Causative agent of the mystery Swine disease, vaccine compositions and diagnostic kits

• US 20030118608A1
• Filed: 08/21/2002
• Published: 06/26/2003
• Est. Priority Date: 06/06/1991
• Status: Active Grant

• Current Assignee: Stichting Dienst Landbouwkundig Onderzoek
• Original Assignee: Stichting Dienst Landbouwkundig Onderzoek
• Inventors: Terpstra, Catharinus, Wensvoort, Gert, Meulenberg, Johanna Jacoba Maria, Moormann, Robertus Jacobus Maria, Pol, Joannes Maria Anthonis
• Granted Patent: US 6,806,086 B2
• Time in Patent Office: Days
• US Class Current: 424/204.1
• CPC Class Codes: A61K 2039/525 Virus
• CPC Class Codes: A61K 2039/5252 inactivated (killed)
• CPC Class Codes: A61K 2039/5254 avirulent or attenuated
• CPC Class Codes: A61K 2039/53 DNA (RNA) vaccination
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: C07K 14/005 from viruses
• CPC Class Codes: C07K 16/10 from RNA viruses
• CPC Class Codes: C12N 2770/10021 Viruses as such, e.g. new isolates, mutants or their genomic sequences
• CPC Class Codes: C12N 2770/10022 New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
• CPC Class Codes: C12N 2770/10034 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 7/00 Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 1/6888 for detection or identification of organisms
• CPC Class Codes: Y10S 424/815 Viral vaccine for porcine species, e.g. swine
• CPC Class Codes: Y10S 435/975 Kit

Abstract

Composition of matter comprising the causative agent of Mystery Swine Disease, Lelystad Agent, in a live, attenuated, dead, or recombinant form, or a part or component of it. Vaccine compositions and diagnostic kits based thereon. Recombinant nucleic acid comprising a Lelystad Agent-specific nucleotide sequence. Peptides comprising a Lelystad Agent-specific amino acid sequence. Lelystad Agent-specific antibodies.

Claims

1. Composition of matter comprising isolated Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

2. Composition of matter comprising killed isolated Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

3. Composition of matter comprising attenuated isolated Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

4. Composition of matter comprising a recombinant vector derived from Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

5. Composition of matter comprising an isolated part or component of Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

6. Composition of matter comprising isolated or synthetic protein, (poly)peptide, or nucleic acid derived from Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

7. Composition of matter comprising recombinant nucleic acid which comprises a nucleotide sequence derived from the genome of Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

8. Composition of matter comprising recombinant nucleic acid which comprises a Lelystad Agent-specific nucleotide sequence shown in FIG. 1.

9. Composition of matter comprising recombinant nucleic acid which comprises a Lelystad Agent-specific nucleotide sequence selected from anyone of the Open Reading Frames shown in FIG. 1.

10. Composition of matter comprising a (poly)peptide having an amino acid sequence derived from a protein of Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, the (poly)peptide being produced by a cell capable of producing it due to genetic engineering with appropriate recombinant DNA.

11. Composition of matter comprising a (poly)peptide comprising a Lelystad Agent-specific amino acid sequence shown in FIG. 1.

12. Composition of matter comprising an isolated or synthetic antibody which specifically recognizes a part or component of Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

13. Composition of matter comprising a recombinant vector which contains nucleic acid comprising a nucleotide sequence coding for a protein or antigenic peptide derived from Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

14. Vaccine composition for vaccinating animals, in particular mammals, more in particular pigs or swine, to protect them against Mystery Swine Disease, comprising Lelystad Agent which is the causative agent of Mystery swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, and a suitable carrier or adjuvant.

15. Vaccine composition for vaccinating animals, in particular mammals, more in particular pigs or swine, to protect them against Mystery Swine Disease, comprising killed Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, and a suitable carrier or adjuvant.

16. Vaccine composition for vaccinating animals, in particular mammals, more in particular pigs or swine, to protect them against Mystery Swine Disease, comprising attenuated Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, and a suitable carrier or adjuvant.

17. Vaccine composition for vaccinating animals, in particular mammals, more in particular pigs or swine, to protect them against Mystery Swine Disease, comprising a recombinant vector which contains nucleic acid comprising a nucleotide sequence coding for a protein or antigenic peptide derived from Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.9 1) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, and a suitable carrier or adjuvant.

18. Vaccine composition for vaccinating animals, in particular mammals, more in particular pigs or swine, to protect them against Mystery Swine Disease, comprising an antigenic part or component of Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, and a suitable carrier or adjuvant.

19. Vaccine composition for vaccinating animals, in particular mammals, more in particular pigs or swine, to protect them against Mystery Swine Disease, comprising a protein or antigenic polypeptide derived from, or a peptide mimicking an antigenic component of, Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, and a suitable carrier or adjuvant.

20. Vaccine composition for vaccinating animals, in particular mammals, more in particular pigs or swine, to protect them against a disease caused by a pathogen, comprising a recombinant vector derived from Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, the nucleic acid of the recombinant vector comprising a nucleotide sequence coding for a protein or antigenic peptide derived from the pathogen, and a suitable carrier or adjuvant.

21. Diagnostic kit for detecting nucleic acid from Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, in a sample, in particular a biological samples such as blood or blood serum, sputum, saliva, or tissue, derived from an animal, in particular a mammal, more in particular a pig or swine, comprising a nucleic acid probe or primer which comprises a nucleotide sequence derived from the genome of Lelystad Agent, and suitable detection means of a nucleic acid detection assay.

22. Diagnostic kit for detecting antigen from Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, in a sample, in particular a biological sample such as blood or blood serum, sputum, saliva, or tissue, derived from an animal, in particular a mammal, more in particular a pig or swine, comprising an antibody which specifically recognizes a part or component of Lelystad Agent, and suitable detection means of an antigen detection assay.

23. Diagnostic kit for detecting an antibody which specifically recognizes Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, in a sample, in particular a biological sample such as blood or blood serum, sputum, saliva, or tissue, derived from an animal, in particular a mammal, more in particular a pig or swine, comprising an antigenic part or component of Lelystad Agent, and suitable detection means of an antibody detection assay.

24. Diagnostic kit for detecting an antibody which specifically recognizes Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, in a sample, in particular a biological sample such as blood or blood serum, sputum, saliva, or tissue, derived from an animal, in particular a mammal, more in particular a pig or swine, comprising a protein or antigenic polypeptide derived from Lelystad Agent, or a peptide mimicking an antigenic component of Lelystad Agent, and suitable detection means of an antibody detection assay.

25. Diagnostic kit for detecting an antibody which specifically recognizes Lelystad Agent which is the causative agent of Mystery Swine Disease, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, in a sample, in particular a biological sample such as blond or blond serum, sputum, saliva, or tissue, derived from an animal, in particular a mammal, more in particular a pig or swine, comprising killed, live or attenuated Lelystad Agent, and suitable detection means of an antibody detection assay.

26. A process for diagnosing whether an animal, in particular a mammal, more in particular a pig or swine, is contaminated with the causative agent of Mystery Swine Disease, comprising preparing a sample, in particular a biological sample such as blond or blond serum, sputum, saliva, or tissue, derived from the animal, and examining whether it contains Lelystad Agent nucleic acid, Lelystad Agent antigen, or antibody specifically recognizing Lelystad Agent, said Lelystad Agent being the causative agent of Mystery Swine Disease and essentially corresponding to the isolate Lelystad Agent (CDI-NL-2.91) deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

27. A diagnostic kit for detecting nucleic acid from Lelystad Agent, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, in a biological sample, derived from an animal, said diagnostic kit comprising:

a nucleic acid probe or primer which comprises a nucleotide sequence essentially corresponding to the genome of Lelystad Agent, and means for detecting nucleic acid.

28. The diagnostic kit of claim 27 wherein the means for detecting a nucleic acid comprises a hybridization of the nucleic acid probe or primer.

29. The diagnostic kit of claim 28 wherein the means for detecting a nucleic acid comprises polymerase chain reaction (“

PCR”

).

30. A diagnostic kit for detecting an antibody which specifically recognizes Lelystad Agent in a biological sample derived from an animal, said kit comprising

an antigen selected from the group consisting of virus, protein, polypeptide, and peptide, said antigen immunoreactive with serum antibodies of a sow, said serum antibodies obtained by:

a) intranasally inoculating a specific pathogen free sow with two milliliters of a virus essentially corresponding to the virus identified as deposit number I- 1102, deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France (at passage level 3, titer 10^4.8TCID₅₀ / milliliter); and

further comprising

b) collecting serum antibodies from the thus inoculated sow after 25 to 33 days, and

means for detecting said antibody.

31. A diagnostic kit for detecting an antibody which specifically recognizes Lelystad Agent, said Lelystad Agent essentially corresponding to the isolated Lelystad Agent deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102, in a sample derived from an animal said diagnostic kit comprising:

a protein or antigenic polypeptide derived from Lelystad Agent, or a peptide mimicking an antigenic component of Lelystad Agent, and

means for detecting an antibody reacting with said protein or antigenic polypeptide derived from Lelystad Agent, or a peptide mimicking an antigenic component of Lelystad Agent.

32. A diagnostic kit for detecting an antibody which specifically recognizes a causative agent of Mystery Swine Disease, said causative agent being at least partially antigenically cross-reactive with Lelystad Agent essentially corresponding to the isolated Lelystad Agent deposited Jun. 5, 1991 with the Institut Pasteur;

Paris, France, deposit number I-1102, in a sample derived from an animal, said diagnostic kit comprising

said causative agent, and

means for detecting said antibody.

33. The diagnostic kit of claim 32 wherein the causative agent is live.

34. A process for detecting a causative agent of Mystery Swine Disease in an animal, comprising preparing a sample derived from the animal, and examining whether the sample contains Lelystad Agent nucleic acid, Lelystad Agent antigen, or antibody specifically recognizing Lelystad Agent, said Lelystad Agent essentially corresponding to the isolate Lelystad Agent deposited Jun. 5, 1991 with the Institut Pasteur, Paris, France, deposit number I-1102.

35. The process according to claim 34 wherein said sample is serum taken from the animal.