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EP0318216A1 Expired / Lapsed EP ⏱️ 0.0 years remaining

NANBV diagnostics and vaccines

Assignee: Novartis Vaccines and Diagnostics Inc
•
Filing: 1988-11-18
•
Granted: —
•
Expires: 2008-11-18
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Abstract

Abstract A family of cDNA sequences derived from hepatitis C virus (HCV) are provided. These sequences encode antigens which react immunologically with antibod­ies present in individuals with non-A non-B hepatitis (NANBH), but which generally are absent from individuals infected with hepatitis A virus (HAV) or hepatitis B virus (HBV), and also are absent from control individuals. A comparison of these cDNA sequences with the sequences in Genebank, and with the sequences of hepatitis delta virus (HDV) and HBV shows a lack of substantial homology. A comparison of the sequences of amino acids encoded in the cDNA with the sequences of Flaviviruses indicates that HCV is a Flavivirus or Flavi-like virus. The HCV cDNA sequences are useful for the design of polynucleotide probes, and for the synthesis of polypeptides which may be used in immunoassays. Both the polynucleotide probes and the polypeptides may be useful for the diagnosis of HCV-induced NANBH, and for screening blood bank specimens and donors for HCV infection. In addition, these cDNA sequences may be useful for the synthesis of immunogenic polypeptides which may be used in vaccines for the treatment, prophylactic and/or therapeutic, of HCV infection. Polypeptides encoded within the cDNA sequences may also be used to raise anti­bodies against HCV antigens, and for the purification of antibodies directed against HCV antigens. These antibodies may be useful in immunoassays for detecting HCV antigens associated with NANBH in individuals, and in blood bank donations. Moreover, these antibodies may be used for treatment of NANBH in individuals. The reagents provided in the invention also en­able the isolation of NANBH agent(s), and the propagation of these agent(s) in tissue culture systems. Moreover, they provide reagents which are useful for screening for antiviral agents for HCV, particularly in tissue culture or animal model systems.

Inventors

  • 👤 Michael Houghton
  • 👤 Qui-Lim Choo
  • 👤 George Kuo

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-01 07:14
CPC Classifications
C; C07; C07K; C07K14/00; C07K14/005; A; A61; A61K; A61K39/00; A61P; A61P1/00; A61P1/16; A61P31/00; A61P31/12; A61P31/14; A61P37/00; A61P37/02; A61P37/04; C12; C12N; C12N15/00; C12N15/09; C12N15/11; C12N15/62; C12N5/00; C12N5/10; C12N7/00; C12Q; C12Q1/00; C12Q1/68; C12Q1/70; C12Q1/701; C12Q1/706; C12Q1/707; G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/575; G01N33/576; G01N33/5767; C07K2319/00; C07K2319/01; C07K2319/02; C07K2319/40; C12N2770/00; C12N2770/00011; C12N2770/24011; C12N2770/24211; C12N2770/24222

Claims Analysis

Total Claims: 71
Claim 1
Independent Claim 4 words
A purified HCV polynucleotide.
Claim 2
Dependent Claim 4 words
A purified HCV polynucleotide.
Claim 3
Dependent Claim 4 words
A recombinant HCV polynucleotide.
Claim 4
Dependent Claim 4 words
A recombinant HCV polynucleotide.
Claim 5
Dependent Claim 15 words
A recombinant polynucleotide comprising a sequence derived from an HCV genome or from HCV cDNA.
Claim 6
Dependent Claim 15 words
A recombinant polynucleotide comprising a sequence derived from an HCV genome or from HCV cDNA.
Claim 7
Dependent Claim 8 words
A recombinant polynucleotide encoding an epitope of HCV.
Claim 8
Dependent Claim 8 words
A recombinant polynucleotide encoding an epitope of HCV.
Claim 9
Dependent Claim 15 words
A recombinant vector containing the polynucleotide of claim 2, or claim 3, or claim 4.
Claim 10
Dependent Claim 10 words
A host cell transformed with the vector of claim 5.
Claim 11
Dependent Claim 36 words
A recombinant expression system comprising an open reading frame (ORF) of DNA derived from an HCV genome or from HCV cDNA, wherein the ORF is operably linked to a control sequence compatible with a desired host.
Claim 12
Dependent Claim 36 words
A recombinant expression system comprising an open reading frame (ORF) of DNA derived from an HCV genome or from HCV cDNA, wherein the ORF is operably linked to a control sequence compatible with a desired host.
Claim 13
Dependent Claim 11 words
A cell transformed with the recombinant expression system of claim 7.
Claim 14
Dependent Claim 9 words
A polypeptide produced by the cell of claim 8.
Claim 15
Dependent Claim 2 words
Purified HCV.
Claim 16
Dependent Claim 2 words
Purified HCV.
Claim 17
Dependent Claim 10 words
A preparation of polypeptides from the HCV of claim 10.
Claim 18
Dependent Claim 4 words
A purified HCV polypeptide.
Claim 19
Dependent Claim 4 words
A purified HCV polypeptide.
Claim 20
Dependent Claim 16 words
A purified polypeptide comprising an epitope which is immunologically identifiable with an epitope contained in HCV.
Claim 21
Dependent Claim 16 words
A purified polypeptide comprising an epitope which is immunologically identifiable with an epitope contained in HCV.
Claim 22
Dependent Claim 4 words
A recombinant HCV polypeptide.
Claim 23
Dependent Claim 4 words
A recombinant HCV polypeptide.
Claim 24
Dependent Claim 16 words
A recombinant polypeptide comprised of a sequence derived from an HCV genome or from HCV cDNA.
Claim 25
Dependent Claim 16 words
A recombinant polypeptide comprised of a sequence derived from an HCV genome or from HCV cDNA.
Claim 26
Dependent Claim 8 words
A recombinant polypeptide comprised of an HCV epitope.
Claim 27
Dependent Claim 8 words
A recombinant polypeptide comprised of an HCV epitope.
Claim 28
Dependent Claim 8 words
A fusion polypeptide comprised of an HCV polypeptide.
Claim 29
Dependent Claim 8 words
A fusion polypeptide comprised of an HCV polypeptide.
Claim 30
Dependent Claim 8 words
A monoclonal antibody directed against an HCV epitope.
Claim 31
Dependent Claim 8 words
A monoclonal antibody directed against an HCV epitope.
Claim 32
Dependent Claim 9 words
A purified preparation of polyclonal antibodies directed against HCV.
Claim 33
Dependent Claim 9 words
A purified preparation of polyclonal antibodies directed against HCV.
Claim 34
Dependent Claim 35 words
A particle which is immunogenic against HCV infection comprising a non-HCV polypeptide having an amino acid sequence capable of forming a particle when said sequence is produced in a eukaryotic host, and an HCV epitope.
Claim 35
Dependent Claim 35 words
A particle which is immunogenic against HCV infection comprising a non-HCV polypeptide having an amino acid sequence capable of forming a particle when said sequence is produced in a eukaryotic host, and an HCV epitope.
Claim 36
Dependent Claim 5 words
A polynucleotide probe for HCV.
Claim 37
Dependent Claim 5 words
A polynucleotide probe for HCV.
Claim 38
Dependent Claim 33 words
A kit for analyzing samples for the presence of polynucleotides derived from HCV comprising a polynucleotide probe containing a nucleotide sequence from HCV of about 8 or more nucleotides, in a suitable container.
Claim 39
Dependent Claim 33 words
A kit for analyzing samples for the presence of polynucleotides derived from HCV comprising a polynucleotide probe containing a nucleotide sequence from HCV of about 8 or more nucleotides, in a suitable container.
Claim 40
Dependent Claim 27 words
A kit for analyzing samples for the presence of an HCV antigen comprising an antibody directed against the HCV antigen to be detected, in a suitable container.
Claim 41
Dependent Claim 27 words
A kit for analyzing samples for the presence of an HCV antigen comprising an antibody directed against the HCV antigen to be detected, in a suitable container.
Claim 42
Dependent Claim 32 words
A kit for analyzing samples for the presence of an antibodies directed against an HCV antigen comprising a polypeptide containing an HCV epitope present in the HCV antigen, in a suitable container.
Claim 43
Dependent Claim 32 words
A kit for analyzing samples for the presence of an antibodies directed against an HCV antigen comprising a polypeptide containing an HCV epitope present in the HCV antigen, in a suitable container.
Claim 44
Dependent Claim 12 words
A polypeptide comprised of an HCV epitope, attached to a solid substrate.
Claim 45
Dependent Claim 12 words
A polypeptide comprised of an HCV epitope, attached to a solid substrate.
Claim 46
Dependent Claim 11 words
An antibody to an HCV epitope, attached to a solid substrate.
Claim 47
Dependent Claim 11 words
An antibody to an HCV epitope, attached to a solid substrate.
Claim 48
Independent Claim 37 words
A method for producing a polypeptide containing an HCV epitope comprising incubating host cells transformed with an expression vector containing a sequence encoding a polypeptide containing an HCV epitope under conditions which allow expression of said polypeptide.
Claim 49
Independent Claim 37 words
A method for producing a polypeptide containing an HCV epitope comprising incubating host cells transformed with an expression vector containing a sequence encoding a polypeptide containing an HCV epitope under conditions which allow expression of said polypeptide.
Claim 50
Dependent Claim 13 words
A polypeptide containing an HCV epitope produced by the method of claim 27.
Claim 51
Independent Claim 56 words
A method for detecting HCV nucleic acids in a sample comprising: (a) reacting nucleic acids of the sample with a probe for an HCV polynucleotide under conditions which allow the formation of a polynucleotide duplex between the probe and the HCV nucleic acid from the sample; and (b) detecting a polynucleotide duplex which contains the probe.
Claim 52
Independent Claim 56 words
A method for detecting HCV nucleic acids in a sample comprising: (a) reacting nucleic acids of the sample with a probe for an HCV polynucleotide under conditions which allow the formation of a polynucleotide duplex between the probe and the HCV nucleic acid from the sample; and (b) detecting a polynucleotide duplex which contains the probe.
Claim 53
Dependent Claim 50 words
An immunoassay for detecting an HCV antigen comprising: (a) incubating a sample suspected of containing an HCV antigen with a probe antibody directed against the HCV antigen to be detected under conditions which allow the formation of an antigen-antibody complex; and (b) detecting an antigen-antibody complex containing the probe antibody.
Claim 54
Dependent Claim 50 words
An immunoassay for detecting an HCV antigen comprising: (a) incubating a sample suspected of containing an HCV antigen with a probe antibody directed against the HCV antigen to be detected under conditions which allow the formation of an antigen-antibody complex; and (b) detecting an antigen-antibody complex containing the probe antibody.
Claim 55
Dependent Claim 51 words
An immunoassay for detecting antibodies directed against an HCV antigen comprising: (a) incubating a sample suspected of containing anti-HCV antibodies with a probe polypeptide which contains an epitope of the HCV, under conditions which allow the formation of an antibody-antigen complex; and (b) detecting the antibody-antigen complex containing the probe antigen.
Claim 56
Dependent Claim 51 words
An immunoassay for detecting antibodies directed against an HCV antigen comprising: (a) incubating a sample suspected of containing anti-HCV antibodies with a probe polypeptide which contains an epitope of the HCV, under conditions which allow the formation of an antibody-antigen complex; and (b) detecting the antibody-antigen complex containing the probe antigen.
Claim 57
Dependent Claim 31 words
A vaccine for treatment of HCV infection comprising an immunogenic polypeptide containing an HCV epitope wherein the immunogenic polypeptide is present in a pharmacologically effective dose in a pharmaceutically acceptable excipient.
Claim 58
Dependent Claim 31 words
A vaccine for treatment of HCV infection comprising an immunogenic polypeptide containing an HCV epitope wherein the immunogenic polypeptide is present in a pharmacologically effective dose in a pharmaceutically acceptable excipient.
Claim 59
Dependent Claim 20 words
A vaccine for treatment of HCV infection comprising inactivated HCV in a pharmacologically effective dose in a pharmaceutically acceptable excipient.
Claim 60
Dependent Claim 20 words
A vaccine for treatment of HCV infection comprising inactivated HCV in a pharmacologically effective dose in a pharmaceutically acceptable excipient.
Claim 61
Dependent Claim 20 words
A vaccine for treatment of HCV infection comprising attenuated HCV in a pharmacologically effective dose in a pharmaceutically acceptable excipient.
Claim 62
Dependent Claim 20 words
A vaccine for treatment of HCV infection comprising attenuated HCV in a pharmacologically effective dose in a pharmaceutically acceptable excipient.
Claim 63
Dependent Claim 8 words
A tissue culture grown cell infected with HCV.
Claim 64
Dependent Claim 8 words
A tissue culture grown cell infected with HCV.
Claim 65
Dependent Claim 51 words
The HCV infected cell of claim 35, wherein the cell is of a human macrophage cell line, or is of a hepatocyte cell line, or is of a mosquito cell line, or is of a tick cell line, or is of a mouse macrophage cell line, or is an embryonic cell.
Claim 66
Dependent Claim 23 words
The HCV infected cell of claim 35, wherein the cell is of a cell line derived from liver of an HCV infected individual.
Claim 67
Independent Claim 29 words
A method for producing antibodies to HCV comprising administering to an individual an isolated immunogenic polypeptide containing an HCV epitope in an amount sufficient to produce an immune response.
Claim 68
Independent Claim 29 words
A method for producing antibodies to HCV comprising administering to an individual an isolated immunogenic polypeptide containing an HCV epitope in an amount sufficient to produce an immune response.
Claim 69
Dependent Claim 40 words
A method for producing antibodies to HCV comprising administering to an individual the polypeptide preparation of claim 11, wherein the preparation contains at least 1 immunogenic polypeptide, and the administering is of an amount sufficient to produce an immune response.
Claim 70
Independent Claim 242 words
A method for isolating cDNA derived from the genome of an unidentified infectious agent, comprising: (a) providing host cells transformed with expression vectors containing a cDNA library prepared from nucleic acids isolated from tissue infected with the agent and growing said host cells under conditions which allow expression of polypeptide(s) encoded in the cDNA; (b) interacting the expression products of the cDNA with an antibody containing body component of an individual infected with said infectious agent under conditions which allow an immunoreaction, and detecting antibody-antigen complexes formed as a result of the interacting; (c) growing host cells which express polypeptides that form antibody-antigen complexes in step (b) under conditions which allow their growth as individual clones and isolating said clones; (d) growing cells from the clones of (c) under conditions which allow expression of polypeptide(s) encoded within the cDNA, and interacting the expression products with antibody containing body components of individuals other than the individual in step (a) who are infected with the infectious agent and with control individuals uninfected with the agent, and detecting antibody-antigen complexes formed as a result of the interacting; (e) growing host cells which express polypeptides that form antibody-antigen complexes with antibody containing body components of infected individuals and individuals suspected of being infected, and not with said components of control individuals, under conditions which allow their growth as individual clones and isolating said clones; and (f) isolating the cDNA from the host cell clones of (e).
Claim 71
Independent Claim 242 words
A method for isolating cDNA derived from the genome of an unidentified infectious agent, comprising: (a) providing host cells transformed with expression vectors containing a cDNA library prepared from nucleic acids isolated from tissue infected with the agent and growing said host cells under conditions which allow expression of polypeptide(s) encoded in the cDNA; (b) interacting the expression products of the cDNA with an antibody containing body component of an individual infected with said infectious agent under conditions which allow an immunoreaction, and detecting antibody-antigen complexes formed as a result of the interacting; (c) growing host cells which express polypeptides that form antibody-antigen complexes in step (b) under conditions which allow their growth as individual clones and isolating said clones; (d) growing cells from the clones of (c) under conditions which allow expression of polypeptide(s) encoded within the cDNA, and interacting the expression products with antibody containing body components of individuals other than the individual in step (a) who are infected with the infectious agent and with control individuals uninfected with the agent, and detecting antibody-antigen complexes formed as a result of the interacting; (e) growing host cells which express polypeptides that form antibody-antigen complexes with antibody containing body components of infected individuals and individuals suspected of being infected, and not with said components of control individuals, under conditions which allow their growth as individual clones and isolating said clones; and (f) isolating the cDNA from the host cell clones of (e).

References Cited (Backward Citations)

WO1982000205A1 Cited
WO1982002774A1 Cited
EP0194207A2 Cited
EP0263761A2 Cited
WO1988003410A1 Cited
EP0279460A1 Cited

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