Claims for Patent: 5,843,913

Summary for Patent: 5,843,913

Title:	Nucleic acid respiratory syncytial virus vaccines
Abstract:	Vectors containing a nucleotide sequence coding for an F protein of respiratory syncytial virus (RSV) and a promoter for such sequence, preferably a cytomegalovirus promoter, are described. Such vectors also may contain a further nucleotide sequence located adjacent to the RSV F protein encoding sequence to enhance the immunoprotective ability of the RSV F protein when expressed in vivo. Such vectors may be used to immunize a host, including a human host, by administration thereto. Such vectors also may be used to produce antibodies for detection of RSV infection in a sample.
Inventor(s):	Li; Xiaomao (Thornhill, CA), Ewasyshyn; Mary E. (Willowdale, CA), Sambhara; Suryaprakash (Markham, CA), Klein; Michel H. (Willowdale, CA)
Assignee:	Connaught Laboratories Limited (North York, CA)
Application Number:	08/659,939
Patent Claims:	1. A method of immunizing a host against disease caused by infection with respiratory syncytial virus (RSV), which comprises administering to said host an effective amount of a plasmid vector comprising a first nucleotide sequence encoding an RSV F protein or a RSV F protein fragment that generates antibodies that specifically react with RSV F protein, a promoter sequence operatively coupled to said first nucleotide sequence for expression of said RSV F protein or fragment thereof in said host, and a second nucleotide sequence located between said first nucleotide sequence and said promoter sequence and comprising a pair of splice sites to prevent aberrant mRNA splicing and to increase expression of said RSV F protein or fragment thereof in vivo from said vector in said host. 2. The method of claim 1 wherein said first nucleotide sequence encodes a full-length RSV F protein. 3. The method of claim 1 wherein said first nucleotide sequence encodes an RSV F protein fragment from which the transmembrane region is absent. 4. The method of claim 1 wherein said first nucleotide sequence encodes a RSV F protein and contains a translational stop codon immediately upstream of the start of the transmembrane coding region to prevent translation of the transmembrane coding region. 5. The method of claim 1 wherein said promoter sequence is an immediate early cytomegalovirus promoter. 6. The method of claim 1 wherein said second nucleotide sequence is that of rabbit .beta.-globin intron II. 7. The method of claim 1 wherein said vector is pXL2 as shown in FIG. 5. 8. The method of claim 1 wherein said vector is pXL4 as shown in FIG. 7. 9. A method of using a gene encoding an RSV F protein or a RSV F protein fragment which generates antibodies that specifically react with RSV F protein to produce an immune response in a host, which comprises: isolating said gene; operatively linking said gene to a nucleotide sequence comprising a pair of splice sites to prevent aberrant mRNA splicing and to increase expression of said RSV F protein or fragment thereof in said host; operatively linking said gene to at least one promoter sequence to produce a plasmid vector wherein said nucleotide sequence is located between said promoter sequence and said gene, said promoter sequence directing expression of said RSV F protein or fragment thereof when said vector is introduced into a host to produce an immune response to said RSV F protein; and introducing said vector into the host. 10. The method of claim 9 wherein said gene encoding an RSV F protein encodes an RSV F protein fragment lacking the transmembrane region. 11. The method of claim 9 wherein said nucleotide sequence is that of rabbit .beta.-globin intron II. 12. The method of claim 9 wherein said gene is contained within a plasmid selected from the group consisting of pXL2 and pXL4. 13. The method of claim 10 wherein said at least one promoter comprises the immediate early cytomegalovirus promoter. 14. A method of producing a vaccine for protection of a host against disease caused by infection with respiratory syncytial virus (RSV), which comprises: isolating a first nucleotide sequence encoding an RSV F protein or a RSV F protein fragment that generates antibodies that specifically react with RSV F protein; operatively linking said first nucleotide sequence to at least one promoter sequence to produce a plasmid vector, the promoter sequence directing expression of said RSV F protein or fragment thereof when introduced into a host to produce an immune response to said RSV F protein; operatively linking said first nucleotide sequence to a second nucleotide sequence between said first nucleotide sequence and said promoter sequence in said vector, said second nucleotide sequence comprising a pair of splice sites to prevent aberrant mRNA splicing and to increase expression of said RSV F protein or fragment thereof in vivo from the vector in the host, and formulating said vector as a vaccine for in vivo administration. 15. The method of claim 14 wherein said vector is selected from the group consisting of pXL2 and pXL4. 16. A vaccine produced by the method of claim 14.

Details for Patent 5,843,913

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2015-06-07
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2015-06-07
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2015-06-07