Claims for Patent: 7,612,168

Summary for Patent: 7,612,168

Title:	Modified HIV peptides, antigens, compositions, immunoassay kit and a method of detecting antibodies induced by HIV
Abstract:	The present invention comprises novel and modified peptides capable of inducing a HIV-1 specific immune response without antagonizing the cytotoxic T-cell activity in order to achieve an effective prophylactic and therapeutic vaccine against HIV. The peptides are based on conserved regions of HIV gag p17 and p24 proteins. Antigens in free- or carrier-bound form comprising at least one of the said peptides, vaccine compositions containing at least one of the antigens, immunoassay kits and a method of detecting antibodies induced by HIV or HIV specific peptides using such antigens, are described.
Inventor(s):	Sorensen; Birger (Skien, NO)
Assignee:	Bionor Immuno As (Gulset Skien, NO)
Application Number:	11/211,576
Patent Claims:	1. An isolated peptide from HIV-1 Gag p24 protein, which comprises at least one amino acid sequence which contains modifications compared with the native sequence and is selected from the group consisting of: Xaa.sub.1 Xaa.sub.2 Xaa.sub.3 Xaa.sub.4 Xaa.sub.5 Xaa.sub.6 Xaa.sub.7 Gly Xaa.sub.9 Leu Val Xaa.sub.12 Xaa.sub.13 Xaa.sub.14 Tyr Xaa.sub.16 Xaa.sub.17 Xaa.sub.18 Xaa.sub.19 Xaa.sub.20 Xaa.sub.21 Xaa.sub.22 Xaa.sub.23 Ala Xaa.sub.25 Xaa.sub.26 Xaa.sub.27 Xaa.sub.28 (SEQ ID NO: 4), wherein Xaa.sub.1 is Pro, Tyr or Phe, Xaa.sub.2 is Ile, Val or Leu, Xaa.sub.3 is Ile, Leu, Val, Ala or Met, Xaa.sub.4 is Gln, Ser, Thr or Val, Xaa.sub.5 is Asn, Asp or Thr, Xaa.sub.6 is Ile, Ala, Leu or Met, Xaa.sub.7 is Gln, Glu, Lys or Gly, Xaa.sub.9 is Gln or Ile, Xaa.sub.12 is none, Xaa.sub.13 is none, Xaa.sub.14 is none, Xaa.sub.16 is Ala, Ser, Asn, Val or Pro, Xaa.sub.17 is Ile, Leu, Met or Val, Xaa.sub.18 is Ser or Thr, Xaa.sub.19 is Pro or Ala, Xaa.sub.20 is Arg or Lys, Xaa.sub.21 is Thr or Ser, Xaa.sub.22 is Leu or Ser, Xaa.sub.23 is Asn, Phe or Val, Xaa.sub.25 is Trp, Tyr, Gly or none, Xaa.sub.26 is Val, Leu, Gly or none, Xaa.sub.27 is Lys, Arg, Gly or none, Xaa.sub.28 is Val, Ala, Cys, Gly or none; Xaa.sub.1 Ala Xaa.sub.3 Xaa.sub.4 Xaa.sub.5 Ala Xaa.sub.7 Xaa.sub.8 Xaa.sub.9 Leu Leu Xaa.sub.12 Xaa.sub.13 Xaa.sub.14 Xaa.sub.15 Xaa.sub.16 Xaa.sub.17 Xaa.sub.18 Xaa.sub.19 His Gln Xaa.sub.22 Ala Xaa.sub.24 Xaa.sub.25 (SEQ ID NO: 9), wherein Xaa.sub.1 is Tyr, Trp, Phe or Gly, Xaa.sub.3 is Thr, Ala, Val, Ile or Leu, Xaa.sub.4 is Pro or Ser, Xaa.sub.5 is Gln, His, Gly, Thr, Ser or Tyr, Xaa.sub.7 is Leu, Ile or Val, Xaa.sub.8 is Asn or Tyr, Xaa.sub.9 is Thr, Met, Leu or Ala, Xaa.sub.12 is Ser, Thr or Asn, Xaa.sub.13 is Thr, Ile, Val or Ala, Xaa.sub.14 is Val or Ile, Xaa.sub.15 is none, Xaa.sub.16 is none, Xaa.sub.17 is none, Xaa.sub.18 is Gly or none, Xaa.sub.19 is Gly or none, Xaa.sub.22 is Ala or Gly, Xaa.sub.24 is Met, Leu, Cys or none, Xaa.sub.25 is Gln, Glu, His, Gly or none; Xaa.sub.1 Xaa.sub.2 Ala Leu Ala Gly Xaa.sub.7 Xaa.sub.8 Xaa.sub.9 Leu Xaa.sub.11 Xaa.sub.12 Xaa.sub.13 Xaa.sub.14 Xaa.sub.15 Xaa.sub.16 Xaa.sub.17 Xaa.sub.18 Xaa.sub.19 Xaa.sub.20 Xaa.sub.21 (SEQ ID NO: 15), wherein Xaa.sub.1 is Trp or Tyr, Xaa.sub.2 is Ser or Ala, Xaa.sub.7 is Thr, Ala or Ser, Xaa.sub.8 is Ser or Thr, Xaa.sub.9 is Ser or Thr, Xaa.sub.11 is Leu, Pro, Val or Gln, Xaa.sub.12 is Gin, Ala or His, Xaa.sub.13 is Glu or Gly, Xaa.sub.14 is Gin or His, Xaa.sub.15 is Ile, Leu, Val or Met, Xaa.sub.16 is Gly, Ala, Gln, Thr, Asn, Arg, His or Ile, Xaa.sub.17 is Trp or Tyr, Xaa.sub.18 is Thr, Met, Leu or Ile, Xaa.sub.19 is Thr or Ser, Xaa.sub.20 is Cys, Gly or none, Xaa.sub.21 is Gly or none wherein the terminal ends of the sequences may be free carboxyl- or amino groups, amides, acyls, acetyls or salts thereof, two or more of the Cys residues may form part of an interchain disulphide binding, a --S--(CH2).sub.p--S-- or a --(CH2).sub.p---bridge wherein p=1-8 optionally intervened by one or more hetero atoms such as O, N and S and/or the said peptide sequences are immobilized to a solid support. 2. The isolated peptide according to claim 1, wherein the amino acid sequence of SEQ ID NO 4 is selected from the group consisting of SEQ ID NO: 5, SEQ ID NO: 6 and SEQ ID NO: 8. 3. The isolated peptide according to claim 1, wherein the amino acid sequence of SEQ ID NO: 9 is SEQ ID NO: 11. 4. The isolated peptide according to claim 1, wherein the amino acid sequence of SEQ ID NO: 15 is SEQ ID NO: 14. 5. An antigen comprising at least one peptide according to claim 1. 6. The antigen according to claim 5, which comprises at least one peptide selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 9 and SEQ ID NO: 15. 7. An immunogenic composition, comprising the antigen according to claim 5 with a pharmaceutically acceptable diluent and optionally an adjuvant, carrier and/or vehicle and optionally additional immunostimulatory compound(s). 8. The immunogenic composition according to claim 7, which comprises at least one peptide selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 9 and SEQ ID NO: 15. 9. The immunogenic composition according to claim 7, which comprises the peptides of SEQ ID NO: 11. 10. The immunogenic composition according to claim 7, wherein the peptides are dissolved in a sterile water solution and the optional immunostimulatory compound is a granulocyte macrophage colony stimulating factor. 11. The immunogenic composition according to claim 7, wherein the composition comprises an adjuvant selected from the group consisting of Monophosphoryl Lipid A (MPL), Freund's complete adjuvant or Freund's incomplete adjuvant and aluminum hydroxide. 12. An immunogenic composition, comprising the antigen according to claim 5, wherein the antigen is formulated as a lipopeptide and/or a liposome formulation. 13. A method of detecting antibodies, induced by a HIV or HIV-specific peptide(s) or protein(s), in a sample of body fluid, comprising subjecting the sample to an immunoassay, wherein the antigen(s) is/are selected from the peptides of claim 1. 14. An immunoassay kit for the detection of antibodies, induced by a HIV or HIV-specific peptides or proteins, in a sample of body fluid, comprising a diagnostic antigen which is the peptide of claim 1. 15. The immunogenic composition according to claim 8, which comprises at least one peptide of SEQ ID NO: 11.

Details for Patent 7,612,168

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2020-09-04