# US 12,005,113 B2 · Porcine epidemic diarrhea virus strains and immunogenic compositions therefrom

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- Number: US 12,005,113 B2
- Document ID: US12005113B2
- Status: Granted
- Kind: B2
- Application number: 17/021,261
- Filed: 2020-09-15
- Published: 2022-03-24
- Granted: 2024-06-11
- Earliest claimed: 2015-02-27
- Assignees: Zoetis Services LLC; Iowa State University Research Foundation, Inc.
- Applicants: Iowa State University Research Foundation, Inc.; Zoetis Services LLC
- Inventors: Jianqiang Zhang; Qi Chen; Phillip Gauger; Darin Madson; John Morgan Hardham; Meggan Bandrick; Jay Gregory Calvert; James Richard Thompson; Mira Ivanova Stoeva; Walter Valdez
- Web page: https://patentgrep.com/patent/US12005113B2

## CPC

- A61K 39/215: Coronaviridae, e.g. avian infectious bronchitis virus
- A61K 39/12: Viral antigens
- A61P 1/12: Antidiarrhoeals
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- C07K 14/165: Coronaviridae, e.g. avian infectious bronchitis virus
- A61K 2039/51: {comprising whole cells, viruses or DNA/RNA}
- A61K 2039/552: {Veterinary vaccine}
- C12N 2770/20034: 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 is directed to novel nucleotide and amino acid sequences of Porcine Epidemic Diarrhea Virus (“PEDV”), including novel genotypes thereof, all of which are useful in the preparation of vaccines for treating and preventing diseases in swine and other animals. Vaccines provided according to the practice of the invention are effective against multiple swine PEDV genotypes and isolates. Diagnostic and therapeutic polyclonal and monoclonal antibodies are also a feature of the present invention, as are infectious clones useful in the propagation of the virus and in the preparation of vaccines. Particularly important aspects of the invention include polynucleotide constructs that replicate in tissue culture and in host swine. The invention also provides for novel full length PEDV genomes that can replicate efficiently in host animals and tissue culture.

## Claims

### Claim 1

A vaccine composition comprising an isolated porcine epidemic diarrhea virus (PEDV) encoded by a DNA polynucleotide sequence that is SEQ ID NO: 36 or SEQ ID NO: 37, and a carrier,
wherein said composition is capable of protecting swine from challenge by both variant and prototype strains of PEDV and preventing or treating one or more symptoms associated with PEDV infection,
wherein achievement of protection is determined by an endpoint selected from the group consisting of prevention or control of any of the PEDV infection symptoms of dehydration, fever, diarrhea, vomiting, poor lactational performance, poor reproduction performance, mortality, and prevention or control of weight loss or failure to gain weight,
wherein said protected swine include any of sows, gilts, boars, hogs, and piglets and
wherein said vaccine is effective in a single dose program or in a two dose program, and wherein the minimum effective dose is about 104 log10TCID50/dose.

### Claim 2 (depends on 1)

The vaccine composition of claim 1, wherein said vaccine is effective in a two dose program and wherein the first dose is administered when the piglet is about 1-7 days old, and the second dose is administered when the piglet is 2-5 weeks old.

### Claim 3 (depends on 1)

The vaccine composition of claim 1, wherein said vaccine is effective in a single dose program and wherein the single dose is administered at about 1-21 days old.