US2012020964A1PendingUtilityA1

Antibodies for Norovirus

Assignee: FRYE JANE CATHERINEPriority: Jun 30, 2006Filed: Oct 5, 2011Published: Jan 26, 2012
Est. expiryJun 30, 2026(expired)· nominal 20-yr term from priority
A61K 2039/53A61P 37/00G01N 33/56983A61K 39/12A61K 2039/55516Y10S435/975C12N 2770/16022C12N 2770/16034A61K 2039/6081C07K 14/005A61P 37/04G01N 2333/08A61P 31/14A61P 31/12A61K 39/00C07K 16/10A61K 39/125C07K 16/106
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Claims

Abstract

Norovirus antigen peptides are described having an amino acid sequence selected from the group consisting of SEQ ID NOS: 1-16, or fragments thereof. Such peptides can be used in the preparation of antiviral therapies such as vaccines, methods of preparing antibodies to the antigen peptides, methods of using the peptides or the corresponding antibodies for detection of norovirus, and compositions of the peptides, DNA and/or antibodies. A kit for the detection of norovirus is also provided.

Claims

exact text as granted — not AI-modified
1 . An immunogen comprising an antigen peptide having an amino acid sequence selected from the group consisting of SEQ ID NOS:1-16, or a fragment thereof, wherein the fragment comprises at least 4 continuous amino acid residues. 
     
     
         2 . A composition comprising the immunogen of  claim 1 , further comprising a pharmaceutically acceptable excipient. 
     
     
         3 . An isolated antibody to an antigen peptide having an amino acid sequence selected from the group consisting of SEQ ID NOS:1-16, or a fragment thereof, wherein the fragment comprises at least 4 continuous amino acid residues, wherein the antibody is capable of binding to a native norovirus capsid structure. 
     
     
         4 . The antibody of  claim 3 , wherein the antibody is polyclonal. 
     
     
         5 . The antibody of  claim 3 , wherein the antibody is monoclonal. 
     
     
         6 . The antibody of  claim 5 , wherein the antibody is humanized. 
     
     
         7 . The antibody of  claim 3 , wherein the amino acid sequence is SEQ ID NO:7. 
     
     
         8 . The antibody of  claim 3 , wherein the antibody is capable of binding to GI genogroup norovirus but not capable of binding to GII genogroup norovirus. 
     
     
         9 . An antibody of  claim 3 , wherein the antibody is capable of binding to GII genogroup norovirus but not capable of binding to GI genogroup norovirus. 
     
     
         10 . The antibody of  claim 3 , wherein the antibody is capable of binding GI genogroup norovirus and GII genogroup norovirus. 
     
     
         11 . The antibody of  claim 3 , wherein the antibody is generated from one or more amino acid sequences selected from the group consisting of SEQ ID NOS:1-16. 
     
     
         12 . The antibody of  claim 6 , wherein the antibody is present in a mixture of two or more distinct antibodies to antigen peptides having amino acid sequences selected from the group consisting of SEQ ID NOS:1-16, or fragments thereof, wherein the fragments comprise at least 4 continuous amino acid residues, wherein a plurality of antibodies in the mixture are capable of binding to a native norovirus capsid structure. 
     
     
         13 . A composition comprising the antibody of any of  claims 3 - 12 , further comprising a pharmaceutically acceptable excipient. 
     
     
         14 . The composition of  claim 13 , wherein the composition is formulated for oral administration. 
     
     
         15 . The composition of  claim 13 , further comprising IgY. 
     
     
         16 . A method for making an antibody comprising immunizing a subject with one or more peptides having an amino acid sequence selected from the group consisting of SEQ ID NOS:1-16, wherein the subject expresses an antibody to the one or more peptides following the immunization. 
     
     
         17 . The method of  claim 16 , further comprising the step of collecting an expressed antibody product from the subject, wherein the subject is a non-human animal, and wherein the expressed antibody product comprises an antibody capable of binding to a native norovirus capsid structure. 
     
     
         18 . The method of  claim 17 , further comprising the step of preparing a monoclonal antibody from the expressed antibody product. 
     
     
         19 . A vaccine comprising:
 (i) one or more antigen peptides selected from the group consisting of SEQ ID NOS:1-16, or a fragment thereof, wherein the fragment comprises at least 4 continuous amino acid residues; and, optionally,   (ii) a carrier, wherein the carrier is conjugated to at least one of the antigen peptides.   
     
     
         20 . The vaccine of  claim 19 , wherein the carrier is a protein carrier. 
     
     
         21 . The vaccine of  claim 19 , wherein the carrier is a lipid carrier. 
     
     
         22 . The vaccine of  claim 19 , wherein the carrier comprises a norovirus capsid protein or a subunit or domain thereof, or a norovirus RNA polymerase protein or a subunit or domain thereof. 
     
     
         23 . The vaccine of  claim 19 , further comprising one or more pharmaceutically acceptable excipients. 
     
     
         24 . A vaccine comprising:
 a vector DNA, wherein the vector DNA comprises DNA encoding one or more antigen peptides selected from the group consisting of SEQ ID NOS:1-16, or a fragment thereof, wherein the fragment comprises at least 4 continuous amino acid residues; and, optionally,   (ii) a pharmaceutically acceptable carrier, adjuvant, or excipient.   
     
     
         25 . A method of detecting intact norovirus in a sample comprising:
 (i) providing a sample to be tested; and   (ii) subjecting the sample to a reporting assay employing one or more antibodies recognizing one or more peptide sequences selected from the group consisting of SEQ ID NOS:1-16,   wherein if the reporting assay indicates a positive result, norovirus is present in the sample.   
     
     
         26 . The method of  claim 25 , wherein the sample is selected from the group consisting of a water sample, a food sample, an environmental sample, and a specimen sample. 
     
     
         27 . The method of  claim 25 , wherein the norovirus is human. 
     
     
         28 . The method of  claim 25 , wherein the norovirus is bovine. 
     
     
         29 . A kit for the detection of intact norovirus in a sample comprising:
 (i) a sample collection tool;   (ii) reagents for conducting a reporting assay including one or more antibodies recognizing one or more peptide sequences selected from the group consisting of SEQ ID NOS:1-16; and   (iii) instructional material for executing a test for detection of norovirus and interpreting the results.

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