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: This disclosure provides recombinant respiratory syncytial virus (RSV) antigens and methods for making and using them, including immunogenic compositions (e.g., vaccines) for the treatment and/or prevention of RSV infection.

Abstract: This invention relates, e.g., to a virus-like particle (VLP) composition assembled from a chimeric polypeptide comprising a papilloma virus (e.g., human papillomavirus, or HPV) L1 major capsid protein, into which is inserted a surface-displayed peptide comprising a neutralizing epitope of a papillomavirus L2 protein. Vaccine compositions comprising the VLP are described, as well as methods for inducing an immune response (e.g., vaccinating) a subject against papilloma virus, using the VLP, and kits comprising the VLP, for carrying out a method of the invention.

Abstract: Chimeric alphaviruses and alphavirus replicon particles are provided, including methods of making and using same. Specifically, alphavirus particles are provided having nucleic acid molecules derived from one or more alphaviruses and structural proteins (capsid and/or envelope) from at least two or more alphaviruses. Methods of making, using, and therapeutic preparations containing the chimeric alphavirus particle, are disclosed.

Abstract: This disclosure provides novel human papillomavirus (HPV) protein constructs and their use in the prevention of HPV disease. The constructs are chimeric proteins comprising L1 proteins with an HPV L2 peptide inserted in to the L1 protein. Such chimeric proteins may be formulated into immunogenic e.g., vaccine compositions, and optionally formulated with HPV L1 VLP based vaccines.

Abstract: Compositions and methods for stimulating an immune response against Shiga toxin-producing Escherichia coli (STEC) antigens are disclosed. The compositions include a multiple epitope fusion protein comprising more than one epitope of an immunogenic STEC protein from more than one STEC serotype. Additional compositions include at least two purified STEC proteins, wherein the STEC proteins are selected from a full-length STEC protein, an immunogenic fragment or variant thereof, wherein at least one of the STEC proteins generates antibodies that react with STEC O157 and at least one other STEC serotype.

Abstract: The present invention relates to the construction, expression, and purification of synthetic or recombinant light chain (LC) botulinum neurotoxin genes from all botulinum neurotoxin serotypes. The methods of the invention can provide 1.1 g of the LC per liter of culture. The LC product is stable and proteolytically active. Methods of using the products of the invention are described.

Abstract: The invention relates to the use of proteins and peptides coded by the genome of the isolated or purified strain of severe acute respiratory syndrome (SARS)-associated coronavirus, resulting from sample reference number 031589 and, in particular, to the use of protein S and the derivative antibodies thereof as diagnostic reagents and as a vaccine.

Abstract: The invention provides protective antigens for Group B streptococcus hypervirulent strains. The fragments are useful in vaccine compositions to induce protection against S. agalactiae, particularly against hypervirulent strains.

Abstract: The invention provides compositions, methods, and kits for the treatment or prevention of viral infections. The polyvalent (e.g., 2-valent) vaccines described herein incorporate computationally-optimized viral polypeptides that can increase the diversity or breadth and depth of cellular immune response in vaccinated subjects.

Abstract: Disclosed herein are compositions and methods for eliciting immune responses against antigens. In particular embodiments, the compounds and methods elicit immune responses against antigens that are otherwise recognized by the host as “self” antigens. The immune response is enhanced by presenting the host immune system with a chimeric antigen comprising an immune response domain and a target binding domain, wherein the target binding domain comprises a xenotypic antibody fragment. By virtue of the target binding domain, antigen presenting cells take up, process, and present the chimeric antigen, eliciting both a humoral and cellular immune response.

Abstract: The invention relates to polypeptide carrier proteins that comprise at least five CD4+ T cell epitopes, for conjugation to capsular polysaccharides. The carrier proteins are useful as components of vaccines that can elicit a T-cell dependent immune response. These vaccines are particularly useful to confer protection against infection from encapsulated bacteria in infants between the ages of 3 months and about 2 years.

Abstract: The present invention provides an export signal system based on E. coli CS3 antigen for directing the secretion of foreign antigens from host cells. In particular, the invention describes genetic constructs encoding fusion proteins that contain a CS3 export signal fused to at least one heterologous amino acid sequence. Attenuated microorganisms expressing the fusion proteins and pharmaceutical compositions comprising such attenuated microorganisms are also disclosed.

Abstract: The invention provides compositions and fusion proteins comprising a flagellin adjuvant and a Pseudomonas aeruginosa antigen. The invention further provides pharmaceutical formulations and methods for inducing an immune response against P. aeruginosa (e.g., to prevent and/or treat P. aeruginosa infection).

Abstract: The invention relates to, in part, secreted proteins of bacterial pathogens and methods for their use. More specifically, the invention provides in part several new common secreted proteins for A/E pathogens. In some embodiments of the invention, these polypeptides and nucleic acid molecules encoding these polypeptides, or portions thereof, are useful as vaccines, diagnostics, or drug screening tools for A/E pathogenic infections, or as reagents.

Abstract: The present invention relates to methods of producing a heterologous biological substance, comprising: (a) cultivating a mutant of a parent Bacillus cell under conditions conducive for the production of the heterologous biological substance, wherein (i) the mutant cell comprises a first nucleic acid sequence directing synthesis of the heterologous biological substance and a second nucleic acid sequence comprising a modification of at least one of the genes cypX and yvmC, which are involved in the production of a red pigment, and (ii) the mutant cell is deficient in the production of the red pigment compared to the parent Bacillus cell when cultivated under the same conditions; and (b) recovering the heterologous biological substance from the cultivation medium. The present invention also relates to mutants of Bacillus cells and methods for producing the mutants.

Abstract: A polynucleotide sequence is provided comprising a nucleic acid sequence encoding recombinant Protective Antigen (rPA). Also provided are expression vectors and host cells comprising the polynucleotide sequence of the invention, and methods for producing rPA.

Abstract: The present invention relates to isolated nucleic acid molecules which encode an antigen from a nontypable Haemophilus influenzae (H. influenzae) species, a vector which comprises such nucleic acid molecule, and a host cell comprising such vector. Furthermore, the invention provides antigens from a nontypable Haemophilus influenzae species, as well as fragments and variants thereof, a process for producing such antigens, and a process for producing a cell, which expresses such antigen. More specifically such antigens are produced by or associated with bacterial infections caused by nontypable Haemophilus influenzae.

Abstract: Cloning and expression of genes encoding C. parvum antigenic polypeptides are described as are antibodies that recognize epitopes on these polypeptides. The antigenic polypeptides and antibodies thereto can be used in therapeutic compositions for the prevention and treatment of C. parvum infections, as well as in diagnostic methods for determining the presence of C. parvum infections.

Abstract: HBsAg is expressed in a Saccharomyces cerevisiae host, carrying a plasmid having a HBsAg coding sequence, wherein the plasmid includes: (1) an upstream promoter from a glyceraldehyde-3-phosphate dehydrogenase gene, for controlling expression of the HBsAg coding sequence; and (2) an ARG3 transcription terminator downstream of the HBsAg coding sequence. The plasmids may also include: (3) a LEU2 selection marker; (4) a 2? plasmid sequence; and (5) an origin of replication functional in Escherichia coli. HBsAg can be expressed in this host, and can be purified for use in the manufacture of vaccines, and in particular for the manufacture of combination vaccines and in new monovalent HBV vaccines e.g. with non-alum adjuvants.

Abstract: The present invention relates to a permanent human cell line comprising a nucleic acid sequence for the adenoviral gene functions E1A and E1B and the nucleic acid sequence for the SV40 large T-antigen or the Epstein-Barr virus (EBV) nuclear antigen 1 (EBNA-1). Further, the present invention relates to a method for transient expression of recombinant polypeptides and proteins in said permanent human cell line.

Abstract: The present invention discloses amino acid sequences and nucleic acid sequences relating to a Streptococcus pneumoniae surface associated Pneumo Protective Protein (PPP) having a molecular weight of about 20 kilo Daltons (kDa). The PPP exhibits the ability to reduce colonization of pneumococcal bacteria. Thus the present invention also pertains to compositions for the treatment and prophylaxis of infection or inflammation associated with bacterial infection.

Abstract: EphA2 T-cell epitope are provided herein. The epitopes include peptides corresponding to specific fragments of human EphA2 protein containing one or more T-cell epitopes, and conservative derivatives thereof. The EphA2 T-cell epitopes are useful in an assay, such as an ELISPOT assay, that may be used to determine and/or quantify a patient's immune responsiveness to EphA2. The epitopes also are useful in methods of modulating a patient's immune reactivity to EphA2, which has substantial utility as a treatment for cancers that overexpress EphA2, such as renal cell carcinoma (RCC). The EphA2 epitopes also can be used to vaccinate a patient against EphA2, by in vivo or ex vivo methods.

Abstract: The present invention relates to Neisseria ORF2086 proteins, crossreactive immunogenic proteins which can be isolated from nesserial strains or prepared recombinantly, including immunogenic portions thereof, biological equivalents thereof, antibodies that immunospecifically bind to the foregoing and nucleic acid sequences encoding each of the foregoing, as well as the use of same in immunogenic compositions that are effective against infection by Neisseria meningitidis serogroup B.

Abstract: The invention provides protective antigens which are useful in vaccine compositions to induce protection against gram positive bacteria, particularly against S. agalactiae, S. pyogenes, S. pneumoniae, S. aureus, S. suis, and S. equi.

Abstract: The present invention relates to the intersection of the fields of immunology and protein engineering, and particularly to antigens and compositions useful in inducing or enhancing an immune response agains influenza antigens. Provided are recombinant protein antigens, compositions, and methods for the production of such antigens in plants. In some embodiments, influenza antigens include hemagglutinin polypeptides, neuraminidase polypeptides, and/or combinations thereof.

Abstract: The invention provides HSV antigens that are useful for the prevention and treatment of HSV infection. Disclosed herein are epitopes confirmed to be recognized by T-cells derived from herpetic lesions. T-cells having specificity for antigens of the invention have demonstrated cytotoxic activity against cells loaded with virally-encoded peptide epitopes, and in many cases, against cells infected with HSV, The identification of immunogenic antigens responsible for T-cell specificity provides improved anti-viral therapeutic and prophylactic strategies. Compositions containing antigens or polynucleotides encoding antigens of the invention provide effectively targeted vaccines for prevention and treatment of HSV infection.

Abstract: The invention provides a method for the expression and subsequent screening of DNA libraries, particularly synthetic, genomic, and cDNA libraries, in filamentous fungal hosts. In particular, the invention provides vectors, host strains, and a method for the expression and screening of complex DNA libraries, including, but not limited to, combinatory (combinatorial) libraries expressing one, two or more variable constituents and/or prepared from two or more sublibraries (e.g., for the expression and screening of immunoglobulin (including fragments and derivatives of whole immunoglobulin proteins) and other receptor or complex DNA libraries or libraries of libraries). The invention is useful for the expression and screening for a large variety of proteins and protein complexes, including human proteins. The present invention also relates to novel fungal protease sequences.

Abstract: The invention relates to the development of chimeric OspA molecules for use in a new Lyme vaccine. More specifically, the chimeric OspA molecules comprise the proximal portion from one OspA serotype, together with the distal portion from another OspA serotype, while retaining antigenic properties of both of the parent polypeptides. The chimeric OspA molecules are delivered alone or in combination to provide protection against a variety of Borrelia genospecies. The invention also provides methods for administering the chimeric OspA molecules to a subject in the prevention and treatment of Lyme disease or borreliosis.

Abstract: The subject invention provides novel Plasmodium falciparum antigens and novel polynucleotides encoding these antigens. Also provided by the subject invention are methods of using these antigens and polynucleotides.

Abstract: Objective methods for detecting and diagnosing bladder cancer (BLC) are described herein. In one embodiment, the diagnostic method involves determining the expression level of a BLC-associated gene that discriminates between BLC cells and normal cells. The present invention further provides means for predicting and preventing bladder cancer metastasis using BLC-associated genes having unique altered expression patterns in bladder cancer cells with lymph-node metastasis. Finally, the present invention provides methods of screening for therapeutic agents useful in the treatment of bladder cancer, methods of treating bladder cancer and method for vaccinating a subject against bladder cancer. In particular, the present application provides novel human genes C2093, B5860Ns and C6055s whose expression is markedly elevated in bladder cancers.

Abstract: Provided herein are isolated genomic polynucleotide fragments from the p15 arm of chromosome 11 and methods of use.

Abstract: A recombinant avian infectious coryza vaccine and a process for preparing the same are provided. A process for preparing a recombinant avian infectious coryza vaccine which comprises step of constructing E. coli that may produce as an inclusion body a fusion peptide consisting of peptides derived from outer-membrane protein of Avibacterium paragarinarum serotype A and serotype C, step of culturing said E. coli and colleting and purifying inclusion body from culture, and step of preparing a preparation comprising said purified inclusion body, and an avian infectious coryza vaccine comprising as an active ingredient the fusion peptide. A linker sequence may be inserted between the respective peptides comprising the fusion peptide. For the peptide derived from the serotypes A and C, an amino acid sequence region of Region 2 or its vicinity responsible for protection from infection may be used.

Abstract: The present invention provides methods of isolation and purification of Streptomyces griseus trypsin (SGT) from PRONASE protease mixture in a single affinity chromatography step and uses of the purified SGT.

Abstract: The present invention relates to a cell line selected from the group consisting of (a) a cell line denominated NM-F9 having the DSMZ accession number DSM ACC2606; (b) a cell line denominated NM-D4 having the DSMZ accession number DSM ACC2605; and subclones of (a) or (b). Additionally, the present invention provides a lysate of the cell lines or a molecule or mixture of molecules obtained from these cell lines as well as dendritic cells loaded with said lysate, co-cultivated or fused with cells from the cell lines, or a molecule or mixture of molecules obtained from these cell lines of the present invention. Moreover compositions, preferably pharmaceutical or vaccine compositions are provided which comprise the cell lines, lysate, molecules, mixture of molecules or dendritic cells of the present invention. In another aspect the present invention relates to methods for producing the aforementioned compositions.

Abstract: Tat protein produced in bulk culture is inactive when induced at conventional optical densities but can be obtained in biologically active form when induced during the logarithmic growth phase.

Abstract: The present invention relates to the intersection of the fields of immunology and protein engineering, and particularly to antigens and vaccines useful in prevention of infection by Plasmodium parasites. Provided are recombinant protein antigens, compositions, and methods for the production of such antigens in plants. In some embodiments, Plasmodium antigens include Pfs25 polypeptides, Pfs28 polypeptides, Pfs48/45 polypeptides, Pfs230 polypeptides, and/or combinations thereof.

Abstract: Disclosed are a construct for expressing a rotavirus antigen complex loaded with a heterologous virus epitope, a vaccine composition containing the rotavirus antigen complex, a virus-like particle of rotavirus containing the rotavirus antigen complex, and a vaccine composition containing the virus-like particle of rotavirus. According to the present disclosure, an antigen complex containing a rotavirus antigen as well as a heterologous virus epitope and a virus-like particle of rotavirus containing the antigen complex can be produced in large scale at low cost. Thus, the present disclosure may be applied for research and development of novel complex vaccines for rotavirus and heterologous virus.

Abstract: Disclosed are methods, compositions, zona pellucida binding peptides and polypeptides, and expression vectors for use in species-specific immunocontraception of animals, which include landscape bacteriophage. The disclosed compositions may include immunogenic compositions or vaccines.

Abstract: The invention relates to novel insertion sites useful for the integration of HIV DNA sequences into the MVA genome, and to the resulting recombinant MVA derivatives.

Abstract: A fusion protein comprising an antigenic fragment of apoB-100 and a suitable carrier and related compositions methods and systems.

Abstract: A plant-derived vaccine against respiratory syncytial virus (RSV) is disclosed. The vaccine includes an immunogenic complex that includes plant cells transformed with a chimeric gene containing a nucleotide sequence adapted for protein expression in plants and an RSV coding sequence that encodes an antigenic protein of RSV. Also disclosed are methods of making the plant-derived vaccine of the invention, as well as transgenic plants, transgenic plant cells, and nucleic acid constructs useful in immunizing a mammal against RSV.

Abstract: The invention relates to a method for preparation of soluble N-protein/truncated P-protein complex of a virus of the family Paramyxoviridae, complexes prepared thus and the soluble N-proteins which may be isolated from said complexes. The invention further relates to vaccine compositions comprising said N-protein/truncated P-protein complexes or N-proteins from Paramyxoviridae.

Abstract: The invention provides a method of identifying an antigen that is present in different amounts in two different samples. In general, the methods involve generating a first and second distinguishably labeled population of antibodies that reactive to the two samples, contacting the first and second labeled populations of antibodies with a plurality of antigens; and identifying any resultant antigens that are differentially bound by the first and second populations of antibodies. The antigens may be on the surface of cells e.g., animal cells, or on a solid support. Once identified, the nucleic acid encoding an antigen of interest may be identified and sequenced to reveal the identity of the antigen of interest. Kits for performing the methods are also provided. The methods find most use in medical and research applications, in particular, for identifying cell surface targets for immunotherapy and drug discovery.

Abstract: The invention relates to the development of chimeric OspA molecules for use in a new Lyme vaccine. More specifically, the chimeric OspA molecules comprise the proximal portion from one OspA serotype, together with the distal portion from another OspA serotype, while retaining antigenic properties of both of the parent polypeptides. The chimeric OspA molecules are delivered alone or in combination to provide protection against a variety of Borrelia genospecies. The invention also provides methods for administering the chimeric OspA molecules to a subject in the prevention and treatment of Lyme disease or borreliosis.

Abstract: The present invention concerns a method for producing a recombinant Dermatophagoides pteronyssinus 2 protein (rDer p 2), comprising the steps of cultivating a Pichia pastoris yeast strain previously transformed with a rDer p 2 coding sequence, and isolating the rDer p 2 protein from said Pichia pastoris yeast strain. The invention also relates to compositions and kits comprising the rDer p 2 protein for therapeutic or diagnostic use.

Abstract: The present invention relates to an animal vaccine directed to progressive atrophic rhinitis (PAR), comprising at least two fragments of recombinant subunit Pasteurella multocida toxins (rsPMT) capable of eliciting the production of antibodies against Pasteurella multocida associated with PAR, and to a method for producing the animal vaccine of the invention, said fragments each having an amino acid sequence that substantially corresponds to the 2-486, 486-986 or 986-1281 amino acid residues of Pasteurella multocida toxin (PMT), respectively. Also disclosed is a multivalent animal vaccine, comprising said fragments as active components against PAR, and at least a pathogenic antigen or epitope thereof associated with other animal disease(s), such as inactivated gE-deleted Pseudorabies virus.

Abstract: The invention provides a novel surface polypeptide from Neisseria meningitidis as well as nucleic acid and nucleic acid sequence homologues encoding this protein. Pharmaceutical compositions containing the polypeptide and nucleic acids of the invention are also disclosed as well as methods useful in the treatment, prevention and diagnosis of N. meningitidis infection.

Abstract: The present invention relates to genetically attenuated superantigen toxin vaccines altered such that superantigen attributes are absent, however the superantigen is effectively recognized and an appropriate immune response is produced. The attenuated superantigen toxins are shown to protect animals against challenge with wild type toxin. Methods of producing and using the altered superantigen toxins are described.

Abstract: The invention provides HSV antigens that are useful for the prevention and treatment of HSV infection. Disclosed herein are antigens and/or their constituent epitopes confirmed to be recognized by T-cells derived from herpetic lesions or from uterine cervix. T-cells having specificity for antigens of the invention have demonstrated cytotoxic activity against cells loaded with virally-encoded peptide epitopes, and in many cases, against cells infected with HSV. The identification of immunogenic antigens responsible for T-cell specificity provides improved anti-viral therapeutic and prophylactic strategies. Compositions containing antigens or polynucleotides encoding antigens of the invention provide effectively targeted vaccines for prevention and treatment of HSV infection.