# US 11,110,159 B2 · Methods for inducing an immune response

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- Number: US 11,110,159 B2
- Document ID: US11110159B2
- Status: Granted
- Kind: B2
- Application number: 15/747,671
- Filed: 2016-07-25
- Published: 2018-09-06
- Granted: 2021-09-07
- Earliest claimed: 2015-07-27
- Assignees: Glaxosmithkline Biologicals SA
- Applicants: Glaxosmithkline Biologicals, SA
- Inventors: Marie-Ange Demoitie; Marie-Noelle Renelle Donner; Nadia Ouaked
- Web page: https://patentgrep.com/patent/US11110159B2

## CPC

- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 35/761: Adenovirus
- A61K 39/12: Viral antigens
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 45/05: {Immunological preparations stimulating the reticulo-endothelial system, e.g. against cancer}
- A61P 31/06: for tuberculosis
- C07K 14/005: from viruses
- C07K 14/35: from Mycobacteriaceae (F)
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12N 15/85: for animal cells
- C12N 15/86: Viral vectors
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C12N 2710/10321: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2710/10341: Use of virus, viral particle or viral elements as a vector
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2740/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/18534: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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)

## Abstract

The present invention relates to methods for inducing an immune response, in particular methods for inducing an immune response against mycobacterial infections or disease comprising (i) at least one administration of a polypeptide Rv1196 related antigen and at least one administration of an adenovirus encoding a Rv1196 related antigen or (ii) at least one administration of a polypeptide Rv0125 related antigen and at least one administration of an adenovirus encoding a Rv0125 related antigen. Associated compositions, adenoviral constructs and polynucleotide sequences are also provided.

## Claims

### Claim 1

A method for inducing an immune response comprising a T cell response in a subject comprising:
administration of a chimpanzee adenovirus encoding a Rv1196 related antigen comprising SEQ ID NO: 1, followed by administration of a polypeptide Rv1196 related antigen to the subject, wherein the polypeptide Rv1196 related antigen is provided in a composition which also comprises an adjuvant.

### Claim 2 (depends on 1)

The method of claim 1 wherein the adjuvant comprises a Toll Like Receptor (TLR) agonist and/or an immunologically active saponin.

### Claim 3 (depends on 1)

The method of claim 1 wherein the adjuvant comprises 3-O-deacylated monophosphoryl lipid A (3D-MPL).

### Claim 4 (depends on 1)

The method of claim 1 wherein the adjuvant comprises QS21.

### Claim 5 (depends on 1)

The method of claim 1 wherein the chimpanzee adenovirus is a ChAd3.

### Claim 6 (depends on 1)

The method of claim 1 wherein the chimpanzee adenovirus is a ChAd63.

### Claim 7 (depends on 1)

The method of claim 1, wherein the Rv1196 related antigen comprises SEQ ID NO: 6.

### Claim 8 (depends on 1)

The method of claim 1, wherein the composition in which the polypeptide Rv1196 related antigen provided is substantially free of a non-human simian adenovirus encoding the Rv1196 related antigen.

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition in which the polypeptide Rv1196 related antigen provided does not comprise a non-human simian adenovirus encoding the Rv1196 related antigen.