# US 9,333,253 B2 · Vaccines for inclusion body hepatitis

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- Number: US 9,333,253 B2
- Document ID: US9333253B2
- Status: Granted
- Kind: B2
- Application number: 13/943,990
- Filed: 2013-07-17
- Published: 2013-11-07
- Granted: 2016-05-10
- Earliest claimed: 2009-12-15
- Assignees: University of Saskatchewan; University of Guelph
- Applicants: University of Saskatchewan; University of Guelph
- Inventors: Susantha Gomis; Suresh Kumar Tikoo; Davor Ojkic
- Web page: https://patentgrep.com/patent/US9333253B2

## CPC

- A61K 39/235: Adenoviridae
- A61K 39/12: Viral antigens
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 31/14: for RNA viruses
- A61P 31/20: for DNA viruses
- A61P 37/04: Immunostimulants
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/5254: {avirulent or attenuated}
- A61K 2039/542: {oral/gastrointestinal}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- C12N 2710/10034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/10234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/10251: Methods of production or purification of viral material
- 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)

## Abstract

A composition comprising an isolated fowl adenovirus (FAdV), wherein the FAdV is a strain selected from FAdV-2, FAdV-7, FAdv-8a, FAdV-8b, FAdV-8a/8b or FAdV-11 serotype strains; and a suitable carrier and methods for inducing protective immunity in a subject and/or its progeny.

## Claims

### Claim 1

An immunogenic composition comprising: an immunogenic effective amount of an isolated live and/or killed fowl adenovirus (FAdV), wherein the FAdV is a strain selected from FAdV, x11a-like isolate 04-53357-119 deposited under Accession number 081210-01; FAdV8ab isolate 04-53357-74 deposited under Accession number 081210-02; FAdV-8a, strain TR-59 isolate 04-53357-125 deposited under Accession number 081210-03 and, FAdV11 isolate 06-58730 deposited under Accession number 081210-04 and an effective amount of an adjuvant selected from CpG digodeoxynucleotides, oil-in water emulsified adjuvant or oil-in water emulsified adjuvant with dimethyldioctadecylammonium bromide (DDA) immune-stimulant.

### Claim 2 (depends on 1)

The composition of claim 1 comprising a strain selected from FAdV-8a, strain TR-59 isolate 04-53357-125 deposited under Accession number 081210-03 and, FAdV11 isolate 06-58730 deposited under Accession number 081210-04.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the FAdV is comprised in liver homogenate.

### Claim 4 (depends on 1)

The composition of claim 1 wherein the live FAdV is an attenuated FAdV.

### Claim 5 (depends on 1)

The composition of claim 1 wherein, the composition comprises at least 0.1×106 CCID50, at least 0.2×106 CCID50, at least 0.4×106 CCID50, at least 0.6×106 CCID50, at least 0.8×106 CCID50, at least 0.1×106 CCID50, at least 1×106 CCID50, at least 2×106 CCID50, or at least 3×106 CCID50 virus per dose.

### Claim 6 (depends on 1)

The composition of claim 1 provided in a single or multidose formulation suitably formulated as a liquid formulation, a solid formulation or a spray formulation, for oral; intranasal; eye drop; intramuscular; intradermal; subcutaneous; intravenous and/or in ovo administration.

### Claim 7 (depends on 6)

The composition of claim 6, wherein the oral administration is via drinking water and/or combined with food, and the intranasal administration is via spray.

### Claim 8 (depends on 1)

The composition of claim 1, wherein a particulate delivery system is selected from microparticles, immunostimulatory complexes (ISCOMs) and liposomes.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the composition is provided in combination with one or more poultry vaccines.

### Claim 10 (depends on 1)

The composition of claim 1, wherein the composition is a heterologous vaccine and elicits heterologous protection to one or more strains in addition to the strain and/or serotype comprised in the vaccine.

### Claim 11 (depends on 1)

The composition of claim 1, wherein the FAdV is killed, and comprises an adjuvant.

### Claim 12 (depends on 1)

A method of making a composition of claim 1, wherein the FAdV strain is propagated according to the following method:
i) inoculating a chicken embryonic liver cell culture with the FAdV;
ii) incubating the cell culture at about 30-39° C. to allow the FAdV to propagate;
iii) isolating the propagated FAdV; and
iv) formulating the propagated FAdV with a particulate delivery formulation and adding an effective amount of an adjuvant suitably for administration.

### Claim 13 (depends on 1)

A method for eliciting an immune response in a subject, for producing antibodies in a subject and/or its progeny, or for inducing protective immunity against a FAdV related disease or syndrome in a subject and/or its progeny comprising administering the composition of claim 1 to the subject.

### Claim 14 (depends on 1)

A kit comprising the composition of claim 1.