# US 8,772,256 B2 · Codon modified immunogenic compositions and methods of use

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- Number: US 8,772,256 B2
- Document ID: US8772256B2
- Status: Granted
- Kind: B2
- Application number: 12/517,194
- Filed: 2007-11-30
- Published: 2010-09-30
- Granted: 2014-07-08
- Earliest claimed: 2006-11-30
- Assignees: The United States of America, as represented by the Secretary, Department of Health and Human Services
- Applicants: Barney S. Graham; Teresa R. Johnson
- Inventors: Barney S. Graham; Teresa R. Johnson
- Web page: https://patentgrep.com/patent/US8772256B2

## CPC

- C07K 14/005: from viruses
- A61K 39/12: Viral antigens
- A61K 39/155: Paramyxoviridae, e.g. parainfluenza virus
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2710/24143: viral genome or elements thereof as genetic vector
- C12N 2760/18522: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2760/18534: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/36143: viral genome or elements thereof as genetic vector
- 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)
- 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)

## Abstract

The present invention features immunogenic compositions comprising codon modified genes that encode viral proteins and/or glycoproteins or fragments. The immunogenic compositions of the invention are useful in various methods of treatment, such as preventing or treating viral infection. Also provided in the present invention are kits and instructions for use.

## Claims

### Claim 1

An immunogenic composition for eliciting a CD8+ T cell and antibody response comprising a codon-modified gene encoding a Respiratory Syncytial Virus (RSV) F protein, wherein the codon-modified F gene comprises SEQ ID NO: 14, 17, or 18.

### Claim 2 (depends on 1)

The immunogenic composition according to claim 1, wherein the codon-modified gene induces an immune response.

### Claim 3 (depends on 2)

The immunogenic composition of claim 2, wherein the immune response is a T cell response.

### Claim 4 (depends on 1)

The immunogenic composition of claim 1, wherein the codon-modified gene comprises one or more mutations.

### Claim 5 (depends on 1)

The immunogenic composition of claim 1, wherein the codon-modified F gene comprises SEQ ID NO: 17 or 18.

### Claim 6 (depends on 1)

A kit for use in eliciting an immune response capable of preventing an RSV infection in a subject, the kit comprising:
the immunogenic composition of claim 1; and
a pharmaceutically acceptable carrier.

### Claim 7

A nucleic acid molecule comprising a codon-modified gene encoding a Respiratory Syncytial Virus (RSV) F protein, wherein said gene comprises SEQ ID NO:14, 17, or 18.

### Claim 8

A vector comprising a nucleic acid molecule selected from the group consisting of SEQ ID NO: 14, 17, and 18.

### Claim 9 (depends on 8)

The vector of claim 8, wherein the nucleic acid molecule is a codon modified sequence that increases expression, optimizes an immunostimulatory signal, or removes a cryptic splice site.

### Claim 10 (depends on 8)

The vector of claim 8, wherein the vector is a DNA plasmid.

### Claim 11 (depends on 8)

The vector of claim 8, wherein the vector is a replication competent or replication defective vector.

### Claim 12 (depends on 11)

The vector of claim 11, wherein the replication competent vector is selected from the group consisting of: parainfluenza virus, Paramyxovirus, Newcastle disease virus, VSV, BCG, vaccinia, reovirus, rhinovirus, poliovirus, and adenovirus.

### Claim 13 (depends on 11)

The vector of claim 11, wherein the replication defective vector is selected from the group consisting of: poxviruses, alpha viruses, Venezuelan equine encephalitis viruses (EEV), Sinbis viruses, DNA viruses, adeno associated viruses (AAV), herpes simplex viruses (HSV), adenoviruses, and HPV virus-like particles.

### Claim 14 (depends on 8)

A host cell comprising the vector of claim 8.

### Claim 15 (depends on 1)

A method of eliciting a CD8+ T cell and antibody response capable of preventing an RSV infection in a subject comprising
administering to the subject the immunogenic composition of claim 1 and a pharmaceutically acceptable carrier.

### Claim 16 (depends on 15)

The method of claim 15, wherein the immunogenic composition is administered in a prime boost regimen.

### Claim 17 (depends on 16)

The method of claim 16, wherein the prime boost regimen increases T cell cytolytic function.