# US 8,784,837 B2 · Vaccines comprising an immunostimulatory peptide and an immunostimulatory oligodeoxynucleic acid molecule

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 8,784,837 B2
- Document ID: US8784837B2
- Status: Granted
- Kind: B2
- Application number: 12/759,318
- Filed: 2010-04-13
- Published: 2010-11-25
- Granted: 2014-07-22
- Earliest claimed: 2003-03-24
- Assignees: Valneva Austria GmbH
- Applicants: Michael Buschle; André Habel; Jörg Fritz; Karin Prinz; Karen Lingnau
- Inventors: Michael Buschle; André Habel; Jörg Fritz; Karin Prinz; Karen Lingnau
- Web page: https://patentgrep.com/patent/US8784837B2

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/29: Hepatitis virus
- A61K 39/292: {Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen}
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/12: Antivirals
- A61P 31/16: for influenza or rhinoviruses
- A61P 31/18: for HIV
- A61P 31/20: for DNA viruses
- C07K 14/005: from viruses
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55516: {Proteins; Peptides}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2}
- C12N 2730/10122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2730/10134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2760/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/24222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2770/24234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The invention refers an improved vaccine against infections with pathogens, especially viral pathogens, comprising an antigen, a peptide of the formula R1—XZSZN—XZX—R2 and an immunostimulatory deoxynucleic acid containing deoxyinosine and/or deoxyuridine residues.

## Claims

### Claim 1

A vaccine comprising:
an HBV antigen;
a peptide comprising the sequence KLKL5KLK (SEQ ID NO: 6); and
a deoxyinosine-containing immunostimulatory oligodeoxynucleic acid molecule (I-ODN), wherein the I-ODN comprises oligo-d(IC)13 (SEQ ID NO: 21).

### Claim 2 (depends on 1)

The vaccine of claim 1, further comprising an Al(OH)3 adjuvant.

### Claim 3 (depends on 1)

The vaccine of claim 1, wherein the HBV antigen is Hepatitis B surface antigen (HBsAg).

### Claim 4 (depends on 1)

The vaccine of claim 1, further comprising a polycationic peptide.

### Claim 5 (depends on 1)

The vaccine of claim 1, further comprising an oligodeoxynucleotide containing a CpG-motif.

### Claim 6 (depends on 1)

The vaccine of claim 1, further comprising a polycationic peptide and an oligodeoxynucleotide containing a CpG-motif.

### Claim 7 (depends on 1)

A method of improving protective efficacy of a vaccine against an HBV infection comprising:
obtaining a peptide comprising the sequence KLKL5KLK (SEQ ID NO: 6) and an I-ODN of claim 1, wherein the I-ODN comprises oligo-d(IC)13 (SEQ ID NO: 21); and
administering the peptide and the I-ODN with a vaccine against an HBV infection to a subject;
wherein efficacy of the vaccine against an HBV infection is improved in the subject.

### Claim 8 (depends on 1)

A method of improving an antigen-specific type 1 response of a vaccine against an HBV infection and preserving or increasing a type 2 response of said vaccine comprising:
obtaining a peptide comprising the sequence KLKL5KLK (SEQ ID NO: 6) and an I-ODN of claim 1, wherein the I-ODN comprises oligo-d(IC)13 (SEQ ID NO: 21); and
administering the peptide and the I-ODN with a vaccine against an HBV infection to a subject;
wherein the antigen-specific type 1 response to the vaccine against an HBV infection is improved in the subject and the type 2 response to the vaccine is preserved or increased in the subject.

### Claim 9

A immunogenic composition comprising:
an HCV antigen,
a peptide comprising the sequence KLKL5KLK (SEQ ID NO: 6), and
a deoxyinosine-containing immunostimulatory oligodeoxynucleic acid molecule (I-ODN), wherein the I-ODN comprises oligo-d(IC)13 (SEQ ID NO: 21).

### Claim 10 (depends on 9)

The immunogenic composition of claim 9, further comprising an Al(OH)3 adjuvant.

### Claim 11 (depends on 9)

The immunogenic composition of claim 9, wherein the HCV antigen is a peptide.

### Claim 12 (depends on 9)

The immunogenic composition of claim 9, further comprising a polycationic peptide.

### Claim 13 (depends on 9)

The immunogenic composition of claim 9, further comprising an oligodeoxynucleotide containing a CpG-motif.

### Claim 14 (depends on 9)

The immunogenic composition of claim 9, further comprising a polycationic peptide and an oligodeoxynucleotide containing a CpG-motif.

### Claim 15 (depends on 9)

A method of improving efficacy of a immunogenic composition against an HCV infection comprising:
obtaining a peptide comprising the sequence KLKL5KLK (SEQ ID NO: 6) and an I-ODN of claim 9, wherein the I-ODN comprises oligo-d(IC)13 (SEQ ID NO: 21); and
administering the peptide and the I-ODN with a immunogenic composition against an HCV infection to a subject;
wherein efficacy of the immunogenic composition against HCV infection is improved in the subject.

### Claim 16 (depends on 9)

A method of improving an antigen-specific type 1 response of a immunogenic composition against an HCV infection and preserving or increasing a type 2 response of said immunogenic composition comprising:
obtaining a peptide comprising the sequence KLKL5KLK (SEQ ID NO: 6) and an I-ODN of claim 9, wherein the I-ODN comprises oligo-d(IC)13 (SEQ ID NO: 21); and
administering the peptide and the I-ODN with a immunogenic composition against an HCV infection to a subject;
wherein the antigen-specific type 1 response to the immunogenic composition against an HCV infection is improved in the subject and the type 2 response to the immunogenic composition is preserved or increased in the subject.

### Claim 17 (depends on 8, 16)

The method of claim 8 or 16, wherein the antigen-specific type 1 response is further defined as an IgG2-antibody response or IFN-gamma response.

### Claim 18 (depends on 8, 16)

The method of claim 8 or 16, where in the type 2 response is further defined as an IgG1-antibody response or interleukin-4 (IL-4) response.