# US 10,117,926 B2 · Respiratory syncytial virus vaccine

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- Number: US 10,117,926 B2
- Document ID: US10117926B2
- Status: Granted
- Kind: B2
- Application number: 15/197,001
- Filed: 2016-06-29
- Published: 2016-12-01
- Granted: 2018-11-06
- Earliest claimed: 2010-11-15
- Assignees: Vib Vzw; Universiteit Gent
- Applicants: Vib Vzw; Universiteit Gent
- Inventors: Xavier Saelens; Bert Schepens; Walter Fiers
- Web page: https://patentgrep.com/patent/US10117926B2

## CPC

- A61K 39/155: Paramyxoviridae, e.g. parainfluenza virus
- A61K 39/12: Viral antigens
- A61K 39/385: Haptens or antigens, bound to carriers
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- C07K 7/06: having 5 to 11 amino acids
- C07K 14/005: from viruses
- C07K 14/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
- C07K 16/11: Paramyxoviridae (F); Pneumoviridae (F), e.g. respiratory syncytial virus [RSV]
- 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 7/02: Recovery or purification
- A61K 2039/5258: {Virus-like particles}
- A61K 2039/543: {intranasal}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55544: {Bacterial toxins}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/575: {humoral response}
- A61K 2039/6031: {Proteins}
- A61K 2039/6075: {Viral proteins}
- A61K 2039/6081: {Albumin; Keyhole limpet haemocyanin [KLH]}
- A61K 2039/645: {Dendrimers; Multiple antigen peptides}
- C07K 2317/10: characterized by their source of isolation or production
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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 2760/18571: Demonstrated in vivo effect
- 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

Described is a vaccine against Respiratory Syncytial Virus (RSV). More specifically, described is a recombinant subunit vaccine comprising the ectodomain of the RSV-encoded Small Hydrophobic (SH) protein. The ectodomain of SH is referred to as SHe. The ectodomain is typically presented as an oligomer, or pentamer. Further described are antibodies, raised against the ectodomain or specific for the ectodomain, and their use for protecting a subject against RSV infection and/or for treatment of an infected subject.

## Claims

### Claim 1

A method of evoking protective immunity in a subject against Respiratory Syncytial Virus infection, the method comprising: administering to a subject in need thereof an immunogenic composition comprising the ectodomain of the small hydrophobic protein of a Respiratory Syncytial Virus, wherein the ectodomain comprises SEQ ID NO: 3, has a length of 23 or 24 amino acids, and has at least 80% sequence identity to SEQ ID NO: 1 or 2, and wherein the composition comprises a carrier heterologous to the ectodomain.

### Claim 2 (depends on 1)

The method of claim 1, wherein said ectodomain is presented as an oligomer.

### Claim 3 (depends on 1)

The method of claim 1, wherein said ectodomain is genetically linked to the carrier.

### Claim 4 (depends on 1)

The method of claim 1, wherein said ectodomain is chemically linked to the carrier.

### Claim 5 (depends on 1)

The method of claim 1, wherein said carrier is an oligomer.

### Claim 6 (depends on 5)

The method of claim 5, wherein said oligomer is a pentamer.

### Claim 7 (depends on 1)

The method of claim 1, wherein said carrier is selected from the group consisting of Cartilage Oligomeric Matrix Protein (COMP), Lpp-56, and a virus-like particle.

### Claim 8 (depends on 1)

The method of claim 1, comprising administering said immunogenic composition to the subject prior to exposure of the subject to Respiratory Syncytial Virus.

### Claim 9 (depends on 1)

The method of claim 1, wherein said carrier is a non-proteinaceous carrier.

### Claim 10 (depends on 9)

The method of claim 9, wherein said non-proteinaceous carrier is a liposome.

### Claim 11 (depends on 1)

The method of claim 1, wherein said ectodomain has at least 85% sequence identity to SEQ ID NO: 1 or 2.

### Claim 12 (depends on 1)

The method of claim 1, wherein said ectodomain has at least 90% sequence identity to SEQ ID NO: 1 or 2.

### Claim 13 (depends on 1)

The method of claim 1, wherein said ectodomain has at least 95% sequence identity to SEQ ID NO: 1 or 2.

### Claim 14 (depends on 1)

The method of claim 1, wherein said ectodomain comprises a sequence selected from SEQ ID NO: 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16.

### Claim 15 (depends on 1)

The method of claim 1, wherein said ectodomain is linked to a hinge or spacer sequence.