# US 9,517,260 B2 · Treatment of pigs with PCV2 antigen

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- Number: US 9,517,260 B2
- Document ID: US9517260B2
- Status: Granted
- Kind: B2
- Application number: 14/483,097
- Filed: 2014-09-10
- Published: 2014-12-25
- Granted: 2016-12-13
- Earliest claimed: 2006-12-15
- Assignees: Boehringer Ingelheim Vetmedica GmbH
- Applicants: Vicky Fachinger; Knut Elbers; Axel Lischewski; Marion Kixmoeller; Francois-Xavier Orveillon; Isabelle Freiin von Richthofen; Michael D. Piontkowski
- Inventors: Vicky Fachinger; Knut Elbers; Axel Lischewski; Marion Kixmoeller; Francois-Xavier Orveillon; Isabelle Freiin von Richthofen; Michael D. Piontkowski
- Web page: https://patentgrep.com/patent/US9517260B2

## CPC

- A61K 39/12: Viral antigens
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61K 31/7036: having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
- A61P 31/20: for DNA viruses
- 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 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- C12N 2750/10034: 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
- 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 relates to a method for the treatment or prophylaxis of a PCV2 infection or for reduction of clinical symptoms caused by or associated with a PCV2 infection in animals a) having anti-PCV2 antibodies and/or b) being young piglets of 1 to 22 days of age, comprising the step of administering an effective amount of a PCV2 antigen to that animal in need of such treatment. Preferably, those animals are pigs or young piglets.

## Claims

### Claim 1

A method for the treatment of
a) PCV2 infection; or
b) clinical symptoms caused by or associated with a PCV2 infection in piglets, wherein the piglet has anti-PCV2 antibodies, the method comprising the step of administering a single efficacious dose of an immunogenic composition comprising a PCV2 ORF2 antigen to a piglet.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said anti-PCV2 antibodies are maternal antibodies.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the immunogenic composition comprising PCV2 ORF2 antigen is administered at day 7 of age or later.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the immunogenic composition comprising PCV2 ORF2 antigen is administered at day 14 of age or later.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the immunogenic composition comprising PCV2 ORF2 antigen is administered not later than at week 7 of age.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the treatment results in shortening of the viremia phase of 5 or more days as compared to piglets of a non-treated control group.

### Claim 7 (depends on 1)

The method according to claim 1, wherein said PCV2 ORF2 antigen is expressed by a recombinant baculovirus prior to administration.

### Claim 8 (depends on 1)

The method according to claim 1, wherein said PCV2 ORF2 antigen is included in Ingelvac® CircoFLEX™.

### Claim 9 (depends on 1)

The method according to claim 1, wherein said treatment of PCV2 infection results in an improvement in comparison to piglets of a non-treated control group in a vaccine efficacy parameter selected from the group consisting of a reduction in the loss of weight gain, a shorter duration of viremia, a lower virus load, or any combination thereof.

### Claim 10 (depends on 1)

The method of claim 1, wherein the piglet has anti-PCV2 antibodies with an anti-PCV2 antibody titer of at least 1:100-1:320 as determined in a PCV-specific indirect immunofluorescence assay.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the piglet has said anti-PCV2 antibody titre at the time the immunogenic composition comprising PCV2 ORF2 antigen is administered.

### Claim 12 (depends on 1)

The method of claim 1, wherein the piglet has anti-PCV2 antibodies with an anti-PCV2 antibody titer of up to 1:1000 as determined in a PCV-specific indirect immunofluorescence assay.

### Claim 13 (depends on 1)

The method of claim 1, wherein the piglet has anti-PCV2 antibodies with an anti-PCV2 antibody titer of greater than 1:1000 as determined in a PCV-specific indirect immunofluorescence assay.

### Claim 14

A method for the treatment of a PCV2 infection or for the reduction of the severity of clinical symptoms caused by PCV2 infection in piglets, wherein the piglets have anti-PCV2 antibodies with an anti-PCV2 antibody titer of more than 1:1000 as determined in a PCV-specific indirect immunofluorescence assay, comprising administering a single efficacious dose of a vaccine composition comprising a PCV2 ORF2 antigen to a piglet wherein the treatment of PCV2 infection or the reduction of the severity of clinical symptoms caused by or associated with a PCV2 infection occurs after the single efficacious dose of the vaccine composition comprising PCV2 ORF2 antigen.

### Claim 15 (depends on 14)

The method of claim 14, wherein the PCV2 ORF2 antigen is a PCV2 ORF2 protein.

### Claim 16 (depends on 14)

The method of claim 14, wherein the anti-PCV2 antibodies are maternally-derived antibodies.

### Claim 17 (depends on 14)

The method of claim 14, wherein the vaccine composition comprising PCV2 ORF2 antigen is administered at day 7 of age or later.

### Claim 18

A method for the treatment of PCV2 infection in a piglet or for the reduction of the severity of clinical symptoms caused by or associated with a PCV2 infection in a piglet, wherein the piglet has anti-PCV2 antibodies, the method comprising the step of:
administering a single efficacious dose of an immunogenic composition comprising PCV2 ORF2 protein to a piglet, wherein the PCV2 ORF2 protein has at least 90% sequence homology with SEQ ID NO. 11 and wherein the treatment of PCV2 infection or the reduction of the severity of clinical symptoms caused by or associated with a PCV2 infection occurs after the single efficacious dose of said immunogenic composition comprising PCV2 ORF2 protein.

### Claim 19 (depends on 18)

The method of claim 18, wherein the piglet has anti-PCV2 antibodies with an anti-PCV2 antibody titer of at least 1:1001:320 as determined in a PCV-specific indirect immunofluorescence assay.
