# US 10,501,529 B2 · Zika virus vaccine composition and application thereof

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- Number: US 10,501,529 B2
- Document ID: US10501529B2
- Status: Granted
- Kind: B2
- Application number: 16/037,502
- Filed: 2018-07-17
- Published: 2019-08-15
- Granted: 2019-12-10
- Earliest claimed: 2018-02-13
- Assignees: National Tsing Hua University
- Applicants: National Tsing Hua University
- Inventors: Suh-Chin Wu; Shao-Ping Yang; Hsiao-Han Lin
- Web page: https://patentgrep.com/patent/US10501529B2

## CPC

- C07K 16/116: Togaviridae (F); Matonaviridae (F); Flaviviridae (F)
- A61K 39/12: Viral antigens
- A61K 47/6839: {the antibody targeting material from viruses}
- A61P 31/14: for RNA viruses
- C07K 14/005: from viruses
- C07K 14/1825: {Flaviviruses or Group B arboviruses, e.g. yellow fever virus, japanese encephalitis, tick-borne encephalitis, dengue}
- A61K 2039/53: {DNA (RNA) vaccination}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2770/24122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2770/24134: 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
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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

Provided herein are a mutant envelope protein of Zika virus and a nucleic acid molecule including a nucleotide sequence encoding the mutant envelope protein. The mutant envelope protein, which preferably has a threonine substitution at 105th position, or an asparagine substitution at 248th position and a threonine substitution at 250th position in an amino acid sequence of SEQ ID NO: 1, includes an N-glycan masking a fusion loop region of the mutant envelope protein of Zika virus. Also provided herein is a vaccine composition, including the mutant envelope protein or a recombinant virus including the nucleic acid molecule. Also provided herein is a method of preventing Zika virus infection and reducing antibody-dependent enhancement of dengue virus infection, including administering to a subject in need thereof an effective amount of a vaccine composition including the mutant envelope protein of Zika virus.

## Claims

### Claim 1

A mutant envelope protein of Zika virus, comprising an N-glycan masking a fusion loop region of the mutant envelope protein of Zika virus, wherein the mutant envelope protein of Zika virus has an asparagine substitution at 248th position and a threonine substitution at 250th position in an amino acid sequence of SEQ ID NO: 1.

### Claim 2 (depends on 1)

A nucleic acid molecule, comprising a nucleotide sequence encoding the mutant envelope protein of Zika virus according to claim 1.

### Claim 3 (depends on 1)

A vaccine composition, comprising the mutant envelope protein of Zika virus according to claim 1.

### Claim 4 (depends on 3)

The vaccine composition according to claim 3, further comprising a precursor membrane protein of Zika virus.

### Claim 5 (depends on 2)

A vaccine composition, comprising a recombinant virus including the nucleic acid molecule according to claim 2.

### Claim 6 (depends on 5)

The vaccine composition according to claim 5, wherein the recombinant virus comprises a gene encoding a precursor membrane protein of Zika virus.

### Claim 7 (depends on 5)

The vaccine composition according to claim 5, wherein the recombinant virus is a recombinant adenovirus.

### Claim 8

A method of preventing Zika virus infection and reducing antibody-dependent enhancement of dengue virus infection, comprising administering to a subject in need thereof an effective amount of a vaccine composition including a mutant envelope protein of Zika virus, wherein the mutant envelope protein of Zika virus comprises an N-glycan masking a fusion loop region of the mutant envelope protein of Zika virus, wherein the mutant envelope protein of Zika virus has an asparagine substitution at 248th position and a threonine substitution at 250th position in an amino acid sequence of SEQ ID NO: 1.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the mutant envelope protein of Zika virus is expressed by a recombinant virus.

### Claim 10 (depends on 9)

The method according to claim 9, wherein the recombinant virus is a recombinant adenovirus.