# US 5,968,514 A · Methods for stimulating immune responses in a host through the administration of superantigen peptides derived from human immunodeficiency virus type 1 Nef

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- Number: US 5,968,514 A
- Document ID: US5968514A
- Status: Granted
- Kind: A
- Application number: 08/331,454
- Filed: 1994-10-31
- Granted: 1999-10-19
- Earliest claimed: 1993-10-29
- Assignees: University of Florida
- Inventors: Howard M. Johnson; Barbara A. Torres; Janet K. Yamamoto
- Web page: https://patentgrep.com/patent/US5968514A

## CPC

- C07K 14/005: from viruses
- A61P 31/12: Antivirals
- A61P 31/18: for HIV
- C07K 16/114: Lentivirus (G), e.g. human immunodeficiency virus [HIV], feline immunodeficiency virus [FIV] or simian immunodeficiency virus [SIV]
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- C12N 2740/12022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2740/15022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2740/16322: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- Y10S 930/221: Retrovirus related, or human immunodeficiency virus related, or simian immunodeficiency virus related
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

The human immunodeficiency virus (HIV) contains, in addition to the canonical genes gag, pol, and env, an open reading frame in the 3' region of the genome that overlaps with the 3' long terminal repeat (LTR). Initial studies on the protein encoded by this ORF revealed a negative effect on HIV replication in vitro and this gene product was subsequently designated the negative factor, or Nef. The nef gene product is 25-29 kDa protein that localizes primarily to the cytoplasm of HIV-infected cells. The subject of this invention pertains to the discovery of a superantigen activity associated with this peptide and peptidic fragments derived therefrom. Superantigens are powerful T-cell mitogens that bind directly to major histocompatibility complex (MHC) class II molecules and form a binary complex with the variable .beta. (V.sub..beta.) region of the T-cell antigen receptor (TCR). It was demonstrated that Nef induces the rapid proliferation of human peripheral mononuclear cells and T-lymphocyte cytokine production. Nef peptidic fragments were also identified that display major histocompatibility complex (MHC) class II binding activity. These peptides can be utilized to generate suitable immune responses in the desired host.

## Claims

### Claim 1

A method for stimulating an immune response in an animal, said method comprising administering to said animal an effective amount of an immunogenic composition comprising a retroviral superantigen peptide, wherein said superantigen peptide is a peptide selected from the group consisting of a peptide designated HIV-1 Nef(1-38) consisting of an amino acid sequence shown in SEQ ID NO. 14 and a peptide designated HIV-1 Nef(123-160) consisting of an amino acid sequence shown in SEQ ID NO. 18, wherein said immune response is selected from the group consisting of antibody production by B lymphocytes, proliferation of CD4.sup.+ lymphoctes, the production of IL-2, and the production of IFN-.gamma..

### Claim 2

An immunogenic composition wherein said immunogenic composition comprises a retroviral superantigen peptide, wherein said superantigen peptide is a peptide selected from the group consisting of a peptide designated HIV-1 Nef(1-38) consisting of an amino acid sequence shown in SEQ ID NO. 14 and a peptide designated HIV-1 Nef (123-160) consisting of an amino acid sequence shown in SEQ ID NO. 18, in a pharmacologically-acceptable vehicle.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said immune response is antibody production by B lymphocytes.

### Claim 4 (depends on 1)

The method according to claim 1, wherein said immune response is proliferation of CD4.sup.+ lymphocytes.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said immune response is production of IL-2.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said immune response is production of IFN-.gamma..