# US 10,864,263 B2 · Method of providing safe administration of adenoviral vectors encoding a zika virus antigen

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- Number: US 10,864,263 B2
- Document ID: US10864263B2
- Status: Granted
- Kind: B2
- Application number: 16/194,868
- Filed: 2018-11-19
- Published: 2019-05-23
- Granted: 2020-12-15
- Earliest claimed: 2017-11-20
- Assignees: Janssen Pharmaceuticals, Inc.; Beth Israel Deaconess Medical Center, Inc.
- Applicants: Janssen Pharmaceuticals, Inc.; Beth Israel Deaconess Medical Center, Inc.
- Inventors: Dan Barouch; Macaya Julie Douoguih; Gaston Rafael Picchio
- Web page: https://patentgrep.com/patent/US10864263B2

## CPC

- A61K 39/12: Viral antigens
- 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 47/6901: {Conjugates being cells, cell fragments, viruses, ghosts, red blood cells or viral vectors}
- A61P 31/14: for RNA viruses
- A61K 2039/6075: {Viral proteins}
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- 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
- 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 are methods for generating an immune response against a Zika virus in a human subject in need thereof. The methods comprise administering to the subject a pharmaceutical composition comprising adenoviral vectors encoding a Zika virus antigen and a pharmaceutically acceptable carrier.

## Claims

### Claim 1

A method for generating an immune response against a Zika virus in a human subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising adenoviral vectors of the Ad26 serotype comprising a nucleic acid sequence encoding a Zika virus antigen, wherein the Zika virus antigen comprises the amino acid sequence of SEQ ID NO:2, and a pharmaceutically acceptable carrier, wherein about 5×1010 adenoviral vectors to about 1×1011 adenoviral vectors are administered per dose to the subject in need thereof, and wherein the pharmaceutical composition is administered in two doses to the human subject in a prime-boost regimen.

### Claim 2 (depends on 1)

The method of claim 1, wherein about 5×1010 adenoviral vectors are administered per dose to the subject in need thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein about 1×1011 adenoviral vectors are administered per dose to the subject in need thereof.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered via an intramuscular injection to the subject in need thereof.

### Claim 5 (depends on 1)

The method of claim 1, wherein the first and second dose of the pharmaceutical composition are administered to the human subject about four weeks, about eight weeks, about twelve weeks, about three months, about six months, about nine months, about one year, or about two years apart.

### Claim 6 (depends on 5)

The method of claim 5, wherein the first and second dose of the pharmaceutical composition are administered to the human subject about eight weeks apart.