# US 7,407,661 B2 · Methods and reagents that generate a CD8 T cell immune response

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- Number: US 7,407,661 B2
- Document ID: US7407661B2
- Status: Granted
- Kind: B2
- Application number: 10/833,744
- Filed: 2004-04-28
- Published: 2004-10-07
- Granted: 2008-08-05
- Earliest claimed: 1997-06-09
- Assignees: Oxxon Therapeutics Ltd.
- Inventors: Andrew McMichael; Adrian V. S. Hill; Sarah C. Gilbert; Jörg Schneider; Magdalena Plebanski; Tomas Hanke; Geoffrey L. Smith; Tom Blanchard
- Web page: https://patentgrep.com/patent/US7407661B2

## CPC

- C12N 15/86: Viral vectors
- A61K 38/1709: {from mammals}
- A61K 39/0011: {Cancer antigens}
- A61K 39/015: Hemosporidia antigens, e.g. Plasmodium antigens
- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/21: Retroviridae, e.g. equine infectious anemia virus
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/12: Antivirals
- A61P 31/16: for influenza or rhinoviruses
- A61P 31/18: for HIV
- A61P 31/20: for DNA viruses
- A61P 33/06: Antimalarials
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- C07K 14/005: from viruses
- C07K 14/445: Plasmodium
- A61K 2039/51: {comprising whole cells, viruses or DNA/RNA}
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/5258: {Virus-like particles}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55522: {Cytokines; Lymphokines; Interferons}
- A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2}
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2710/24043: viral genome or elements thereof as genetic vector
- C12N 2710/24143: viral genome or elements thereof as genetic vector
- C12N 2740/15034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2740/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2740/16234: 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
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

New methods and reagents for vaccination are described which generate a CD8 T cell immune response against malarial and other antigens such as viral and tumour antigens. Novel vaccination regimes are described which employ a priming composition and a boosting composition, the boosting composition comprising a non-replicating or replication-impaired pox virus vector carrying at least one CD8 T cell epitope which is also present in the priming composition.

## Claims

### Claim 1

A method for generating a CD8+ T cell immune response in a human against hepatitis B comprising administering to said human at least one dose of each of the following:
(i) a priming composition comprising one or more CD8+ T cell epitopes of hepatitis B, which are present in, or encoded by, a non-viral vector, or a viral vector that is non-replicating or replication-impaired in the human; and
(ii) a boosting composition comprising a recombinant poxvirus vector encoding at least one of said one or more CD8+ T cell epitopes of hepatitis B, wherein the recombinant poxvirus vector is non-replicating or replication-impaired in the human;
wherein the viral vector in (i) is derived from a different virus than the viral vector in (ii), and wherein the CD8+ T cell immune response against hepatitis B causes a reduction in hepatitis B viral load in the human.

### Claim 2 (depends on 1)

The method of claim 1 wherein the non-replicating or replication-impaired recombinant poxvirus vector in the boosting composition is a recombinant vaccinia virus.

### Claim 3 (depends on 2)

The method of claim 2 wherein the recombinant vaccinia virus is a recombinant MVA vector.

### Claim 4 (depends on 1)

The method of claim 1 wherein the non-replicating or replication-impaired recombinant poxvirus vector in the boosting composition is a recombinant avipox virus.

### Claim 5 (depends on 4)

The method of claim 4 wherein the recombinant avipox virus is a recombinant fowlpox vector.

### Claim 6 (depends on 4)

The method of claim 4 wherein the recombinant avipox virus is a recombinant canarypox vector.

### Claim 7 (depends on 6)

The method of claim 6 wherein the recombinant canarypox vector is a recombinant ALVAC vector.

### Claim 8 (depends on 1)

The method of claim 1 wherein the priming composition is a recombinant DNA plasmid.

### Claim 9 (depends on 1)

The method of claim 1 wherein the priming composition is a non-viral vector.

### Claim 10 (depends on 1)

The method of claim 1 wherein the priming composition is a viral vector that is non-replicating or replication-impaired in the human.

### Claim 11 (depends on 1)

The method of claim 1 wherein the boosting composition of (ii) is delivered intravenously, intraepidermally, intramuscularly, subcutaneously or intradermally.

### Claim 12 (depends on 1)

The method of claim 1 which further comprises administering an adjuvant.

### Claim 13

A method for generating a CD8+ T cell immune response in a human against hepatitis B comprising administering to said human at least one dose of each of the following:
(i) a priming composition comprising a DNA plasmid encoding one or more CD8+ T cell epitopes of hepatitis B; and
(ii) a boosting composition comprising a recombinant vaccinia virus encoding at least one of said one or more CD8+ T cell epitopes of hepatitis B, wherein the recombinant vaccinia virus is non-replicating or replication-impaired in the human, and
wherein the CD8+ T cell immune response against hepatitis B causes a reduction in hepatitis B viral load in the human.

### Claim 14 (depends on 13)

The method of claim 13 wherein the non-replicating or replication-impaired recombinant vaccinia virus is a recombinant MVA vector.

### Claim 15

A method for generating a CD8+ T cell immune response in a human against hepatitis B comprising administering to said human at least one dose of each of the following:
(i) a priming composition comprising a DNA plasmid encoding one or more CD8+ T cell epitopes of hepatitis B; and
(ii) a boosting composition comprising a recombinant avipox virus encoding at least one of said one or more CD8+ T cell epitopes of hepatitis B,
wherein the CD8+ T cell immune response against hepatitis B causes a reduction in hepatitis B viral load in the human.

### Claim 16 (depends on 15)

The method of claim 15 wherein the recombinant avipox virus is a recombinant fowlpox vector.

### Claim 17 (depends on 15)

The method of claim 15 wherein the recombinant avipox virus is a recombinant canarypox vector.

### Claim 18 (depends on 17)

The method of claim 17 wherein the recombinant canarypox vector is a recombinant ALVAC vector.

### Claim 19

A method for generating a CD8+ T cell immune response in a human against hepatitis B comprising administering to said human at least one dose of each of the following:
(i) a priming composition comprising a DNA plasmid encoding one or more CD8+ T cell epitopes of hepatitis B; and
(ii) a boosting composition comprising a recombinant poxvirus vector encoding at least one of said one or more CD8+ cell epitopes of hepatitis B, wherein the recombinant poxvirus vector is non-replicating or replication-impaired in the human, and wherein the CD8+ T cell immune response against hepatitis B causes a reduction in hepatitis B viral load in the human.

### Claim 20 (depends on 19)

The method of claim 19 wherein the boosting composition of (ii) is delivered intravenously, intraepidermally, intramuscularly, subcutaneously or intradermally.

### Claim 21 (depends on 19)

The method of claim 19 which further comprises administering an adjuvant.

### Claim 22 (depends on 13)

The method of claim 13 wherein the boosting composition of (ii) is delivered intravenously, intraepidermally, intramuscularly, subcutaneously or intradermally.

### Claim 23 (depends on 13)

The method of claim 13 which further comprises administering an adjuvant.

### Claim 24 (depends on 15)

The method of claim 15 wherein the boosting composition of (ii) is delivered intravenously, intraepidermally, intramuscularly, subcutaneously or intradermally.

### Claim 25 (depends on 15)

The method of claim 15 which further comprises administering an adjuvant.