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Last Updated: March 29, 2024

Claims for Patent: 6,787,351


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Summary for Patent: 6,787,351
Title: Adenovirus carrying gag gene HIV vaccine
Abstract:An adenoviral vector is described which carries a codon-optimized gag gene, along with a heterologous promoter and transcription terminator. This viral vaccine can effectively prevent HIV infection when administered to humans either alone or as part of a prime and boost regime also with a vaccine plasmid.
Inventor(s): Chen; Ling (Blue Bell, PA), Shiver; John W. (Doylestown, PA), Bett; Andrew J. (Lansdale, PA), Casimiro; Danilo R. (Harleysville, PA), Caulfield; Michael J. (Fort Washington, PA), Chastain; Michael A. (Glenside, PA), Emini; Emilio A. (Strafford, PA)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:09/818,443
Patent Claims:1. A vaccine composition comprising a replication defective adenoviral vector comprising at least one gene encoding a HIV gag protein which is codon optimized for expression in a human, and the gene is operably linked to a heterologous promoter and transcription terminator.

2. An adenoviral vaccine vector comprising: a) a replication defective adenoviral vector, wherein the adenoviral vector does not have a functional E1 gene, and further comprising: b) a gene expression cassette comprising: i) a nucleic acid encoding a gag protein which is codon optimized for expression in a human host; ii) a heterologous promoter operatively linked to the nucleic acid encoding the gag protein; and iii) a transcription terminator.

3. A vector according to claim 2, wherein the E1 gene has been deleted from the adenoviral vector.

4. A vector according to claim 3, wherein the gene expression cassette has replaced the deleted E1 gene.

5. A vector according to claim 3, wherein the adenovirus vector does not have a functional E3 gene.

6. A vector according to claim 5 wherein the E3 gene has been deleted from the replication defective adenoviral vector.

7. A vector according to claim 6 comprising adenoviral 5 sequences deleted of E1 region base pairs (bp) 342-3523 and deleted of E3 region bp 28,133-30,818.

8. A vector according to claim 6 comprising adenoviral 2 sequences deleted of E1 region bp 559-3503 and E3 region bp 28,812-29,773.

9. A vector according to claim 8 comprising the sequence given in FIG. 6.

10. A vector according to claim 8 wherein the sequence is tPA-gag.

11. A vector according to claim 2 further comprising a physiologically acceptable carrier.

12. An adenoviral vaccine composition for producing an immune response against human immunodeficiency virus (HIV) in a human comprising: a) adenovirus serotype 5 sequences bp 1 to bp 341 and bp 3534 to 5798; and b) a gene expression cassette, located 3' to adenovirus sequence bp 341, comprising: i) a nucleic acid encoding gag which is codon-optimized and optionally has the tPA leader sequence at its 5' end; ii) a human CMV promoter plus intron A operatively linked to the nucleic acid encoding gag; and iii) a bovine growth hormone transcription terminator.

13. A plasmid vector comprising: a) an adenoviral portion comprising an adenoviral vector according to claim 2; and b) a plasmid portion.

14. A cell comprising an adenoviral vector of claim 2.

15. A method of producing the vector of claim 2 comprising introducing the adenoviral vector of claim 2 into a host cell which expresses adenoviral E1 protein, and harvesting the resultant adenoviral vectors.

16. A method according to claim 15 wherein the cell is a 293 cell or PER.C6 cell.

17. A method of generating a cellular immune response against an HIV protein in an individual comprising administering to the individual at least one adenovirus vaccine vector and a vaccine plasmid, wherein said adenovirus vaccine vector comprises: a) a replication defective adenoviral vector, wherein the adenoviral vector does not have a functional E1 gene, and b) a gene expression cassette comprising: i) a nucleic acid encoding gag protein optimized for expression in a human host; ii) a heterologous promoter operatively linked to the nucleic acid encoding the gag protein; and iii) a transcription terminator; and wherein said vaccine plasmid comprises: a) a gene expression cassette comprising: a nucleic acid encoding a gag protein, wherein the nucleic acid is codon optimized for expression in a human host; b) a promoter; and c) a transcription terminator

wherein the vaccine plasmid does not contain any adenoviral genes.

18. A method according to claim 17 comprising administering a vaccine plasmid to the individual, and after a predetermined minimum amount of time has passed, administering an adenovirus vaccine vector to the individual.

19. A method according to claim 17 comprising administering an adenovirus vaccine vector to the individual, and after a predetermined minimum amount of time has passed, administering a vaccine plasmid to the individual.

20. A method according to claim 17 comprising administering an adenovirus vaccine vector to the individual, and after a predetermined minimum amount of time has passed, re-administering an adenovirus vector to the individual.

Details for Patent 6,787,351

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 ⤷  Try a Trial 2019-07-06
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b For Injection 103132 ⤷  Try a Trial 2019-07-06
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b Injection 103132 ⤷  Try a Trial 2019-07-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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