P domain, and not the hinge or S domain, can assemble spontaneously into an icosahedral form herein called the P-particle. Factors affecting the formation and stability of the P-particle, as well as providing methods for diagnosing and treating Norovirus-infected individuals and creating a vaccine for prevention of Norovirus infection are presented.