# US 11,993,634 B2 · Recombinant varicella-zoster virus (VZV) vaccine

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- Number: US 11,993,634 B2
- Document ID: US11993634B2
- Status: Granted
- Kind: B2
- Application number: 17/422,835
- Filed: 2020-05-14
- Published: 2022-11-17
- Granted: 2024-05-28
- Earliest claimed: 2019-11-29
- Assignees: Beijing Luzhu Biotechnology Co., Ltd
- Applicants: Beijing Luzhu Biotechnology Co., Ltd.
- Inventors: Jian Kong; Pei Hong Jiang; Ling Peng; Shuai Yang; Leitao Xu; Kun Zhang
- Web page: https://patentgrep.com/patent/US11993634B2

## CPC

- C07K 14/005: from viruses
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 39/12: Viral antigens
- A61K 39/25: Varicella-zoster virus
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/22: for herpes viruses
- A61K 2039/5254: {avirulent or attenuated}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/6056: {Antibodies}
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K 2319/40: containing a tag for immunodetection, or an epitope for immunisation
- C12N 2710/16722: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2710/16734: 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

The present disclosure discloses a recombinant varicella-zoster virus (VZV) vaccine, including a fusion protein formed by an amino acid sequence of an extracellular domain of a recombinant glycoprotein gE of a live attenuated VZV strain (OKA strain) gene and an Fc fragment of human immunoglobulin. The present disclosure further provides preparation and use of the fusion protein, a corresponding recombinant gene, a eukaryotic expression vector, etc. The fusion protein of the present disclosure has prominent immunogenicity and can induce the high-level expression of neutralizing antibodies in serum.

## Claims

### Claim 1

A recombinant varicella-zoster virus (VZV) vaccine preparation, comprising a fusion protein formed by an amino acid sequence of an extracellular domain of a recombinant glycoprotein gE of a live attenuated VZV strain (OKA strain) gene and an Fc fragment of human immunoglobulin, wherein the fusion protein has an amino acid sequence shown in SEQ ID No. 1.

### Claim 2 (depends on 1)

The vaccine preparation according to claim 1, further comprising a vaccine adjuvant.

### Claim 3 (depends on 2)

The vaccine preparation according to claim 2, wherein the vaccine adjuvant is an aluminum hydroxide adjuvant, an aluminum phosphate adjuvant, or a mixture of aluminum hydroxide and aluminum phosphate adjuvants.

### Claim 4 (depends on 1)

The vaccine preparation according to claim 1, wherein each dosage unit of the vaccine preparation comprises 5 μg to 200 μg of the fusion protein.

### Claim 5 (depends on 4)

The vaccine preparation according to claim 4, wherein each dosage unit of the vaccine preparation comprises 10 μg to 100 μg of the fusion protein.

### Claim 6 (depends on 5)

The vaccine preparation according to claim 5, wherein each dosage unit of the vaccine preparation comprises 20 μg to 60 μg of the fusion protein.

### Claim 7 (depends on 1)

The vaccine preparation according to claim 1, further comprising other substances that can enhance immunogenicity, wherein the other substances that can enhance immunogenicity comprise, but are not limited to: phosphatidylcholine (PC), lecithin, 3D-MPL, long-chain fatty acid (ester), mineral oil, vegetable oil, sodium methylcellulose (MC-Na), sodium carboxymethylcellulose (CMC-Na), and cholesterol-containing liposome.

### Claim 8 (depends on 1)

The vaccine preparation according to claim 1, wherein the vaccine preparation is a lyophilized preparation.

### Claim 9 (depends on 8)

The vaccine preparation according to claim 8, wherein the lyophilized preparation is dissolved by an aluminum hydroxide adjuvant suspension before use, and then a resulting mixture is thoroughly mixed and injected intramuscularly or subcutaneously.

### Claim 10 (depends on 1)

A recombinant gene capable of expressing the fusion protein according to claim 1, wherein the recombinant gene has a DNA sequence shown in SEQ ID No. 2.